Supplier Quality Engineer

Build More Than a Job—Build a Career at SpiTrex CTE At SpiTrex CTE, we invest in our people. You’ll find opportunities to grow, real flexibility, and a culture that values balance, development, and teamwork. Why join CTE? Career Growth: Ongoing training and development through Bamboo Path Track & Litmos Flexibility: Flextime options that support real life Culture: Team events, Donut Fridays, food trucks, and more Rewards: Referral bonuses, quarterly bonuses, and a 401(k) with 50% company match (up to 10%) Benefits: No-cost vision, life, and short-term disability; dental & medical with HSA or PPO options Ready to grow with a company that values you? Join SpiTrex CTE. This position would be able to work remotely. 1st Shift: Monday to Thursday, 6:30AM - 3:30PM; Friday, 6:30AM - 10:30AM Essential Functions: Lead and maintain the organization's supplier quality management program in alignment with applicable quality system and regulatory requirements. Develop, implement, and maintain processes for supplier qualification, approval, monitoring, and ongoing performance management. Conduct supplier risk assessments and develop appropriate mitigation strategies based on supplier capability, quality history, criticality, and business risk. Lead supplier qualification, onboarding, evaluation, and approval activities in partnership with Procurement and internal stakeholders. Plan and conduct supplier quality audits and assessments to evaluate compliance with applicable quality standards, specifications, procedures, and contractual requirements. Document supplier audit findings and work with suppliers and internal stakeholders to ensure timely and effective resolution. Manage supplier corrective action requests (SCARs), including investigation, root cause analysis, corrective action development, implementation, and verification of effectiveness. Investigate supplier-related quality concerns and coordinate appropriate containment, disposition, and corrective action activities. Provide technical support for supplier-related nonconformances, defects, and quality issues, including root cause and problem-solving activities. Review and assess supplier change notifications to determine potential impacts to product quality, manufacturing processes, regulatory requirements, and business operations. Collaborate with internal Quality and Engineering teams to determine appropriate validation, qualification, inspection, or other actions associated with supplier changes. Develop and maintain supplier scorecards and performance metrics, including quality, delivery, responsiveness, corrective action, and other applicable measures. Analyze supplier quality data and trends to identify recurring issues, emerging risks, and opportunities for improvement. Partner with Procurement on supplier selection, qualification, performance evaluations, and supplier development activities. Support incoming quality inspection and receiving functions by providing technical guidance and problem-solving assistance for supplier-related issues. Participate in cross-functional investigations, CAPA activities, continuous improvement initiatives, and quality improvement projects. Prepare supplier quality reports, metrics, and trend analyses for leadership and management review. Establish and maintain effective working relationships with suppliers and internal stakeholders to promote accountability, communication, and continuous improvement. Provide guidance and technical support to internal teams regarding supplier quality requirements and expectations. Support special projects, strategic quality initiatives, and other duties as assigned Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements Other work-related tasks as assigned Competency: Strong knowledge of supplier quality management principles and quality engineering practices. Strong analytical and problem-solving skills with the ability to identify root causes and develop sustainable solutions. Ability to interpret engineering drawings, specifications, inspection requirements, and other technical documentation. Ability to effectively assess supplier capability, process controls, and quality risks. Strong project management and organizational skills. Ability to influence and collaborate across functional teams without direct authority. Strong interpersonal and relationship-building skills with both internal and external stakeholders. Ability to communicate complex technical and quality requirements clearly and effectively. Demonstrated attention to detail and commitment to product quality and customer requirements. Proficiency with Microsoft Office applications and quality management systems. Educational Requirements: A.S. in Engineering field preferred or minimum of 2 years in Quality Engineering role Experience: Medical Device manufacturing preferred 3 – 5 years of experience in Quality setting preferred Benefits Include: Medical, Vision and Dental Insurance Short-Term Disability Life Insurance 401(k) - 50% company match (up to 10% contribution) Paid vacation days Paid holidays