Senior Product Quality Engineer
Olympus Corporation of the Americas
Summary
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 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 description
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/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.
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 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.
Requirements
- 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
Benefits
- Competitive salaries
- Annual bonus
- 401(k) with company match
- Medical, Dental & Vision
- Employee Assistance Program
- Wellbeing Programs
- Paid Vacation
- Sick Time
- Paid Parental Leave
- Adoption Assistance
- Paid Holidays
- On-Site Child Daycare
- Café
- Fitness Center
- Paid volunteering
- Charitable donation match
- Employee Resource Groups
- Training Resources
- Learning & Development
- Paid Educational Assistance
Company overview
Olympus Corporation of the Americas is a leading global medical technology company and a wholly owned subsidiary of Olympus Corporation, headquartered in Center Valley, Pennsylvania. As a pioneer in the medical device industry, Olympus specializes in developing and manufacturing advanced endoscopic solutions, minimally invasive surgical equipment, and diagnostic imaging systems. The company holds approximately 70% of the global endoscope market, with a comprehensive portfolio that includes gastrointestinal endoscopes, laparoscopes, bronchoscopes, urological devices, and video imaging platforms. With over 5,200 employees across North and South America, Olympus focuses on creating innovative medical technologies that enable early detection, diagnosis, and minimally invasive treatment of diseases. The company's products are used across multiple medical specialties including gastroenterology, pulmonology, urology, and general surgery, helping healthcare professionals improve clinical outcomes while reducing procedural costs. Olympus continues to invest heavily in research and development, digital healthcare solutions, and AI-powered diagnostic tools to maintain its leadership position in the medical technology sector.