Job ID: 211481435

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

MEDICAL DEVICE MANUFACTURING 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 Manufacturing Manager, reporting to the Director of Operations, that would be responsible for the overall medical injection molding manufacturing client experience from the time the project is introduced at APQP through final part or assembly shipment.  The ideal candidate would be responsible for the overall success and development of Omega’s validated manufacturing medical operations’ team, which includes all resources utilized to develop repeatable processes, medical molded parts and assemblies in a compliant, safe, productive and profitable environment.  Provides the strategic development and evolution of medical device manufacturing including development of volume production and assembly processes; and 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 Omega Plastics as well as the customers we serve.

Primary Requirements:

·         10+ years’ experience in a senior management role.

·         7+ years’ experience with Quality systems such as ISO9001, ISO13485, ISO14971 and FDA, 21CFR-820.

·         5+ years’ experience in demand planning and finite scheduling in high-mix, low-volume medical device production environment

·         3+ years’ Cleanroom /medical experience (including IQ, OQ, PQ) and DHF / DMR / DHR highly desired.

·         5+ years’ experience with medical assembly operations desired.

·         Must understand and adhere to good GMP and GDP practices, and understand the regulatory compliance associated with the medical device industry.

 

Specific Responsibilities:

 

·         Provide development and leadership of the medical injection molding and assembly operations including direct oversight of those disciplines that fall within the medical molding/scheduling, process/manufacturing engineer, maintenance and facilities, purchasing, shipping/receiving, and warehouse.

·         Assuring that appropriate systems and structure are in place to produce acceptable medical device product that is packaged correctly to GMP and GDP standards.

·         Personnel development of direct reports-- includes staffing recommendations, training, and APDA (associate development reviews).

·         Taking appropriate action to improve Key Metrics (On-time delivery, gross margin, and cost of waste).  Ensure that team provides reporting of metrics required for improvement.

·         Coordinate with quality manager (who reports to the President) and quality team to ensure quality levels of product meet expectations and to support CAPA’s.

·         Customer Representative:  Along with designated others, has the responsibility and authority to ensure that customer requirements are addressed. 

·         Accountable for development and leading the implementation of an annual medical operations plan, including an emphasis on structure, roles, automation of higher volume medical manufacturing and assembly including all auxiliary equipment needed for effective manufacturing.

·         Assures inventory accuracy

·         Departmental compliance to Omega BQMS.

·         Safety of manufacturing work environment (compliant with state & federal requirements)

·         Attend, or have a qualified team member attend, client meetings to review projects that are expected to have a significant financial impact to Omega.

·         Provide plant layout and execute effective planning and implementation of the medical manufacturing.

·         Driver for innovation and advanced technologies in manufacturing and assembly.

·         Execute layered process audit

·         Train team on lean, 5s, and appropriate best-in-class medical manufacturing processes that adhere to FDA regulations and ISO13485 requirements to cultivate an environment of continuous improvement.

·         Determine and/or drive completion of medical manufacturing initiatives as set forth in quarterly and annual operating and manufacturing plans.

·         Determine and manage manufacturing outsources.

·         Other specified duties as required by the Director of Operations and engineering requirements.

 

 

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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