Senior Supplier Quality Engineer - Medical Devices (Onsite)

Grove Technical Resources, Inc.

Minneapolis (MN)

On-site

USD 110,000 - 150,000

Full time

3 days ago
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Job summary

Grove Technical Resources, Inc. in Minneapolis, MN is seeking a Senior Supplier Quality Engineer to lead supplier quality and manufacturing quality activities in the medical device space.

The role requires hands-on PPAP, APQP, PFMEA, CAPA, SCAR and supplier development experience. You will drive supplier qualification, audits, and NPI support while collaborating with Engineering, Manufacturing, Operations, and Quality to ensure compliance with regulatory requirements and to improve product

Qualifications

  • Bachelor's degree in engineering or related technical field.
  • 5+ years of relevant experience; 3+ years with an advanced degree.
  • Experience in supplier quality engineering for medical devices.
  • Hands-on PPAP and APQP experience.
  • Knowledge of PFMEA, Control Plans, FAI, supplier audits, CAPA, NCR, and SCAR.
  • Experience with root cause analysis and corrective action methodologies.
  • Strong understanding of supplier qualification, supplier development, and quality management systems.
  • Excellent communication and cross-functional collaboration skills.

Responsibilities

  • Lead supplier quality activities to ensure purchased materials, components, and processes meet specifications and quality requirements.
  • Manage supplier qualification, evaluation, approval, and ongoing performance monitoring.
  • Review APQP, PPAP, PFMEA, Control Plans, process flow diagrams, and FAI reports.
  • Investigate nonconformances and implement CAPA with cross-functional teams.
  • Lead SCARs, root cause investigations, and continuous improvement initiatives.
  • Conduct supplier audits and assessments of manufacturing capabilities and process controls.
  • Support NPI by assessing supplier readiness and quality documentation.
  • Monitor supplier performance metrics and drive quality improvements across the supply base.
  • Collaborate with Engineering, Manufacturing, Operations, and Quality to resolve supplier-related issues.
  • Ensure supplier processes and documentation comply with medical device quality standards and regulatory requirements.

Skills

Supplier Quality
APQP
PPAP
CAPA
NPI support
Root cause analysis
Process improvement
Quality systems

Education

Engineering degree

Tools

PFMEA
Control Plans
FAI
SCAR

Job description

Grove Technical Resources, Inc. in Minneapolis, MN is seeking a Senior Supplier Quality Engineer to lead supplier quality and manufacturing quality activities in the medical device space.

The role requires hands-on PPAP, APQP, PFMEA, CAPA, SCAR and supplier development experience. You will drive supplier qualification, audits, and NPI support while collaborating with Engineering, Manufacturing, Operations, and Quality to ensure compliance with regulatory requirements and to improve product

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