Supplier Quality Engineer

About the role

This position is fully remote and follows a 1st shift schedule: Monday to Thursday, 6:30 AM - 3:30 PM; Friday, 6:30 AM - 10:30 AM.

Responsibilities

• 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.
• Perform other work-related tasks as assigned.

Requirements

• 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.

Qualifications

• A.S. in Engineering field preferred or minimum of 2 years in a Quality Engineering role.
• 3–5 years of experience in a Quality setting preferred.
• Medical device manufacturing experience preferred.

Benefits

• Medical, Vision, and Dental Insurance (no-cost vision, life, and short-term disability; dental & medical with HSA or PPO options).
• Short-Term Disability and Life Insurance.
• 401(k) with 50% company match (up to 10% contribution).
• Paid vacation days and holidays.
• Referral bonuses and quarterly bonuses.
• Ongoing training and development through Bamboo Path Track & Litmos.
• Flextime options.
• Team events, Donut Fridays, and food trucks.

Schedule

1st Shift: Monday to Thursday, 6:30 AM - 3:30 PM; Friday, 6:30 AM - 10:30 AM.