Working Location: Massachusetts, Westborough Workplace Flexibility: HybridJob DescriptionThe 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 sub assemblies 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.
Job Duties- 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.
- Lead Process/Design Risk Analysis. Provide leadership in understanding of the quality regulations to other disciplines.
- Lead multiple product Design Control activities for new product development efforts. Support Process/Design ValidationNerification 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.
Job QualificationsRequired:- 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 analyze, drive root cause, and solve problems.
- 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 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, EU MDR, 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 prioritizing and multi-tasking.
- Skilled in presentation development and public speaking.
- Up to 10% domestic travel.
Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 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**
Connected Culture you can embrace:- Work-life integrated culture that supports an employee centric mindset
- Offers onsite, hybrid and field work environments
- Paid volunteering and charitable donation/match programs
- Employee Resource Groups
- Dedicated Training Resources and Learning & Development Programs
- Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position in this location is $95,904.00 - $129,470.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
