Seeking Regulatory Affairs and Quality System expertise in Medical Device manufacturing and a track record supporting and improving a quality and results driven company culture with excellent regulatory compliance and continually improving operations to support and coordinate registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and other activities.

Requires past experience creating, processing, reviewing, filing, validating and otherwise handling:

*** Nonconforming Material Reports and Rework Orders.

*** Corrective Action Reports (CAR’s).

*** Preventive Action Reports (PAR’s).

*** Process Change Orders (PCO’s).

*** Device History Records (DHR).

*** Mandatory Device Master Records (DMR).

*** Medical Device Adverse (MDA) and Field Corrective Actions (FCA) reports and recall notifications.

Activities:

*** Identifying, evaluating, and ensuring compliance with laws, regulations, and standards.

*** Ensuring quality of products through quality control tests and inspections and engineering change order support by applying design controls, risk management methods, and associated processes, policies and procedures.

*** Evangelizing the quality policyies and continual improvement.

*** Provide management with detailed review reports, official recommendations, and gap analyses for new and revised enactments.

*** Conduct supplier quaility management activities.

*** Coordinate and conduct internal and 3rd party quality audits. inspection activities (ISO, FDA, etc.)

*** Collecting, maintaining and reporting pertinent metrics.

*** Ensuring that reasonable risk management controls are in place.

*** Reviewing work and rework order fulfillment activities to ensure accurate and satisfactory completion.

*** Validating Engineering Change Requests and Orders to ensure sound engineering practice, effective and adequate design, product safety, and quality system compliance.

Generous compensation package with competitive salary and bonuses, company paid health and wellness benefits. Company matched 401(k), profit sharing, stock options, and pension. Vacation time from start with paid time off for personal days, sick days, and holidays. Upwards mobility and chance to directly impact the success and growth of the organization.

For details contact Patrick DiGangi at:
(609) 584-9000 ext 245

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

Or email to:
1000023882_10007339@jobbank301.com

Please reference #36838185 when responding.

2+ years

North Carolina

$75,000.00

$120,000.00

Patrick DiGangi

(609) 584-9000 ext 245

1000023882_10007339@jobbank301.com

http://dmc9.com/pjd/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 QA Quality Assurance Regulatory Affairs Quality Engineer ISO 13485 inhalers syringes implantable surgical insertable medical devices Catheters Guide Catheters Dialators Pusher Coils Stents Inducers Wire Forms Polymer Forms Woven Structures Cardio Defibrillators Pacemakers Implants Intra-Uterine Devices Tympanostomy Tubes

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