Quality Engineer II - Medical Devices, Regulatory & Process

Olympus America, Inc.; Brooklyn Park (MN); On-site; USD 79,000 - 107,000; Full time

Benefits offered by this job

Competitive salaries

Annual bonus

401(k) with company match

Wellbeing programs

Paid vacation & holidays

Parental leave

Job summary

Olympus America, Inc. is seeking a Quality Engineer to provide essential Quality Engineering support ensuring compliance with the Quality System and regulatory requirements across product development, manufacturing, and servicing.

The role involves leading process improvements, applying statistical methods, and training site personnel on Quality System and regulatory standards. On-site role in Minnesota with competitive compensation and benefits.

Qualifications

• Requires a Bachelor’s degree in a science/engineering discipline.
• Equivalent industry experience acceptable as substitute.
• Minimum 3 years related experience, preferably in medical device quality/engineering.
• Strong statistical and analytical skills.
• Familiarity with FDA QSR, ISO 13485, and related regulatory standards.

Responsibilities

• Provide quality engineering support to ensure compliance with Quality System requirements.
• Represent Quality Engineering in new product development, transfers, procurement, manufacturing, and servicing.
• Lead or participate in development and changes of processes/procedures.
• Apply statistical methods to evaluate processes and changes.
• Support validation/verification strategies for products and processes.
• Drive quality improvements and CAPA activities.

Skills

Statistics

Communication

Problem solving

IT literacy

Education

B.S. in science/engineering

Equivalent industry experience

Tools

Process Mapping

Histograms

FMEA

Risk Assessment

Cause & Effect Diagrams

PDCA

Pareto Analysis

Metrology & Calibration

Job description

Olympus America, Inc. is seeking a Quality Engineer to provide essential Quality Engineering support ensuring compliance with the Quality System and regulatory requirements across product development, manufacturing, and servicing.

The role involves leading process improvements, applying statistical methods, and training site personnel on Quality System and regulatory standards. On-site role in Minnesota with competitive compensation and benefits.