Senior Supplier Quality Manager - Medical Devices

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

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