Remote Quality Engineer Medical Device Jobs in Michigan

Summary

The Supplier Quality Manager is a corporate-level quality leadership role responsible for developing, aligning and governing supplier quality processes across Aspen's global operations in a regulated medical device environment. This role owns the end-to-end supplier quality program from qualification and onboarding through performance management, auditing, and continuous improvement while managing a growing team of direct and indirect SQE’s.

This role is also directly accountable for finished goods supplier quality management and performance within the Caledonia, MI Distribution Center (DC).

In This Position, You Will Have the Opportunity To

Supplier Qualification & Onboarding

• Own and drive alignment of the global supplier qualification process, including quality system evaluations, capability assessments, and new suppliers approvals aligned with FDA’s QMSR, ISO 13485, and Aspen’s internal quality system.
• Support onboarding of new suppliers identified through organic growth, NPD programs, and M&A integrations — ensuring suppliers are qualified and production-ready on schedule.
• Maintain the Approved Supplier List (ASL) and ensure all documentation is current, accurate, and audit-ready.
• Making supplier selection decisions, providing quality input into sourcing strategies and make-versus-buy analyses.

Supplier Performance Management

• Establish and maintain supplier quality KPIs — including incoming product defect rates, supplier corrective action cycle time, on-time delivery, and overall supplier quality scores — and report performance to QA/RA, Supply Chain and Aspen leadership.
• Escalate critical supplier quality issues arising at international manufacturing, procurement, and distribution sites.
• Conduct regular supplier performance reviews, identifying underperforming suppliers and driving corrective action and improvement plans.
• Manage the Supplier Corrective Action Request (SCAR) process, ensuring root cause analyses are thorough, corrective actions are effective, and closure is timely. 
• Develop and maintain supplier scorecards and performance dashboards that provide clear, data-driven visibility into supplier quality across the enterprise.

 Supplier Auditing & Compliance

• Plan and execute a risk-based supplier audit program, conducting on-site and remote quality system audits across Aspen’s domestic and international supplier base.
• Lead audit activities against ISO 13485, FDA 21 CFR Part 820, and applicable regulatory standards, documenting findings and driving timely corrective action.
• Assess supplier quality management systems for adequacy, compliance, and continuous improvement orientation across the organization.
• Support internal and external regulatory inspections by ensuring supplier quality documentation and records are complete, accurate, and readily available.
• Monitor the regulatory landscape for changes impacting supplier quality requirements and ensure Aspen’s supplier quality program remains current and compliant.

Incoming Inspection & Material Quality

• Implementing non-conforming product identification and documentation process, ensuring that supplier issues and trends are acted upon and that critical issues are escalated and managing through to resolution and that suppliers are held accountable for restitution working with Supply Chain.
• Ensuring that inspection procedures, sampling plans, and acceptance criteria aligned with applicable standards and risk-based principles.
• Establish systems and documentation practices to adequately specify material requirements through specifications and drawings.

Change Management & NPD Support

• Support and lead supplier change notification processes that evaluate proposed changes from suppliers for quality and regulatory impact and ensuring appropriate review and approval prior to implementation.
• Support new product development programs that require qualifying new suppliers and components, participating in design reviews, and ensuring supplier quality requirements are incorporated into product specifications and support the process to help ensure that suppliers are ready at time of launch.
• Partner with NPD and Engineering on supplier selection for new products, providing quality input into material and component sourcing decisions.

M&A Integration Support

• Support M&A due diligence by assessing the supplier quality programs of acquisition targets, identifying risks and gaps that could impact deal valuation or integration complexity.
• Lead supplier quality integration activities for acquired businesses, including supplier qualification reviews, ASL consolidation, and alignment to Aspen’s quality system requirements.
• Partner with Supply Chain to rationalize and consolidate the supplier base where quality and supply continuity allow.

Continuous Improvement & Program Development

• Drive continuous improvement in supplier quality management systems and supplier performance across the enterprise, using data and root cause analysis to identify systemic issues and implement sustainable solutions.
• Develop, improve and harmonize Aspen’s supplier quality management procedures and supplier quality agreements to reflect best practices and evolving regulatory requirements.
• Build supplier quality capabilities through supplier development programs, training, and engagement that elevate the overall quality of Aspen’s supplier base where necessary and possible.
• Foster collaborative, trust-based relationships with key strategic suppliers that support long-term quality improvement and supply security.

What You Need to Succeed in This Position

• Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field required.
• Minimum of 7–10 years of quality experience in a medical device or regulated manufacturing environment, with at least 3–5 years in a supplier quality role.
• Strong working knowledge of FDA’s QMSR (Quality Management System Regulation), ISO 13485, and ISO 9001.
• Demonstrated experience conducting supplier audits, managing SCARs, and driving supplier performance improvement.
• Experience managing supplier qualification programs, Approved Supplier Lists, audit programs and supplier evaluation systems.
• Leadership experience includes both direct employee leadership and influential organizational leadership for site resources.
• Solid understanding of quality tools and methodologies including FMEA, root cause analysis, CAPA, control plans, and statistical sampling.
• Proven ability to manage multiple priorities simultaneously and drive cross-functional alignment in a fast-paced environment.
• Strong written and verbal communication skills with the ability to present quality data and supplier performance clearly and concisely to leadership.
• Up to 25% travel may be required, including domestic and international supplier visits and audits.

 Preferred Experience

• Experience in surgical products, single-use medical devices, or perioperative products strongly preferred.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
• Problem Solving and Data Analysis Skills or Certifications such as: Six Sigma Belt or Lean Manufacturing
• Experience supporting M&A supplier quality due diligence and post-acquisition integration.
• Familiarity with ERP systems and quality management software. 
• Experience managing international suppliers across multiple geographies including Mexico, Asia, and Europe.
• Working knowledge of EU MDR and other international regulatory standards.

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