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EMPLOYMENT

If you are looking for a position and would like to place a short ad (approx. 250 characters), please contact::
Eleanor Chilson Program & Placement Chair 954-428-7373 x245 echilson@pylonhq.com

and leave a message with your phone number or email echilson@pylonhq.com  This service is free to members of ASQ Section 1510.   Any South Florida area business with an opening for a quality related position may also place an announcement.  This is not limited to space (subject to availability) and you do not have to be a member.

Ads for individuals seeking positions are free to ASQ Section 1510 / 1515 members and subject to space availability.  Ads for open positions in a quality related field are free and not limited to ASQ members. To place an ad, contact  Placement Chair, Eleanor Chilson, (954)428-7373 x245, or echilson@pylonhq.com  

 

Director of Process Management (May 08)

Kaplan Virtual Education (KVE) is a leader in the growing field of virtual high school instruction and online curriculum development.  As we continue to grow, we seek a Director of Process Management to proactively recognize and address issues that will lead to greater organizational effectiveness.  Responsibilities include:  data acquisition, analysis and management; creation and management of operational business processes, controls and audits for the purpose of continuous improvement; documentation and status reporting.  Projects will follow organizationally accepted methodologies such as BPMS, DMAIC, DMADV, TQM, TRIZ, TOC, PDCA, PMI.  Requirements:  Masters Degree in Industrial Engineering, Process Management, Six Sigma, TQM, Project Management; 5+ years of process improvement / change management experience; 3-5 years of Service Organization experience; knowledge of current & long-term trends in education; strong leadership skills.  Qualified candidates should submit resume and salary requirements to mbiggs2@kaplan.edu.

Mechanical Inspector (May-08)

 Candidates must have prior experience with: 
-Micrometers
-Calipers 
-Optical Comparator 
-Must be able to read Blueprints and Schematics
-close tolerances 
-fast passed production environment

 Experience with this would be a plus: 
-Geometric Dimensioning and Tolerancing (GD&T) would be a plus
-Smart Scope would be a plus
-hours are from 7:30am-5pm (5 hours of overtime weekly)
-Temp to perm

 The position is located in Tamarac and it is a Metal Processing plant.

 Contact Information

 John Ross 954-717-3553 or joross@aerotek.com

Quality Control Manager (May 08)

 1.      Bachelors Degree (Masters a plus)

2.      Minimum three (3) years experience in ISO 9001 or AS9100 Aerospace environment

3.      Minimum three (3) years as a quality control manager

4.     Experience in Manufacturing environment, a plus with experience in Machining, Injection  Molding, and Assembly processes

5.      Experience with Dimensional Measurement, Electrical, and Functional Testing

6.      Minimum three (3) years auditing experience

7.      ASQ Certified Quality Manager and/or Certified Quality Engineer a plus

8.      Experience Managing staff of ten (10) or more

9.      Excellent written and oral communications skills

10. Project Management experience preferred

11. Preferred skills in: Organizational Leadership, Team Processes and Team facilitation, Strategy Development and Deployment Leadership, Strategic planning and assessment, Quality Function Deployment, and Logistics and supply chain management

12. Skilled in Quality Management Tools, such as: Problem-solving tools, Root Cause analysis, Plan-Do-Check-Act (PDCA) , Six-Sigma, and similar models

13. Measurement: Assessment and Metrics, Total Quality Management. Project Management, and ability to deliver effective Training

14. Ability to perform job functions with little or no supervision

15. Proficiency in Microsoft Office (PowerPoint, Word, Excel, Visio, and others)

16. Training in ISO 9001:2000 auditing

17. Bilingual (English/Spanish) a plus

 Responsibilities:

 1.      Maintain Qualified Product Listing (QPL) for Military / DSCC products

2.      Manage Staff of QC Inspectors

3.      Maintain Stamp Roster

4.      Maintain established QC procedures, work instructions, and technical data

5.      Provide QC Metrics for Company Dashboard

6.      Address Customer, Supplier, Internal, and Corrective/Preventive Action Requests in accordance with established procedures.

7.      Ensure processes needed for the inspection activities are established, implemented, and maintained

8.      Ensure staff is productive and adequately trained.

9.      Manage Corrective Action Processes and maintain CAR Logs.

10. Work with Materials, Engineering and Production Departments to resolve issues as they arise.

11. Participate on Customer, Internal, and Supplier Audits.

Please contact Fred Gilliam f_gilliam@hotmail.com 954-295-0245.

   

 Quality Assurance/Validation Engineer (Apr. 08)

 Diamedix , an ISO Certified and FDA registered medical device manufacturer of ELISA kits, is looking for a Quality Assurance/Validation Engineer.  This position reports to the Director, QA/RA.  To apply, please send resume to glenn_gerstenfeld@ivaxdiagnostics. com, or fax to 305-323-2585, Attn: QA Department.

 Essential Functions and Responsibilities

1.   Maintains and coordinates the Product and Process Validation Program.  Maintains      prioritizes, and implements the Master Validation Plan. Develops IQ, OQ, and PQ protocols, assists in their execution, and prepares final reports.  Assists Manufacturing and other departments in the preparation/execution of validation protocols.

2.   Supervises and coordinates the Calibration Program for all instruments.  Creates,              reviews, and/or revises associated Standard Operating Procedures (SOPs). 

3.   Manages the Supplier Quality Assurance Program; evaluates/qualifies new suppliers, maintains/revises the Approved Supplier List (ASL), and conducts supplier audits as required. 

4.   Conducts internal quality audits and prepares audit reports for management  review.  Also performs QA oversight activities of the Manufacturing areas.

5.   Perform various QA support functions, as needed/requested.

 Minimum Qualifications

This job requires a four-year degree in a Science discipline with at least 4 years of relevant work experience in the medical device or pharmaceutical industry (or a combination of education and experience), particularly in Quality Assurance or Quality Control.  Must have 3-5 years experience in validation of processes/equipment.

Working knowledge of quality systems is required. Strong technical knowledge of cGMP/FDA 21CFR 820 (QSR), ISO 13485:2003, and CMDR regulations and audit methodologies is required.  Broad experience and skill in conducting and documenting non-conformance investigations.  Computer literate: able to use word processing, spreadsheet programs, databases, etc.  Ability to read, analyze, and interpret technical procedures and government regulations.  Excellent writing skills with the ability to write reports and procedures.  Experience in auditing for cGMP, ISO 13485, and CMDR compliance.  Excellent organizational, communication and presentation skills are essential.  Good interpersonal skills to interact with all levels of the company.   

Quality Engineer (Apr. 08)

B/E Aerospace (Medley) has been designing and producing premium seating accommodations called Super First Class, for long haul international commercial aircrafts, growing into a dominant role in the market segment.  In 2007, B/E Aerospace (Medley) introduced our next generation seating platform referred to as Ultimate Comfort Technology.  B/E Aerospace (Medley) is a fully integrated operation with on-site sales and marketing, engineering and FAA certification for product development, manufacturing and support.

 Job Title:        Quality Engineer                    Department:   Quality Assurance

FLSA Status:  Exempt

 Summary:  Plans and directs activities concerned with development, application and maintenance of quality standards for industrial processes, materials and products by performing the following duties.

 Essential Duties & Responsibilities:  Develops and applies advanced Quality Engineering theories, methods and research techniques in the development, establishment and maintenance of quality assurance/control policies, procedures and methods.

 Develops sampling plans, quality standards and quality control instructions to be utilized by manufacturing, test and inspection in assessing the quality levels of products and processes.

 Provides recommendations concerning the disposition of defective materials.

 Reviews corrective actions recommended on audit reports for adequacy and to maintain a continuing awareness of quality problems.

 Conducts investigations of considerable complexity pertaining to the manufacture of new products, the establishment of new processes or the resolution of complex product quality problems.

 May provide technical guidance to lower level engineers, technicians and inspectors.

 Performs other related duties as required.

 Education and/or Experience:     Bachelor's degree in Engineering; and minimum five years related experience and/or training.

Apply via our website:  For complete details of job posting and to apply, please reference our website www.beaerospace.com under careers and job listings in Medley, FL.

