Senior Quality Assurance Manager
IDj-42217
Job TypeDirect Hire
Remote TypeOn-Site
Compensation$1 - $2 / yr
Are you a Senior Quality Assurance Manager who wants to join a growing publicly held manufacturing company? Are you a Senior Quality Assurance Manager who has solid experience leading a Quality Management team in the medical device industry? If you can answer "yes" to these questions, you should consider this opportunity.
Our client has been in business since 1984 and is part of a Michigan-based publicly-held company. Our client is a prototype and custom manufacturer in the medical device space and business is strong! Our client is a leader in tooling and injection molding solutions for prototype, short run, and low to mid volume production applications. Our client has created a very employee friendly environment that fosters teamwork and respect. You will report to the President and will manage a team of 7 in a 3 shift custom injection molding manufacturing environment.
As Quality Assurance Manager you will:
- Be responsible for the strategic leadership, development, implementation, and maintenance of the Company's Quality Management System
- Ensure the effectiveness and compliance of the QMS to meet FDA 21 CFR Part 820, IS) 13485, and customer requirements client
- Identify deficiencies, corrective actions, and continuous improvement initiatives
- Collaborate with all levels of the organization to develop positive and proactive approaches to compliance activities
- Lead Management Review activities
- Serve as the Lead for external quality audits
- Lead the Nonconforming Material, CAPA, and Root Cause Investigation process
- Develop, manage, and continuously improve internal audit, supplier audit, and audit readiness programs
- Provide leadership for supplier quality management activities
- Provide leadership, coaching, and strategic direction to the Quality organization
As Quality Director your background should include:
- Bachelor's degree in Engineering, Quality Services, Biology, Physics, Chemistry or Math
- Minimum of 10 years of experience as a Sr. Quality Assurance Manager or related role in the medical device industry
- Strategic leadership skills
- Custom injection molding experience a plus
- Experience with ISO-13485 standards and 21CFR-820 regulatory compliance activity
- Track record of driving continuous improvement and reducing quality risks
- Solid experience leading supplier quality management activities
- Strong customer interaction skills
- Negotiating skills
- Development of Quality Plans and/or Control Plans
- Excellent oral and written communication skills.
Why should you consider this opportunity:
- To become an integral part of a growing custom medical device manufacturer that is part of an expanding Life Sciences Division of a very successful publicly held company.
- Excellent benefits package with medical benefits available on your start date.
Regional relocation assistance offered.
Complete job description available by request.