Medical Device Quality Manager
24401 Capital Boulevard Clinton Twp, MI 48036
Title: Medical Quality Manager
Location: Clinton Twp, MI
MEDICAL DEVICE QUALITY MANAGER:
We are looking for an experienced Medical Device Quality Manager, reporting to the President, that would be responsible for leading a team of Quality professionals dedicated to ensuring our products meet the highest quality, and under the requirements of FDA, 21CFR-820 and ISO13485.
The exceptional candidate MUST HAVE MEDICAL DEVICE experience; and will either be willing to relocate or be local to the Clinton Township, MI area, be authorized to work in the US, and possess the leadership skills that inspires employees to be their best on behalf of the success of he customers we serve.
For the Quality Manager some of the criteria:
- Manage the Quality Engineering staff
- Prefer BS degree in scientific discipline (Biomedical, Mechanical, Life Sciences, Chemical
- 3-5 years with at least 2 in supervisory capacity
- CQE or CQM
- In depth knowledge of IQ/OQ/PQ requirements, Validation, Risk Analysis (FMEA), statistical analysis, sampling plans & theory, FDA QSRs and ISO 13485 regualtions, protocol, report writing and development of processes with the knowledge of FDA, 21CFR820 and ISO13485 requirements
- A minimum of 5 years’ experience managing and developing a team of medical device component manufacturing professionals, and ensuring that the required training and development of those direct report employees is completed effectively;
- Proven experience with developing and ensuring compliance within a QMS specific to medical device, FDA, ISO13485, ISO14971, ISO14644 and 21CFR-820, with experience developing the necessary training to all manufacturing teams to support these requirements;
- Proven skills in protocol and technical writing as well as executing training programs in support of our QMS;
- Provide leadership in developing and executing Internal Quality Audits, 3rd Party Audits, CAPAs, Management Review, Calibration, Validation, Document Control, Risk Management, Quality Planning and Nonconforming Material, GMP and GDP;
- Provide the experience to assist management teams and manufacturing operations to ensure compliance in all areas of medical device requirements, processes and procedures;
- Experience with IQ, OQ and PQ, and DHF / DMR / DHR;
- Leaderships skills in analyzing and providing QMS metrics, and developing recommendations based upon those metrics;
- Strong organizational, interpersonal, leadership, oral/written communication, and computer skills a must.