Are you a quality leader passionate about driving excellence across the full product lifecycle? This is an opportunity to lead a high performing engineering team, influence strategic initiatives, and ensure life enhancing medical technologies remain safe, effective, and compliant. Based in Mansfield, MA, you will play a critical role in sustaining innovation while shaping quality practices across the organization.
What will you be doing?
Leading a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle
Driving product lifecycle management initiatives and strategically allocating resources to meet business needs
Ensuring robust and compliant design control practices, maintaining Design History File integrity
Reviewing and approving key quality deliverables including verification and validation, risk management, CAPAs, and design changes
Partnering with cross functional teams to ensure products meet safety, performance, and regulatory requirements
Supporting regulatory submissions and representing design control activities during audits
Leading DHF assessments and conducting gap analyses to drive compliance and continuous improvement
Providing technical leadership and mentorship to develop quality engineering talent
Influencing stakeholders and resolving complex quality, technical, and operational challenges.
What will you need to be successful?
Bachelor of Science in Engineering or a related technical field
5+ years of experience in the medical device industry or a similarly regulated environment
Strong knowledge of FDA QSR, ISO 13485, and ISO 14971
Proven leadership experience managing and developing engineering teams
Ability to collaborate cross functionally and communicate effectively at all levels
Experience driving design control activities and solving complex quality challenges
CQE or Lead Auditor certification preferred
The anticipated base compensation range for this position is $xxxx000.00 to $xxxxx.00 USD annually.
The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.
In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.
#LI-HYBRID
