Company: Client of The Griffin Groupe Executive Search
Job Type: Full Time
Location: Oceanside, CA
Industry: Medical Equipment
Rate: $120-140K + Bonus + Benefits
Quality Assurance Manager
The Griffin Groupe is searching for talented quality professionals to join our client in the medical device manufacturing industry.
Responsible for implementation and enhancement of the Business (Quality) Management System and overseeing the Quality Department. Responsible for Document Control, corrective and preventive action, and design and development support in order to maintain and enhance compliance with ISO 13485, and regulatory requirements including acting as the PRRC (Person Responsible for Regulatory Compliance) Representative. This position reports directly to the President.
ISO 13485 Management Representative Role: Responsible for ensuring Business Management System (BMS) processes are established, implemented and maintained. Reports to Top Management on the performance of the BMS and suggestions for improvement. Ensures the promotion of awareness of customer and regulatory requirements. Schedules, coordinates and chairs Management Review. Acts as liaison with the Registrar.
REQUIRED EDUCATION & QUALIFICATIONS
- Provide BMS support, including the management of the Quality Assurance department. This includes the management of personnel and their activities, overseeing all stages of inspection: receiving, in- process, finished goods, returned goods.
- Oversee raw material and supplier quality, Document Control, corrective and preventive action, and design and development support in order to maintain and enhance compliance with ISO 13485 requirements.
- Key Auditor Trainer - provide in-house training and refresher training for the Internal Auditing group.
- Facilitate the corrective and preventive action program and assist the responsible parties as to the activities required to close the CAPA actions. Will also conduct verification audits to ensure that previous CAPA taken is closed and effective.
- Facilitate Management Review following completion of the internal audit and initiation of corrective and preventive action activities, develop the agenda, help correlated the data for presentation to Top Management, and initiate any corrective and preventive actions resulting from Management Review.
- High School diploma or some College or equivalent combined work experience and/or school experience.
- 3-5 years of direct medical device and /or manufacturing experience. Experience with receiving inspection plan development.
- Experience with sterile disposable products a plus
- Knowledgeable of FDA/QSR Quality System, ISO 13485 requirements and Medical Device Directives
- Works well in a fast paced, team environment
- Must have excellent communication skills (written & verbal)
- A quick learner and capable of being successful in achieving goals with limited supervision
- Resourceful, self-motivated.
- Good interpersonal skills, experienced in conflict resolution
The Griffin Groupe
Director of Recruiting and Technology
Please contact me with any questions: