Medical Device Quality Systems Manager

Anaheim, CA

Job ID: 122577 Industry: Med


Medical Device Quality Systems Manager

Environment:

Our client is in the medical device field.  They are currently in need of a Quality System Manager who is comfortable with hands on work as well.  Our client is doing work on their quality systems and needs some guidance on how to help their processes.

Responsibilities:

The Quality Systems Manager is responsible for setting direction, coordination, and timely completion of day to day activities in the Quality Systems department. Establishes monthly Quality Performance Indicators, provides quality reports, and trend analysis to Management.  Develops procedures and controls to ensure the Internal Audits, Supplier Audits, Document Control, and CAPA system is operating according to the client’ s requirements.  Develops quality system SOPs. Strong Hands-on experience with 21CFR part 820 with a solid practical experience in Design Controls, strong knowledge and experience with ISO 13485 and ISO 14971, and experience with leading and performing CAPAs. The need to be able to effectively work cross-functionally with R&D, and Operations. Candidate must be results oriented, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines. Good interpersonal and communication skills.

 

Required:

Medical Device- 10 years

Quality Systems- 10 years

CAPAs

ISO 13485 and ISO 14971

Engineering Bachelor Degree

Job Type: Contract 

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