Supplier Quality Engineer

Crecera Brands•Caledonia, MI

16d

About The Position

The Supplier Quality Engineer (SQE) ensures that suppliers consistently meet Marketlab’s quality, regulatory, technical, and performance requirements. The role is 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. Responsibilities span supplier qualification and monitoring, supplier audits, incoming quality controls, nonconforming material investigations, supplier corrective actions, product specifications, risk management, and continuous improvement. The role also provides Quality Engineering support for new and existing products to help ensure supplier-manufactured products meet defined specifications and applicable Quality Management System requirements. It reports to the Quality and Regulatory Manager. The position includes coordination with Asia-based suppliers and travel to supplier locations for audits, investigations, process reviews, qualifications, and improvement activities. It supports compliance with ISO 13485, ISO 9001, FDA Quality Management System requirements, and other applicable regulations.

Requirements

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 is preferred.
Experience working directly with Asia-based suppliers is required, including supplier qualification, quality issue resolution, corrective actions, and ongoing supplier performance management.
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.
Proficiency with Microsoft Office and Google Workspace.
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.
Ability to manage supplier quality activities across time zones, language differences, and cultural and business practices.

Nice To Haves

Experience conducting supplier audits and working with manufacturing partners in China and other Asian countries.
Experience working with and providing direction to international or remotely based employees or quality personnel.
Experience working in a regulated manufacturing environment; medical device experience is highly desirable.
Experience with risk management tools such as FMEA.
Experience with process validation and IQ/OQ/PQ.
ASQ certification such as CQE, CQA, or CSQP.
Experience with ERP and electronic QMS systems.

Responsibilities

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, assess potential systemic impacts across products, lots, and product families, and 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 and support compliance with applicable standards, regulations, and 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.