Senior Quality Engineer, Medical Devices - Onsite GR

Medtronic plc; Grand Rapids (MI); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

Health, Dental and vision insurance

401(k) plan with employer match

Paid time off

Tuition assistance

Job summary

Medtronic plc in Grand Rapids, MI is seeking a Principal Quality Engineer to oversee quality for medical devices, coordinating QA for components and finished goods. The role requires GMP/QSR/ISO13485 and MDR expertise, with quantified focus on risk assessments, PFMEA, CAPA, and V&V activities.

The candidate will lead audits, apply DMAIC and RCA methods, and utilize Minitab and Power BI for data-driven decisions, ensuring regulatory and customer requirements are met. Onsite presence is required.

Qualifications

• Master’s degree or Bachelor’s with required years of experience in quality engineering.
• Extensive knowledge of GMP, 21 CFR Part 820 QSR, ISO 13485 and MDR.
• Experience with risk assessments, PFMEA, CAPA and DMAIC.

Responsibilities

• Coordinate Quality Engineering for medical device components and finished goods.
• Ensure compliance with specifications, regulatory and customer requirements.
• Lead internal and external audits and support V&V protocols (IQ/OQ/PQ).
• Utilize Minitab and Power BI for data-driven decisions.
• Drive FTQ and process improvement using DMAIC and RCA methods.

Skills

GMP

CFR 820 QSR

ISO 13485

Risk Assessments

PFMEA

CAPA

DMAIC

RCA & 5 Whys

VSM

DOE

Minitab

Power BI

FTQ principles

V&V protocols

Education

Master’s degree in Biomedical/Mechanical/Industrial Engineering or related field

Bachelor’s degree in Biomedical/Mechanical/Industrial Engineering or related field with 7+ years of experience

Tools

Minitab

Power BI

Job description

Medtronic plc in Grand Rapids, MI is seeking a Principal Quality Engineer to oversee quality for medical devices, coordinating QA for components and finished goods. The role requires GMP/QSR/ISO13485 and MDR expertise, with quantified focus on risk assessments, PFMEA, CAPA, and V&V activities.

The candidate will lead audits, apply DMAIC and RCA methods, and utilize Minitab and Power BI for data-driven decisions, ensuring regulatory and customer requirements are met. Onsite presence is required.