Quality Engineer role at Miller Technical Services (MTS)

SEMCA MICHIGAN WORKS • Livonia, MI • 4h ago

Job Title: Quality Engineer (Entry Level to Mid-Senior Level) Location: Plymouth Township, MI Reporting To: Quality Manager or Director of Quality

Company Overview: MTS is a U.S. FDA-registered, ISO 13485-certified contract manufacturer specializing in highly complex medical device manufacturing --- from electro-mechanical systems to Class I/II/III products. (mtsmedicalmfg.com) We're committed to being a true "vested partner" with our medical device clients, offering full lifecycle support including engineering, manufacturing, testing, assembly, and aftermarket service. (mtsmedicalmfg.com)

Position Summary: As a Quality Engineer at MTS, you will manage quality responsibilities across multiple product lines in a regulated medical device environment. You will investigate and resolve product/component non-conformances, establish and maintain inspection criteria, and drive continuous improvement activities including validation, audits, training, CAPA (Corrective and Preventive Actions), and data trending. This role is critical to ensuring our manufacturing operations meet regulatory (FDA) and standard (ISO 13485) requirements, while driving product quality and process robustness.

Key Responsibilities:

Investigate product or component non-conformances, root-cause analysis and corrective action implementation.

Establish, maintain and improve inspection criteria, test methods, sampling plans and acceptance criteria for components, sub-assemblies and finished devices.

Lead or support internal and external audits (supplier audits, internal quality audits, client audits) and ensure compliance to ISO 13485 and FDA QSR standards.

Perform process and product validations (IQ/OQ/PQ), design validation support, and ensure documentation is compliant.

Analyze quality data: non-conformance trends, SPC, CAPA effectiveness, supplier quality performance, and drive improvements.

Develop and deliver quality training for manufacturing, inspection and supplier personnel.

Support supplier quality activities: supplier qualification, supplier corrective actions, source inspections or supplier auditing.

Participate in change control, document and record management, and product release decisions as needed.

Collaborate cross-functionally (engineering, production, supply chain, R&D, regulatory) to ensure quality is built into the process.

Contribute to continuous improvement initiatives (lean, six sigma, poka-yoke, error-proofing) to reduce defects, scrap and increase yield.

Required Qualifications:

Bachelor's degree in Biomedical, Mechanical, Electrical Engineering or a related technical discipline.

Previous experience in the medical device industry (manufacturing, quality engineering, regulatory) preferred.

Strong understanding of FDA regulations (21 CFR 820 QSR) and ISO 13485 quality system requirements.

Proficiency in Microsoft Office suite -- especially Word, Excel (data analysis, pivot tables, graphs) and familiarity with quality systems software.

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