Supplier Quality Engineer

Jobless; Plymouth (MN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical Insurance

Vision Insurance

Dental Insurance

Short-Term Disability

Life Insurance

401(k) match 50%

Paid vacation

Paid holidays

Job summary

SpiTrex CTE is seeking a supplier quality engineer to lead and maintain the organization’s supplier quality management program. You will develop and conduct supplier qualification, monitoring, and audits to ensure compliance with quality standards and regulatory requirements.

The role requires strong root cause analysis, project management, and cross-functional collaboration. This remote position offers flex scheduling and opportunities for professional growth within a medical device-focused

Qualifications

• A.S. in Engineering or 2+ years in Quality Engineering.
• Experience in Medical Device manufacturing preferred.
• 3–5 years in quality settings preferred.

Responsibilities

• Lead and maintain supplier quality management program in line with quality systems and regulatory requirements.
• Develop, implement, and maintain supplier qualification, approval, monitoring, and ongoing performance management processes.
• Conduct supplier risk assessments and develop mitigation strategies based on capability, quality history, criticality, and business risk.
• Lead supplier qualification, onboarding, evaluation, and approval activities with Procurement and internal stakeholders.
• Plan and conduct supplier quality audits and assessments to evaluate compliance with standards, procedures, and contractual requirements.
• Document supplier audit findings and work with suppliers to ensure timely resolution and effectiveness of actions.
• Manage supplier corrective action requests (SCARs), including investigation, root cause analysis, corrective action development, implementation, and verification.
• Investigate supplier-related quality concerns and coordinate containment, disposition, and corrective actions as needed.
• Provide technical support for supplier-related nonconformances and quality issues including root cause analysis.
• Review supplier change notifications to assess impact on product quality and regulatory requirements.
• Collaborate with internal teams to determine validation, qualification, inspection, or actions for supplier changes.
• Develop and maintain supplier scorecards and performance metrics across quality, delivery, responsiveness, and corrective actions.
• Analyze supplier quality data to identify recurring issues, risks, and improvement opportunities.
• Support supplier selection, qualification, and development activities with Procurement.
• Assist incoming quality inspection and receiving with guidance on supplier-related issues.
• Participate in cross-functional investigations, CAPA activities, and quality improvement projects.
• Prepare supplier quality reports and trend analyses for leadership review.
• Maintain relationships with suppliers and internal stakeholders to promote accountability and continuous improvement.
• Provide guidance on supplier quality requirements to internal teams.
• Support special projects and other duties as assigned.
• Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements.

Skills

Supplier quality management

Quality engineering

Root cause analysis

Project management

Cross-functional collaboration

Process improvement

Quality standards

Education

A.S. in Engineering

Job description

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