Senior Quality Engineer

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

Job Summary

The Product Quality Engineer is responsible for the design, development, and management of projects for legacy medical device products. This role focuses on Design Quality activities and collaborates with internal and external manufacturers to ensure compliance with company policies, regulations, and quality standards.

Responsibilities

• Drive the design and execution of Production Release Process projects for components and finished devices.
• Lead and implement complex projects including quality improvement initiatives.
• Set direction for cross‑functional teams and drive toward compliant and efficient solutions to complex problems.
• Lead Process and Design Risk Analysis.
• Provide leadership in understanding quality regulations to other disciplines.
• Lead multiple product Design Control activities for new product development efforts.
• Support Process, Design, Validation, and Verification activities, including software validation.
• Lead implementation of limited cost‑of‑quality concepts, including data collection and reporting.
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, bills of material, print changes, and specifications for in‑house and external manufacturing.
• Know and follow all applicable laws and policies and maintain the highest levels of professionalism, ethics, and compliance.

Qualifications

• Bachelor’s Degree in Engineering.
• Minimum of 5 years of experience in Quality Engineering within an FDA‑regulated medical device manufacturing environment.
• Strong working knowledge of problem‑solving tools such as Six Sigma, root‑cause analysis, and data‑driven problem resolution.
• Proven track record in Sustaining Engineering, support of commercialized products, and Post‑Market Surveillance.
• Strong working knowledge of statistics, sampling strategies, and design of experiments, including use of statistical software such as Minitab.
• Strong understanding of Risk Management, C&PA, and regulatory requirements such as FDA QSR, ISO 13485, ISO 14971, ISO 11135, EU MDR, and Human Factors.
• Strong written and oral communication skills.
• Ability to thrive in a fast‑paced, dynamic, deadline‑driven environment.
• Well organized, flexible self‑starter, team‑motivated, and excellent at prioritizing and multi‑tasking.
• Skilled in presentation development and public speaking.
• Up to 10 % domestic travel.

Benefits

• Competitive salary, annual bonus, and 401(k) with company match.
• Comprehensive medical, dental, vision coverage effective on start date.
• 24/7 Employee Assistance Program.
• Well‑being programs, paid vacation, sick time, parental leave, and adoption assistance.
• Paid holidays and flexible work options.
• On‑site childcare, café, and fitness center.

Location

Minnesota, Brooklyn Park (Onsite)

Applicants Requesting Accommodations

Olympus is committed to providing reasonable accommodations for the hiring process. If accommodations are needed, please contact [e-mail] or call 1‑888‑659‑6787.

Equal Employment Opportunity

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin, citizenship, religious creed, age, sex, gender identity, sexual orientation, marital status, disability, genetic information, ancestry, veteran status, or any other characteristic protected by law.