Quality Engineering Leader — Medical Devices Sustaining

Smith+Nephew; Mansfield (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Tuition Reimbursement

Parental Leave

Paid Holidays

Paid Time Off

Volunteer Time Off

Job summary

Smith+Nephew is seeking a Quality Engineering leader in Mansfield, MA to drive design quality across the product lifecycle. You will lead Sustaining Design Quality Engineers, oversee design controls, and partner with cross-functional teams to ensure safety, performance, and regulatory compliance for Joint Repair products.

The role emphasizes development of engineering talent, regulatory submissions support, and ongoing improvement of DHF and related quality deliverables in a highly regulated

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5+ years in medical device industry or similarly regulated environment.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.
• Proven leadership experience managing engineering teams.

Responsibilities

• Lead Sustaining Design Quality Engineers to support Joint Repair products.
• Drive product lifecycle management and resource allocation.
• Ensure robust design control practices and DHF integrity.
• Review and approve verification, validation, risk, CAPAs, and changes.
• Collaborate cross-functionally to meet safety, performance, and regulatory needs.
• Support regulatory submissions and participate in audits.
• Lead DHF assessments and drive continuous improvement.
• Provide technical leadership and mentor quality engineers.
• Influence stakeholders and resolve complex quality and technical challenges.

Skills

Leadership

Cross-functional collaboration

Design quality

FDA QSR knowledge

ISO 13485 knowledge

ISO 14971 knowledge

Mentorship

Regulatory submissions

Education

Bachelor of Science in Engineering

Job description

Smith+Nephew is seeking a Quality Engineering leader in Mansfield, MA to drive design quality across the product lifecycle. You will lead Sustaining Design Quality Engineers, oversee design controls, and partner with cross-functional teams to ensure safety, performance, and regulatory compliance for Joint Repair products.

The role emphasizes development of engineering talent, regulatory submissions support, and ongoing improvement of DHF and related quality deliverables in a highly regulated