Senior Quality Engineer: Shape Patient Care & Compliance

Integra LifeSciences Corporation; Mansfield (MA); On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences Corp. is hiring a Senior Quality Engineer in Mansfield, MA to lead quality initiatives across the product lifecycle. You will analyze processes, manage non-conformances, and support audits to ensure ISO-13485 and CFR 820 compliance.

Ideal candidates have 5+ years in quality engineering, strong regulatory knowledge, and experience with IQ/OQ/PQ and TrackWise in a regulated medical device setting.

Qualifications

• Engineering or technical degree with 5+ years of experience, or advanced degree with related experience.
• Excellent organizational and English communication skills (oral & written).
• Familiarity with ERP systems (Oracle ideal).
• Experience in regulated environments; medical device or pharma preferred.
• Experience writing IQ/OQ/PQ documents and using QMS tools.

Responsibilities

• Support quality improvement initiatives and process characterizations.
• Work on non-conforming reports and root-cause investigations.
• Conduct internal and supplier audits per ISO-13485/21 CFR 820.
• Develop monitoring/control methods and perform data analysis.
• Own material identification, defect classification, and CAPA reviews.
• Plan and review validation activities; mentor engineers and technicians.

Skills

Quality Engineering

Problem solving

Communication

Regulatory knowledge

Team collaboration

Education

Bachelor’s or Master’s in Engineering

Tools

IQ/OQ/PQ

TrackWise

MS Office

ERP (Oracle)

Job description

Integra LifeSciences Corp. is hiring a Senior Quality Engineer in Mansfield, MA to lead quality initiatives across the product lifecycle. You will analyze processes, manage non-conformances, and support audits to ensure ISO-13485 and CFR 820 compliance.

Ideal candidates have 5+ years in quality engineering, strong regulatory knowledge, and experience with IQ/OQ/PQ and TrackWise in a regulated medical device setting.