Senior Quality Engineer - Medical Devices

Olympus Corporation; Minneapolis (MN); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) with company match

Comprehensive medical, dental, vision coverage

Flexible work options

On-site childcare

Job summary

Olympus Corporation seeks a Product Quality Engineer in Minnesota, Brooklyn Park, responsible for managing quality activities for legacy medical device products. The role requires strong regulatory knowledge, focusing on compliance with company policies and standards.

Ideal candidates will have a Bachelor’s Degree in Engineering and at least 5 years of experience in Quality Engineering within FDA-regulated environments. This role offers competitive salary and benefits including comprehensive medical coverage and flexible work options.

Qualifications

• Minimum of 5 years of experience in Quality Engineering within an FDA-regulated medical device manufacturing environment.
• Proven track record in Sustaining Engineering and support of commercialized products.
• Strong understanding of regulatory requirements such as FDA QSR and ISO standards.

Responsibilities

• Drive the design and execution of Production Release Process projects.
• Lead complex quality improvement projects.
• Provide leadership in understanding quality regulations.

Skills

Problem-solving tools such as Six Sigma

Risk Management

Strong written and oral communication skills

Statistical software such as Minitab

Ability to thrive in a fast-paced environment

Presentation development

Education

Bachelor’s Degree in Engineering

Job description

Olympus Corporation seeks a Product Quality Engineer in Minnesota, Brooklyn Park, responsible for managing quality activities for legacy medical device products. The role requires strong regulatory knowledge, focusing on compliance with company policies and standards.

Ideal candidates will have a Bachelor’s Degree in Engineering and at least 5 years of experience in Quality Engineering within FDA-regulated environments. This role offers competitive salary and benefits including comprehensive medical coverage and flexible work options.