Supplier Quality Engineer II

About the role

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.

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
• Provide 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
• Address 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

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 ISO 13485, 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

Qualifications

• 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

Pay

Salary Pay Range: $71,300.00 – $97,750.00 USD