Quality Engineer II - Med Device | Onsite Career Growth

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

Benefits offered by this job

401(k) with company match

Annual bonus

Employee Assistance Program

Wellbeing programs

Paid vacation & sick time

Parental leave & adoption assistance

Paid holidays

On-site daycare

Job summary

Olympus America, Inc. is seeking a Quality Engineer to provide Quality Engineering support across product development, manufacturing transfers, procurement, and servicing.

You will ensure compliance with the Quality System and regulatory requirements, and collaborate with cross-functional teams to drive process improvements. The role requires a Bachelor's degree in science/engineering, at least 3 years in medical device quality/engineering, and strong knowledge of metrology and statistical

Qualifications

• Bachelor's degree in science/engineering required.
• Equivalent industry experience accepted.
• Minimum 3 years related experience in medical device quality/engineering.
• Knowledge of basic mechanical testing and material properties.
• Knowledge of metrology.
• Familiarity with FDA QSR and ISO 13485 and related medical device standards.

Responsibilities

• Support new product development, transfers, procurement, manufacturing, and servicing from a Quality Engineering perspective.
• Complete assigned Quality Engineering tasks to schedule.
• Promote awareness of Quality and Regulatory requirements.
• Lead or participate in development of processes and procedures.
• Apply statistical methods to evaluate processes and changes.
• Support validation and verification strategies for products and processes.

Skills

Statistical analysis

Problem solving

Written & verbal comms

Quality systems

Education

Bachelor's degree in science/engineering

Tools

Metrology

Quality engineering tools

FDA QSR / ISO 13485 knowledge

Mechanical testing basics

Job description

Olympus America, Inc. is seeking a Quality Engineer to provide Quality Engineering support across product development, manufacturing transfers, procurement, and servicing.

You will ensure compliance with the Quality System and regulatory requirements, and collaborate with cross-functional teams to drive process improvements. The role requires a Bachelor's degree in science/engineering, at least 3 years in medical device quality/engineering, and strong knowledge of metrology and statistical