Supplier Quality Engineer II

Integra LifeSciences•Mansfield, MA

4d•$71,300 - $97,750

About The Position

This Supplier Quality Engineer II role serves as a key quality representative supporting contract manufacturers and raw material suppliers involved in the production of Integra products. The position is responsible for supplier audits, supplier performance monitoring, CAPA and nonconformance management, supplier change control, quality agreement management, and validation activities while ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory requirements. The ideal candidate will have experience working in a regulated medical device or life sciences environment and possess a strong understanding of supplier quality systems, root cause investigations, and quality engineering principles. This role partners closely with Quality Control, Manufacturing, Purchasing, and supplier organizations to drive continuous improvement, resolve quality issues, and ensure supplier compliance. It is an excellent opportunity for a quality professional looking to influence supplier performance, support business continuity, and contribute to the delivery of safe and effective medical products.

Requirements

A minimum of a Bachelor’s Degree in an Engineering, Life Science, or a related technical discipline. Candidates with an equivalent combination of education and experience will also be considered for the position.
Minimum 3 years of professional work experience in a GMP and /or ISO regulated industry.
Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820.
Strong communication, teamwork, and organizational skills are essential
Strong analytical problem solving and root cause analysis skills
Use of ERP, PLM systems
Use of Microsoft office tools
Knowledge of statistical techniques

Nice To Haves

Experience working in a Medical Device or Life Science manufacturing environment.
Operations supplier quality experience, with a strong understanding of process validation (IQ, OQ, PQ).
Auditor Certification to ISO 13485:2016.
Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly.

Responsibilities

Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products
Establishes and ensures the Approved Supplier List is up to date
Establishes timely planning and execution of supplier audits
Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products
Report on contract manufacturer performance metrics
Ensure technical support to QC, purchasing and production departments
Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.
Addresses Supplier Change Requests in compliance with procedures and regulatory requirements
Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline
Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions
Manages or participates in quality projects as required
Provides support with complaint investigations as required