Seeking experience in a quality engineering role within a medical device manufacturing environment, or closely related with strict adherence to ISO 13485 and FDA regulations. Must have experience developing and implementing validation protocols for production processes and equipment.

Activities:

*** Oversee validation of manufacturing processes, cleaning processes, new equipment, laboratory instrumentation, software changes, etc.

*** Develop and review qualification and inspection processes and procedures.

*** Perform Installation Qualification, Operational Qualification, and Performance Qualification (IQ, OQ, PQ) procedures to ensure equipment and production processes meet customer and regulatory requirements.

Requires:

*** Experience in Quality Engineering for a plastic injection molding environment utilizing production processes such as: Machining, Plastic or Rubber Injection Molding, Laser Engraving, Assembly, Finishing, Cleaning, Sterilization, and Packaging.

*** Hands-on experience performing inspections of tooling, equipment, and products using metrology tools such as micrometers, calipers, gages, hardness testers, leak testers, visual inspection, CMMs, etc.

*** Thorough knowledge of FDA, ISO 13485, and other industry guidelines related specifically to Manufacturing Process Validation; Cleaning Validation; Equipment, Facilities and Utilities Validation; Laboratory Equipment Validation; and Control Systems Software Validation.

Exciting opportunity to join an award winning, rapidly growing medical device manufacturer with capabilities including advanced mold design, part prototyping, and clean-room manufacturing. Competitive compensation package with generous base salary, competitive bonus, generous benefits package (medical, dental, vision, life insurance, short and long-term disability, 401(k) with match), flexible spending account, and paid time off for vacations.

For complete details contact James A. Lockley, LT USN (Ret) at:
(609) 584-9000 ext 278

Or, submit resume online at:
http://dmc9.com/jal/app.asp

Or email to:
1000022964_10007183@jobbank301.com

Please reference #36730141 when responding.

2+ years

New Jersey

$80,000.00

$120,000.00

James A. Lockley, LT USN (Ret)

(609) 584-9000 ext 278

1000022964_10007183@jobbank301.com

http://dmc9.com/jal/app.asp

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Quality Engineer Reliability Engineer Manufacturing Engineer Process Engineer Project Engineer Manufacture Engineering Tools Tooling Engineer Product Engineer Injection Mold Plastics Assembly Automotive Six Sigma Black Belt Green Belt American Society Quality ASQ ISO 13485 Advanced Product Quality Planning APQP Production Part Approval Process PPAP Failure Mode Effects Analysis FMEA Corrective And Preventative Action CAPA

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