Supplier Quality Manager

EPM Scientific; Chaska (MN); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

EPM Scientific in Chaska, MN is seeking a Supplier Quality Manager to strengthen its supplier quality function for medical devices. You will work with Engineering, Manufacturing and Supply Chain to ensure suppliers meet quality, regulatory and manufacturing requirements and own corrective actions and continuous improvement initiatives.

The role focuses on leading supplier quality activities, audits, CAPAs and risk assessments, using tools such as 8D, 5 Whys and FMEA to drive measurable quality

Qualifications

• Experience in supplier quality and manufacturing environments.
• Familiarity with audits, CAPA/SCAR, root-cause analysis.
• Knowledge of ISO 13485 and FDA quality systems.

Responsabilités

• Lead supplier quality activities across external manufacturers and suppliers.
• Manage CAPAs, SCARs, non-conformances and root-cause investigations.
• Support supplier audits, risk assessments and qualification activities.
• Collaborate with engineering to resolve manufacturing and component quality issues.
• Drive improvements in supplier performance, incoming quality and process capability.
• Apply 8D, 5 Whys, Fishbone, FMEA, SPC for problem solving.
• Support change control, validation, continuous improvement and regulatory compliance.
• Develop supplier quality metrics and analyze trends to drive improvement.

Connaissances

Supplier Quality

Quality Engineering

Manufacturing Quality

Formation

Bachelor's degree in Engineering or Life Sciences

Description du poste

Supplier Quality Manager - Medical Devices

Location: Chaska, MN
Permanent | Full-Time

We are partnering with a leading medical technology organisation looking to appoint a Supplier Quality Manager to strengthen its supplier quality function in Chaska, Minnesota.

This is an excellent opportunity for an experienced Supplier Quality professional who enjoys being close to the product, working directly with suppliers and having ownership over quality improvement rather than operating purely within documentation and compliance.

The Role

You will play a key role in ensuring external suppliers consistently meet the organisation's quality, regulatory and manufacturing requirements. Working closely with Engineering, Manufacturing, Supply Chain and Quality teams, you will help improve supplier performance, resolve complex quality issues and reduce risk across the supply base.

Key responsibilities will include:

• Leading supplier quality activities across external manufacturers and component suppliers, from qualification and onboarding through ongoing performance management.
• Managing supplier CAPAs, SCARs, non-conformances and root-cause investigations, ensuring robust corrective actions and preventing recurrence.
• Performing and supporting supplier audits, risk assessments and supplier qualification activities.
• Partnering with suppliers and internal Engineering teams to resolve technical manufacturing and component quality issues.
• Driving improvements in supplier performance, incoming quality, process capability and manufacturing consistency.
• Using quality tools including 8D, 5 Whys, Fishbone, FMEA, SPC and statistical analysis to identify and eliminate systemic problems.
• Supporting supplier-related change control, validation, continuous improvement and regulatory compliance activities.
• Developing supplier quality metrics and using data to identify trends, prioritise risk and drive measurable improvement.

What We're Looking For

• Strong experience within Supplier Quality, Quality Engineering or Manufacturing Quality, ideally within medical devices, diagnostics, life sciences or another highly regulated manufacturing environment.
• Experience working directly with external suppliers and contract manufacturers on audits, CAPA/SCAR, root-cause analysis and supplier development.
• Strong understanding of ISO 13485, FDA-regulated quality systems and/or comparable regulated manufacturing standards.
• Technical understanding of manufacturing processes, engineering specifications, drawings and supplier controls.
• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences or another relevant technical discipline preferred.
• Comfortable working cross-functionally with Engineering, Operations, Procurement and external supplier teams.

Desired Skills and Experience

• Supplier Quality, Quality Assurance