Supplier Quality Engineer

Job Description

Job Description

SUPPLIER QUALITY ENGINEER

Job Description

Who We Are:

Marketlab is a market leading healthcare solutions organization specializing in the design, manufacturing, and sourcing of private label products. It’s our mission to provide our healthcare partners timely solutions with a straightforward approach based on knowing them and their work. Every day we strive to positively impact the lives of the people who in turn impact the health and wellness of our communities. Based in Grand Rapids, Michigan, Marketlab’s success is built upon a foundation of collaboration, innovation, and the belief that every team member plays a vital role in creating an exceptional customer service experience.

The Opportunity:

The Supplier Quality Engineer (SQE) is responsible for ensuring suppliers consistently meet Marketlab’s quality, regulatory, technical, and performance requirements. This position serves as the primary Quality interface with suppliers and works cross-functionally with Engineering, Product Development, Supply Chain, Manufacturing, and Regulatory Affairs to establish appropriate supplier and product controls. The Supplier Quality Engineer is responsible for supplier qualification and monitoring, supplier audits, incoming quality controls, nonconforming material investigations, supplier corrective actions, product specifications, risk management, and continuous improvement activities. This role also provides Quality Engineering support for new and existing products to ensure supplier-manufactured products meet defined specifications and applicable Quality Management System requirements. This role reports to: Quality and Regulatory Manager

Functional/Technical Competencies:

• Quality Focus – Demonstrates a strong commitment to product quality and consistently applies risk-based thinking when evaluating supplier and product issues.
• Technical Expertise – Applies Quality Engineering principles, statistical methods, inspection techniques, and manufacturing knowledge to supplier and product quality issues.
• Supplier Management – Establishes productive supplier relationships while maintaining clear expectations and accountability for quality performance.
• Decision Making – Uses objective evidence, risk, technical requirements, and quality data to make sound decisions regarding supplier and product quality.
• Continuous Improvement – Identifies opportunities to improve supplier capability, reduce defects, strengthen controls, and improve Quality System effectiveness.

Behavioral Competencies:

• Business Acumen – Understands the business implications of supplier quality decisions and balances quality, regulatory, customer, operational, and business requirements.
• Problem Solving – Identifies and analyzes complex quality problems, determines root cause, and develops effective and sustainable corrective actions.
• Leadership and Coaching – Provides clear direction, technical guidance, feedback, and support to direct reports while promoting accountability and professional development.
• Communication – Communicates technical and quality requirements clearly and effectively with suppliers, Engineering, Operations, management, and international team members.
• Quality of Work – Accepts responsibility for the accuracy, completeness, and timeliness of work and maintains appropriate documentation.
• Teamwork – Collaborates effectively with Engineering, Product Development, Supply Chain, Manufacturing, Regulatory Affairs, and suppliers to achieve business and quality objectives.

What You’ll Do:

• Manage the supplier quality lifecycle, including qualification, approval, monitoring, reevaluation, and disqualification, based on product risk, supplier capabilities, certifications, regulatory status, and quality performance.
• Conduct supplier audits and assessments, establish quality requirements and agreements, and build productive supplier relationships with clear expectations and accountability.
• Monitor defect rates, nonconformances, complaints, corrective actions, inspection results, and delivery performance. Analyze trends to identify improvement opportunities.
• Lead supplier quality and nonconforming material investigations, support complaint investigations, and assess potential systemic impacts across products, lots, and product families. Collaborate with Engineering and other functions on product disposition.
• Manage Supplier Corrective Action Requests (SCARs) and support CAPA activities, partnering with suppliers to identify root causes, implement sustainable corrective and preventive actions, and verify effectiveness.
• Develop and maintain risk based incoming inspection requirements, sampling plans, inspection methods, and acceptance criteria. Work with suppliers to establish effective process controls and control plans.
• Review product specifications, drawings, bills of material, and inspection criteria. Partner with Design and Product Engineering to identify Critical to Quality (CTQ) characteristics and establish appropriate supplier controls.
• Participate in supplier selection, design transfer, new product introduction, and product changes. Support verification and validation of supplier manufactured products, and review and approve supplier changes affecting materials, processes, manufacturing locations, tooling, specifications, or product quality.
• Evaluate supplier manufacturing processes and capability using statistical analysis, capability analysis, sampling techniques, measurement system analysis, and root cause analysis. Support process qualification and validation, including IQ/OQ/PQ, where applicable.
• Participate in product and process risk management, including risk assessments and Process FMEAs, and support continuous improvement projects that reduce defects, strengthen supplier capability, and lower quality related costs.
• Maintain accurate supplier quality records within Marketlab’s Quality Management System. Support compliance with ISO 13485, ISO 9001, FDA Quality Management System requirements, and other applicable regulations, along with internal, customer, supplier, and regulatory audits.
• Coordinate supplier quality activities involving Asia based suppliers, including audits, inspections, corrective actions, process reviews, and follow up. Maintain alignment with Marketlab’s U.S. teams and ensure timely escalation of significant issues.
• Travel to supplier locations for audits, investigations, process reviews, qualifications, and improvement activities, and complete other projects as directed by Quality Management.

The ideal candidate will have:

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field.
• Three to five years of experience in Supplier Quality, Quality Engineering, Manufacturing
• Engineering, or a related quality function preferred.
• Experience working directly with Asia-based suppliers is required, including supplier
• qualification, quality issue resolution, corrective actions, and ongoing supplier
• performance management.
• Experience conducting supplier audits and working with manufacturing partners in
• China and other Asian countries strongly preferred.
• Experience working with and providing direction to international or remotely based
• employees or quality personnel strongly preferred.
• Demonstrated ability to effectively manage supplier quality activities across time zones,
• language differences, and cultural and business practices.
• Experience working in a regulated manufacturing environment is preferred. Medical
• device experience is highly desirable.
• Working knowledge of ISO 13485, ISO 9001, FDA Quality Management System
• requirements, and supplier quality management principles.
• Experience with supplier corrective actions, nonconforming material, CAPA, root cause
• analysis, and corrective action methodologies.
• Experience interpreting engineering drawings, specifications, tolerances, and inspection
• requirements.
• Knowledge of statistical quality techniques, including sampling plans, process capability
• (Cp/Cpk/Pp/Ppk), and data analysis.
• Experience with risk management tools such as FMEA preferred.
• Experience with process validation and IQ/OQ/PQ preferred.
• ASQ certification such as CQE, CQA, or CSQP is a plus.
• Proficient with Microsoft Office and Google Workspace; experience with ERP and
• electronic QMS systems preferred.
• Strong analytical and problem-solving skills.
• Strong written and verbal communication skills with the ability to communicate
• effectively with suppliers, internal teams, and management.
• Ability to manage multiple priorities and work independently in a fast-paced
• environment.
• Detail-oriented with strong organizational and time-management skills.
• Willingness to travel domestically and internationally as needed.

Benefits:

• Paid parental leave
• Scholarship reimbursement
• 401k match
• Benefits effective day one of employment
• Paid short term disability leave
• Generous PTO policy that starts on day one
• Paid holidays
• Health and wellness program
• Employee discount program within our family of companies