Quality Control Inspector (April 08)

Description

Local South Florida firm seeking an experienced Quality Control Inspector to complement and enforce existing ISO-9000 Quality Management System. Knowledge of ISO-9000 Quality System required. Prior Quality Inspector/Engineering/Manufacturing experience required. Strong communication skills required. Please send resume and salary requirements via email to qualitymanager@hosemccann.com or via fax to 954-429-0987.

Hose-McCann Communications

1241 West Newport Center Drive

Deerfield Beach, FL 33442

Angie Steele
Quality Control Manager
Telephone: 954-429-1110 Ext. 239
Fax: 954-429-1130
www.hosemccann.com

System Engineer (Mar 08)

Company:

The company is Spectranetics - a Class III medical device manufacturer in the Cardiovascular industry. The company is located in Colorado Springs, Colorado. 

Job Description:

Provide leadership of QA resources applied to each Project and System for the full lifecycle of the Product, Service, or System as needed per New Product Introduction and Design Controls. Develop, Update, and Maintain SOPs, Forms, Methods related to Quality in the NPI/DC SOP and Risk Management System. Leverage lessons learned / successes across Products and Systems (all Quality aspects of NPI/DC and Risk Management). Support consistent methodologies and assessments between various Products and Systems. Lead training and support of Quality elements of NPI/DC SOP and Risk Management including updates as needed. Ensure Risk Management is effective utilizing feedback from Validation, Field Safety, Manufacturing indicators, CAPA’s, HHA’s, …. Lead or support Health Hazard Analysis to ensure risk assessment and root cause analysis across products and systems.

Product / System specific job descriptions:

These are performed by the ‘Design Control / Risk Management Coordinator QE’ or are assigned by this Engineer to another QE for specific Products and Systems. The assigned person is the Quality Representative (primary point of contact and Quality lead) for the Product / System. The assigned person can be changed during the lifecycle. Coordination of Quality aspects of Design Control System (NPI/DC SOP). Coordinate Quality resources the Product or System. Utilize personal resources (direct contribution), other Quality personnel, Subject Matter Experts (Internal and/or External), contracted personnel or services, and/or consultant personnel to ensure proper expertise and experience is utilized in supporting Quality requirements. Ensure proper application of Design Controls and Risk Management Assessments. Develop and Maintain specific documentation for project, including integrity of the project DHF. Support CAPA risk assessment directly or through coordination with assigned QE.

Experience/Skills

Design control and new product introduction process

4 Years specific engineering experience (medical device)

Good understanding & experience in advanced problem solving including statistical techniques

4 Years experience in application and leading problem-solving, root cause analysis and related Corrective and Preventive Actions (including verification)(CAPA)

Sound understanding of quality concepts, regulatory compliance requirements and tools including ISO 13485;2003 and the FDA QSR

Must be able to read blueprints and diagrams. CAD experience a plus.

Must be computer proficient (Microsoft Office Suite required). Ms-Project, Mini-Tab or JMP (statistics) and Visio (flowcharting) experience a plus.

Proven ability to lead (influence) in a cross-departmental technical environment

Experience with ALARP, Design Risk Management and Post-production Risk Management

Education

BS, Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline

ASQ Certified Quality Engineer a plus

Green Belt or Black Belt certification in Six Sigma / Lean Sigma

A relocation package will be made available

forward resume to: 


Spectranetics
9965 Federal Drive
Colorado Springs, Colorado 80921

Attn: Les Rodriguez
Director Quality Assurance and Engineering
Les.Rodriguez@spectranetics.com
Phone:
719-306-3330

Process Engineer (March 08)

Company Overview:

 3-D Machining is a manufacturer of high precision machined parts, Medical Device components and electromechanical assemblies using materials such as Titanium, Aluminum, Stainless Steel and Plastic.

Please visit our website www.3d-machining.com.

 Process Engineer   Fast paced Medical device component manufacturer is seeking a Process engineer with previous experience in a machining or medical device environment.

This individual will be responsible for:

(1)  Developing the Inspection criteria and methods for incoming, in-process, and final inspection.

(2)  Generation of and supervision of process capability studies

(3)  Process and product problem solving and,

(4)  Act as intermediary with the customer in regards to drawing specifications/inspection requirements, customer rejections and returns

 Requirements:

 Must have related manufacturing environment experience

Must have a thorough understanding of GD&T symbology and application

Must be capable of writing detailed inspection procedures

Must be a self-starter and capable of handling multiple tasks

Additional skills preferred:

A thorough knowledge of measuring equipment manual and Automated. Certified Green Belt or higher, or have a skill set comparable

At least 3 years of experience as a Process or Quality Engineer

Compensation:

Pay Rate based on experience and is competitive

Paid Holidays, Vacation and Sick

Health, Dental & Life Insurance available

Company sponsored 401K Plan & Bonus

Contact:

Donna Artola

Manager Human Resources

561-842.7175 phone

561-842.7119 Fax

donnaa@3d-machining.com Email

 

Job Title: Quality Engineer II (March 08)                                              

Posting Date: March 12, 2008

Company Name: The Anspach Companies, Palm Beach Gardens , FL 33410

Contact: Heather Tanksley, Contract Recruiter @ 561-627-1080 x8502 or send resume and cover letter in Word format to HR@Anspach.com.

 Description:

Develops & initiates standards/procedures & methods for inspection, testing, validation/verification & evaluation; Develops and/or updates procedures and instructions for recording, evaluating, and reporting quality and reliability data; Establishes programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities; Develops and implements methods and procedures for disposition of discrepant material; Directs workers engaged in measuring and testing products, process quality and reliability; Compiles and writes training material and conducts training sessions on quality control activities; A Quality Engineer assigned Internal Audit duties schedules and performs audits of the Quality System to assess compliance with US (FDA), and foreign (European – MDD, Canadian – CMDCAS, etc.) regulations and standards, including the Quality Manual, Operating Procedures, ISO 13485 and other standards as applicable. Documents and reports audit results to management. Initiates corrective and preventive actions (CAPA) and verifies their adequacy prior to closure; Re-audits CAPA effectiveness in subsequent quality audits; Assists Management Representative in identifying Q-System areas requiring improvements, recommending changes, and developing and delivering auditing training. Develops annual audit schedule, individual audit agendas, and audit check sheets; Communicates detailed schedule and agenda to management prior to conducting audit. Reports audit results and assigns CAPA. Complies with and advises improvements to audit procedure(s); May conduct supplier audits.

Job Title: Quality Assurance Technician (2nd Shift, M-T, 3:30pm to 2:00am) (March 08)

Posting Date: March 12, 2008

Company Name:  The Anspach Companies, Palm Beach Gardens , FL 33410

Contact: Heather Tanksley, Contract Recruiter @ 561-627-1080 x8502 or send resume and cover letter in Word format to HR@Anspach.com.

 Description:

 2nd Shift - Tests and inspects products at various stages of the production process and compiles and evaluates statistical data to determine and maintain quality and reliability of products. One year related experience in quality inspection is required; H/S diploma or GED and the ability to read and comprehend engineering drawings and procedures is required.

Biomet 3i

Job Title:                      Senior Regulatory Compliance Specialist (March 08)

Reports to:                   Regulatory Compliance Manager

 Summary: Equal Opportunity Employer

  Support Regulatory Compliance Manager and be responsible for facilitating quality and regulatory compliance pursuant to federal, international and corporate regulatory requirements and standards.

 Essential Duties and Responsibilities:

Manage all aspects of the Biomet 3i Internal Quality System Audit Program to assess compliance with US and International Regulations and Quality System Standards.

 As required, support due diligence efforts or Purchasing Controls through performance of supplier audits to ensure Biomet 3i requirements are met.

 Maintain expert knowledge of Domestic and International Regulatory requirements needed to plan, conduct, and report to management the audit results.

 Provide recommendations or assistance in root cause investigations and in implementing systematic corrective and preventative actions.

 Assess effectiveness of completed corrective actions and report results.

 Participate in the development, collection and preparation of data for corporate regulatory compliance reports and Management Review Meetings.

 Participate in the development and implementation of standard operating procedures, as they would relate to the quality system and regulatory requirements.

 Participate in the dissemination of Regulatory information and compliance information, including the training of team members on these areas.

 Assist in the development of internal auditor candidates through mentoring and training of good audit practices.

 Provide support for 3rd party audits (FDA, Notified Body) as needed.

 Provide regulatory support in the areas of quality planning and software and/or process validation through protocol development, execution and summary, as needed.

 Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. 

 Education and/or Experience:  Bachelor’s degree or higher. (5) years of practical medical device regulatory experience preferred; an in-depth working knowledge of FDA and regulations and how to interpret and monitor them with experience or knowledge in Quality Systems relating to 21 QSR Part 820 and ISO 13485:2003 and working knowledge of CAPA, Quality Planning, Process Validation, Risk Management and Quality Auditing.  ASQ Auditor Certification preferred.

Excellent computer skills required, including Microsoft Excel, PowerPoint and Word.

Interested applicants should email there resume to jobs@3implant.com

Matt Fischer
561-776-6796
Professional Staffing Specialist
Biomet 3i, Inc

 
Quality Assurance Specialist Position (Feb 08)

The ideal candidate will have the following skills/capabilities:

Read and interpret drawings and engineering specifications

Familiarity with AWS and ASME welding requirements and be capable of inspecting welds

Inspect completed mechanical assemblies for dimensional compliance, cleanliness, complete documentation and witness pressure testing

Ability to use simple inspection tools such as bore gauges, profilometer, micrometers, fillet gauges and calipers

Must be capable in MS Office, primarily word and excel

Should be able to verify electrical assemblies for completeness to include

Verification of completed point to point check documentation and spot check results

Verification of component mounting and wire routing

Verification of completed assembly's adherence to drawings and specifications

Be familiar with ISO quality requirements and documentation

Must be able to aid in the development of documented processes or updating established processes

Must be able to communicate effectively and contribute positively in all aspects of project execution

Technical background is highly desirable. College degree is not required but two years higher education or equivalent. Equivalent could be work experience, technical school or military training, etc.

Should have 3-5 years experience. Salary range is $45-60,000 but may be flexible for the right candidate.

Interested candidates can email or call me and should provide their current salary.

Robert Y. Cunningham
ryc@profiledistillers.com

914-241-2450

Verify / VSC is continually searching for candidates to support with source inspections (in-process, final, FAI), audits / surveys, supplier surveillance, and other quality assurance activities in the Southern Florida area. We support most of the top aerospace and military-industrial companies in the world – i.e. Lockheed Martin, Boeing, Northrop Grumman, General Dynamics, UTC – Sikorsky, Rolls-Royce, etc.

 If you are interested, please send all inquiries via email to jlee@vscnet.com. You can also visit our website at www.vscnet.com for more information on our company.

 Current Need:

-          Source Inspector (mechanical commodities) in Fort Lauderdale and Deerfield Beach, FL

-          Rate: Negotiable

-          Frequency: 2-3 days/week for one year

-          Position: Independent Contractor

Lucrative project opportunities for Six Sigma Black Belts in the South Florida area!!

 Seeking a dynamic professional for contractor Black Belt position with an emerging company www.aspirebusinessconsultingllc.com.  We’re looking for an individual with strong a understanding of Operational Efficiency and how it relates to the service industry.

 Description:

bulletUse six sigma tools to perform analysis on service-related and government-related projects impacting the economy and setting reporting requirements; working with private companies on major restructuring initiatives.
bulletIntroduce six sigma discipline and tools to members of both private and public organizations.
bullet Mentor , train and coach Green Belts on smaller, department-level projects using Six Sigma discipline.
bulletParticipate in the deployment of performance improvement methodologies.

 Requirements:

bulletKnowledge of Six Sigma methodology and tools.  Certification as a Six Sigma Black Belt.  Instructional design experience a plus!
bulletStrong leadership skills.  Ability to train, coach and motivate others, including business leaders, in Six Sigma tools and applications.
bulletStrong verbal and written communications skills, and ability to work across all levels in the organization.
bulletExperience working with process mapping and process analysis.
bulletDemonstrated experience in directing and managing large projects (influencing, driving and managing change).
bulletAbility to monitor progress of projects and formulate progress reports to distribute to clients.
bulletAbility to plan and implement structured management practices.
bulletProficiency with key PC software - Microsoft Office Suite, MS Project, Minitab.

 

Our clients rage from Industry leaders, to government agencies, business owners, and local board of directors members.  We offer competitive wages and the opportunity to positively impact the growth of our community.  Please send your resume to info@aspireconsultingllc.com

 

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