Senior Quality Engineer, Product

Workplace Flexibility:
Hybrid

The Product Quality Engineer is responsible for the design, development and management of projects for legacy products. The Product Quality Engineer provides organizational support with a focus on Design Quality activities. Works with internal/external manufacturers providing finished products, services, components, and subassemblies to ensure compliance with company policies and procedures and medical device regulations. The Product Quality Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.

• Drive the design & execution of Production Release Process project for components & finished devices.
• Lead and implement complex projects including quality improvement initiatives.
• Sets direction for cross‑functional teams and drives towards compliant and efficient solutions to complex problems.
• Provide leadership in understanding of the quality regulations to other disciplines.
• Support Process/Design Validation Verification activities and approach including software validation.
• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting.
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in‑house / external manufacturing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Required:

• Bachelor's Degree in Engineering required.
• Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
• Strong working knowledge of technical problem solving via Six Sigma type tools to analyse, drive root cause, and solve problems.
• Proven track record in Sustaining Engineering, support of commercialised products and Post Market Surveillance.
• Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors.
• Strong written and oral communication skills.
• Ability to thrive in a fast‑paced, dynamic and deadline‑driven environment.
• Well organized, flexible self‑starter, team motivated and excellent at prioritising and multi‑tasking.
• Skilled in presentation development and public speaking.
• Up to 10% domestic travel.

• Competitive salaries, annual bonus and 401(k) with company match.
• 24/7 Employee Assistance Program.
• Free live and on‑demand Wellbeing Programs.
• Generous Paid Vacation and Sick Time.
• Paid Parental Leave and Adoption Assistance.
• 12 Paid Holidays.
• On‑Site Child Daycare, Café, Fitness Center.

Applicants requesting accommodations:
Olympus is committed to the full inclusion of all qualified individuals. If reasonable accommodation is needed, please contact  or call

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 status, religious creed, age, sex, gender, sexual orientation, marital status, disability, genetic information, ancestry, veteran status or any other characteristic protected by applicable federal, state or local law.

Posting Notes:
United States (US)
• Minnesota (US‑MN)
• Brooklyn Park
• Quality & Regulatory Affairs (QA/RA)