Principal Quality Engineer - Medical Devices, Onsite

Medtronic plc; Grand Rapids (MI); Vor Ort; USD 121.000 - 181.000; Vollzeit

Benefits dieser Stelle

Health, dental and vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

Long-term disability leave

Dependent daycare spending account

Tuition assistance/reimbursement

Simple Steps (global well-being)

Zusammenfassung

Medtronic plc in Grand Rapids, MI seeks a Principal Quality Engineer to support manufacturing and evaluate materials for compliance with product specs and regulatory requirements. Lead quality engineering for components and finished devices, ensuring GMP, QSR, ISO 13485, and MDR alignment.

The role requires risk assessments, CAPA, DMAIC, DOE, V&V (IQ/OQ/PQ), and data analytics with Minitab and Power BI. Onsite work four days a week; relocation assistance not provided.

Qualifikationen

• GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR (or its predecessor), and SOTA.
• Risk Assessments, PHA, and PFMEA.
• Non-Conformances and CAPA.
• DMAIC, RCA, 5 Whys, Fishbone, cause mapping, and VSM.
• DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV.
• Lean - Six Sigma.
• V&V protocols and IQ/OQ/PQ.
• Minitab and Power BI; product lifecycle mgmt., including quality systems and FTQ.

Aufgaben

• Coordinate Quality Engineering for medical device components and finished devices.
• Support manufacturing operations and ensure compliance with product specs and regulatory requirements.
• Lead audits and risk analyses, CAPA, and associated documentation.

Kenntnisse

GMP & QSR compliance

Risk assessment methods

CAPA & non-conformances

DMAIC & RCA

DOE & statistical methods

Lean Six Sigma

V&V protocols (IQ/OQ/PQ)

FTQ & process improvement

Ausbildung

Master's degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related engineering field

Bachelor's degree in Biomedical, Mechanical, Industrial Engineering, Engineering management or related engineering field

Tools

Minitab

Power BI

Jobbeschreibung

Medtronic plc in Grand Rapids, MI seeks a Principal Quality Engineer to support manufacturing and evaluate materials for compliance with product specs and regulatory requirements. Lead quality engineering for components and finished devices, ensuring GMP, QSR, ISO 13485, and MDR alignment.

The role requires risk assessments, CAPA, DMAIC, DOE, V&V (IQ/OQ/PQ), and data analytics with Minitab and Power BI. Onsite work four days a week; relocation assistance not provided.