Quality Engineering Senior

Senior Supplier Quality Engineer

Must have technical/functional skills: Senior Supplier Quality Engineer will support key projects and activities with critical suppliers in commodities such as injection molding, subassemblies, plastic, and other mechanical and electronic components. These activities may include set up acceptance activities, supplier audits, process validations, quality agreements negotiations, supplier CAPAs as well as supplier change requests (SCR) evaluations and dispositions. Strong hands on experience in supplier qualification, approval, and lifecycle management. Proven capability to create, manage, and maintain approved supplier lists (ASL). Experience conducting supplier quality system audits (on site/remote/desktop). Hands on experience leading or reviewing PPAP submissions for medical device components. Working knowledge of process validation requirements (IQ/OQ/PQ) for supplier processes. Strong understanding of risk based decision making aligned with ISO 14971 principles. Strong skills in root cause analysis and problem solving methodologies. Familiarity with electronic QMS/PLM systems (e.g., TrackWise, Agile, Windchill, SAP). Ability to work effectively with procurement, engineering, manufacturing, QA, and regulatory affairs. Strong supplier communication skills (technical discussions, expectations, escalation). Ability to manage multiple suppliers and PPAPs simultaneously in a regulated environment. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a certified supplier program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur through the supplier CAPA process. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

Roles & Responsibilities: Maintain and update the approved supplier list (ASL), including supplier addition, re approval, suspension, or disqualification. Conduct supplier evaluations including quality system assessments, technical capability reviews, and regulatory compliance checks. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and supplier quality requirements. Collaborate with procurement and operations to ensure only ASL approved suppliers are used for sourcing and production. Define PPAP scope and level based on component risk, regulatory impact, and supplier maturity. Act as the PPAP focal point for suppliers, ensuring timely and complete submission of PPAP packages. Ensure process validations (IQ/OQ/PQ) are completed when applicable for critical or special processes. Evaluate supplier change requests (SCRs) for quality, regulatory, and risk impact. Participate in root cause analysis, CAPA activities, and continuous improvement initiatives as required. Support readiness for internal, customer, and regulatory audits. Collaborate with manufacturing, engineering, and supplier quality teams to resolve quality issues in a timely manner.

Salary Range: $80,000 - $100,000 a year