Senior Quality Engineer - Product
Olympus Medical Systems
Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
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.
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 Validation Nerification 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 Qualifications
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 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, EUMDR and Human Factors.
- Up to 10% domestic travel
Preferred:
- 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.
Why join Olympus?
Here, people matter—our health, our happiness, and our lives.
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive Medical, Dental, Visions coverage effective on start date
- 24/7 Employee Assistance Program
- Free virtual live and on-demand wellness classes
- Work-life balance supportive culture with hybrid and remote roles
- 12 Paid Holidays
- Educational Assistance
- Parental Leave and Adoption Assistance
- Volunteering and charitable donation match programs
- Diversity & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center**
*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together.
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 (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)