Remote Supplier Quality Engineer - Quality & Compliance

Jobless; Plymouth (MN); Hybrid; 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

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