Job ID: 209831107

Job Summary
Employment Type
Full Time
Years Experience
5 - 10 years
Job Description

MEDICAL DEVICE QUALITY MANAGER

Omega Plastics, Inc., located in Clinton Township, MI, has been in business for over 35 years, and is a leader in tooling and injection molding solutions for diversified prototype and low/mid volume production within the medical, defense/aerospace, and consumer markets.  With nearly 80% of our business in the medical device industry, this is an opportunity to grow with us while making a difference in other people’s lives!  You would be joining a team of innovative, collaborative and experienced individuals within our growing company.

Currently, 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 experience with medical device manufacturing, 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 Omega Plastics as well as the customers we serve.

Primary 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.

 

Omega Plastics, Inc. offers an exceptional compensation and benefits package, with relocation reimbursement for the right-fit candidate!  Some of the perks of the position include an exceptional team environment, caring/family culture within a growing company, and an opportunity to contribute as a testament of your career successes!

 

Omega Plastics, Inc. is an EEO Employer.

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COMPANY OVERVIEW

Omega Plastics, Inc.

Omega Plastics, Inc., located in Clinton Township, MI, has been in business for over 35 years, and is a leader in tooling and injection molding solutions for diversified prototype and low/mid volume production within the medical, defense/aerospace, and consumer markets. With nearly 80% of our business in the medical device industry, this is an...
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Website:

http://www.opinc.com

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