A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. We value what makes you unique. 

In this exciting role as a Quality System s Manager, you will manage and mentor a staff of 4 Quality Engineers, in the support for production needs for the Medtronic Osteotech site in Eatontown, NJ. You will have responsibility to lead several Quality site programs and support implementation of projects and activities to define, design, develop and deliver quality improvement, and change initiatives while meeting all applicable regulatory requirements. This role will support Manufacturing Operations, the site Laboratories, and Operational Excellence requests and report to the Site Quality Leader.

A key responsibility is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals. The person in this role will also be involved in all regulatory audits at the site.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

• Bachelors degree required
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

• Management experience preferred.
• Tissue Processing/Bank experience preferred.
• Auditing experience (front/back room) 
• CAPA and NCMR experience essential.
• ASQ Quality Engineer Certification preferred
• Previous Medical Device experience is helpful.
• DMAIC Lean / Six Sigma Certification.
• Black Belt or Master Black Belt – Design for Six Sigma (DFSS) / DRM or similar methodology.
• Experience in the application of statistical methods for improvements in product performance
• Manufacturing Management experience within a controlled and regulated industry.
• Experience leading large-scale change management.

A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. 

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.