Supplier Quality Engineer II - Medical Devices

Integra-Lifesciences; Mansfield (MA); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

Short- & long-term disability

401(k) savings plan

Job summary

Integra LifeSciences is seeking a Supplier Quality Engineer II in Mansfield, MA. You will lead supplier audits and ensure ongoing supplier quality, maintain quality agreements, and drive CAPA, change control, and validation activities to meet FDA 21 CFR Part 820 and ISO 13485 standards.

You’ll collaborate with Quality Control, Manufacturing, Purchasing, and supplier networks to improve performance, support business continuity, and ensure safe, compliant medical products.

Qualifications

• Bachelor’s degree in Engineering, Life Science, or related technical discipline required or equivalent experience.
• Minimum 3 years of professional experience in a GMP/ISO regulated environment.
• Knowledge of ISO13485, 93/42 EEC, and 21 CFR Part 820 regulations.
• Strong communication, teamwork, and organizational skills.
• Experience with ERP/PLM systems and statistical techniques.

Responsibilities

• Provide QA leadership to select contract manufacturing sites and raw material suppliers producing Integra products.
• Maintain and update the Approved Supplier List.
• Plan and execute supplier audits in a timely manner.
• Conduct supplier audits per GMP/ISO/regulatory requirements.
• Maintain Supplier Quality Agreements for applicable suppliers.
• Report on supplier performance metrics.
• Provide technical support to QC, purchasing, and production teams.
• Support suppliers with audits, inspections, validation, CAPA, and change management per CFR 820 and ISO 13485.
• Address Supplier Change Requests per procedures and regulatory requirements.
• Ensure outsourcing validation activities are performed and documented on time.
• Initiate, disposition, and investigate supplier non-conformances and close out per plans.
• Escalate supplier quality issues and propose robust solutions.
• Participate in quality projects as needed.
• Assist with complaint investigations as required.

Skills

Supplier audits

Supplier performance

CAPA & nonconformance

Change control

Quality agreements

Validation activities

Regulatory compliance

Root cause analysis

ERP

PLM

Microsoft Office

Statistical techniques

Education

Bachelor’s degree in Engineering/Life Science/related technical discipline

Tools

ERP systems

PLM systems

Microsoft Office

Job description

Integra LifeSciences is seeking a Supplier Quality Engineer II in Mansfield, MA. You will lead supplier audits and ensure ongoing supplier quality, maintain quality agreements, and drive CAPA, change control, and validation activities to meet FDA 21 CFR Part 820 and ISO 13485 standards.

You’ll collaborate with Quality Control, Manufacturing, Purchasing, and supplier networks to improve performance, support business continuity, and ensure safe, compliant medical products.