Senior Supplier Quality Engineer

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.

• Set up acceptance activities, supplier audits, process validations, quality agreements negotiations, Supplier CAPAs, and 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

Responsibilities

• Ensure that suppliers deliver quality parts, materials, and services
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur through the Supplier CAPA process
• Develop and prioritize 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
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation
• 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
• Some individuals may have responsibilities that include Pre-Market Supplier Quality, with duties such as providing Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering, Post-Market Supplier Quality, and Distribution Teams to deliver quality parts, materials, and services, prevent defects, and allow MiniMed to provide customers with the highest quality and reliable products
• Define Receiving Inspection requirements as required and associated test method validation

Qualifications

• Bachelor of Technology

Pay

$80,000 - $100,000 a year

Benefits

• Discretionary Annual Incentive
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans
• Family Support: Maternal & Parental Leaves
• Insurance Options: Auto & Home Insurance, Identity Theft Protection
• Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement
• Time Off: Vacation, Time Off, Sick Leave & Holidays
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing

This response is AI-generated, for reference only.