Sustaining Quality Engineering Manager – Medical Devices

Smith & Nephew; Mansfield (MA); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

401(k) Matching Program

Tuition Reimbursement

Medical, Dental, Vision coverage

Job summary

Smith+Naphew in Mansfield, MA seeks a quality leader to guide a Sustaining Design Quality Engineering team. You will influence lifecycle quality programs, maintain robust design controls, and drive compliance across the full product lifecycle.

You will lead cross-functional collaborations, oversee verification/validation, risk management, CAPAs, and design changes, and mentor engineers to elevate quality practices while supporting regulatory activities and audits.

Qualifications

• Bachelor of Science in Engineering or related field.
• 5+ years in medical device or regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971.
• Proven leadership experience managing and developing engineering teams.
• Ability to collaborate cross functionally and communicate effectively at all levels.
• CQE or Lead Auditor certification preferred.

Responsibilities

• Lead a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle.
• Drive product lifecycle management initiatives and strategically allocate resources to meet business needs.
• Ensure robust and compliant design control practices, maintaining Design History File integrity.
• Reviewing and approving 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.

Skills

Leadership

Quality engineering

Regulatory knowledge

Cross-functional collaboration

Mentorship

Education

Bachelor of Science in Engineering

Job description

Smith+Naphew in Mansfield, MA seeks a quality leader to guide a Sustaining Design Quality Engineering team. You will influence lifecycle quality programs, maintain robust design controls, and drive compliance across the full product lifecycle.

You will lead cross-functional collaborations, oversee verification/validation, risk management, CAPAs, and design changes, and mentor engineers to elevate quality practices while supporting regulatory activities and audits.