Quality Assurance Medical Devices IVD - Philadelphia, PA

Compliance Engineer Quality Engineer Manager Quality Assurance Director Medical Diagnostic Devices Laboratory Instrumentation Biologics Biopharm ISO 14971 Risk Management Medical Devices ICH Q9 IVD _ .

Exciting opportunity for an experienced Quality Assurance Professional with background in Diagnostic Medical Device manufacturing to join a worldwide leader in devices found in hospitals, research laboratories, and other life sciences facilities.

Activities:

*** Review product designs for quality and risk management requirements defined by ISO 14971, ISO 13485, and FDA regulations.

*** Recommend and implement changes to product designs.

*** Ensure product compliance to safety standards, compatibility (example: Electromagnetic Compatibility), and diagnostic medical device requirements by working with design engineers to revise and implement improvements to product designs.

*** Maintain Device Master Record (DMR) and Design History File (DHF) files.

*** Maintain QMS (Quality Management System) according to ISO 13485 standards.

*** Ensure adherence to FDA QSR (Quality System Regulation) compliant with current good manufacturing practices (CGMP).

Requires:

*** Experience with diagnostic medical device or similar laboratory instrumentation manufacturing.

*** Experience working with a range of internal teams including design, manufacturing, quality assurance, and regulatory affairs - must be able to communicate complex concepts in a concise, accurate manner.

Potential total compensation package up to $160,000 including competitive benefits for full family - including medical, dental, eyeglasses and contacts, prescription drugs, specialist visits, and more. Work in a state of the art facility in a growing industry leader with plants in the US and over 10 other countries!

For complete details contact Christopher Moreno at:
(609) 584-9000 ext 264

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

Or email to:
1000055980_10007349@najbcareers303.com

Please reference #42721642 when responding.

5+ years

Pennsylvania

$100,000.00

$160,000.00

Christopher Moreno

(609) 584-9000 ext 264

1000055980_10007349@najbcareers303.com

https://dmc9.com/cam/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 Compliance Engineer Quality Engineer Manager Quality Assurance Director Medical Diagnostic Devices Laboratory Instrumentation Biologics Biopharm ISO 14971 Risk Management Medical Devices ICH Q9 IVD #DiedreMoire #JobSearch #JobHunt #JobOpening #Hiring #Job #Jobs #Careers #Employment #jobposting #qualityjobs #medicaldevicejobs #QualityManager

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