Staff Supplier Quality Engineer

Wilson • Kalamazoo, MI

1d • Onsite

About The Position

We are seeking an experienced Staff Supplier Quality Engineer to support supplier quality engineering activities within a highly regulated environment. The Staff Supplier Quality Engineer will serve as a key liaison between suppliers and internal teams to drive supplier quality performance, continuous improvement, and quality system effectiveness. This role will support supplier quality issues, supplier audits, supplier performance evaluations, quality improvement projects, and supplier quality system assessments. The successful candidate will work closely with internal stakeholders, strategic sourcing, auditing, supplier development teams, and external suppliers to ensure supplier processes, quality systems, and performance meet quality and regulatory requirements.

Requirements

• Bachelor’s degree in Science, Engineering, or a related discipline preferred, or equivalent years of relevant experience.
• Minimum of 4 years of experience in quality, manufacturing, supplier quality, or a highly regulated environment.
• 3–5 years of experience in a regulated industry required, with preference for medical device, pharmaceutical, or automotive environments.
• 3–5 years of supplier-facing experience.
• Lead Quality Auditor qualification required, such as ISO 13485, 21 CFR Part 820, or a comparable standard/regulation.
• Strong written and verbal communication skills.
• Strong interpersonal, negotiation, and stakeholder management skills.
• Ability to represent the organization professionally during supplier visits and audits.
• Ability to travel for supplier audits, mostly short trips across the Midwest, sometimes with limited notice.
• Ability to work 40 hours per week.

Nice To Haves

• Active Lead Quality Auditor qualification strongly preferred; expired qualification may be considered with relevant recent audit experience.
• ASQ certification such as CQE, CMQ/OE, or PE.
• Lean Six Sigma Green Belt or Black Belt certification.
• Quality engineering experience.
• Experience using TrackWise.
• Working knowledge of FMEA, validation programs, and statistical process control.
• Knowledge of manufacturing processes, prints, tolerancing, statistics, and project management.
• Understanding of U.S. and international medical device regulations.
• Experience influencing supplier quality performance and driving supplier corrective actions.
• Experience supporting third-party audits or regulatory inspections.

Responsibilities

• Serve as a liaison between suppliers and internal teams to support supplier quality performance and continuous improvement.
• Support supplier quality issues by providing technical guidance, problem-solving support, and quality engineering expertise.
• Assess and critique supplier processes, control documentation, and quality management systems.
• Drive improvements within supplier quality management systems and supplier processes.
• Support tracking, reporting, and analysis of supplier performance KPIs and quality metrics.
• Articulate supplier performance results, trends, risks, and improvement opportunities to appropriate levels of management.
• Maintain and track completion of supplier action plans and corrective actions.
• Support supplier audits and quality system assessments.
• Participate in audits required by the organization, including supplier audits that may require travel.
• Provide support during third-party audits related to supplier quality engineering deliverables.
• Evaluate supplier compliance with applicable quality standards, regulatory requirements, and internal expectations.
• Collaborate with auditing and supplier development groups to understand supplier capabilities and competencies.
• Ensure supplier quality activities align with applicable medical device, regulatory, and quality system requirements.
• Propose and develop effective supplier quality improvement plans.
• Work with suppliers to implement corrective and preventive actions and drive sustainable improvements.
• Provide problem-solving expertise at company sites and supplier locations as needed.
• Identify and execute cost-reduction opportunities with suppliers.
• Transfer lessons learned from the supply base to internal teams for inclusion in future product designs and supplier strategies.
• Support quality improvement projects focused on supplier performance, process capability, and risk reduction.
• Partner with strategic sourcing, supplier development, auditing, engineering, quality, operations, and regulatory teams.
• Act as a single point of contact for strategic business partners and participate in supplier reviews as needed.
• Communicate effectively with suppliers and internal stakeholders at various levels of the organization.
• Represent the organization professionally during supplier visits, audits, and quality discussions.
• Support collaborative team-based work initially, with increasing autonomy once fully trained and aligned on key KPIs.
• Serve as a subject matter expert for assigned commodities or supplier quality areas.
• Share supplier quality expertise across the global organization.
• Serve as a process owner and support standardization of supplier quality-related processes.
• Train, mentor, and assist in the development of less experienced engineers.
• Work with a tenured team of supplier quality engineers and assigned mentors.
• Perform additional supplier quality engineering duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree