Senior Quality Assurance Specialist
1 day ago
Olympus Corporation of the Americas is a leading medical technology company dedicated to improving lives through innovative solutions. Our Medical business uses cutting-edge capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver high-quality diagnostic, therapeutic, and minimally invasive procedures.
SalaryThe anticipated base pay range for this full-time position is $95,665.00 - $129,148.00 per year, plus potential for annual bonus (subject to plan eligibility and other requirements).
Job DescriptionWe are seeking an experienced Product Quality Engineer to join our team in Westborough, Massachusetts. The successful candidate will be responsible for designing, developing, and managing projects for legacy products, ensuring compliance with company policies and medical device regulations.
This role involves working closely with internal/external manufacturers, operations, R&D, supply chain, and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.
The ideal candidate will have a strong background in quality engineering, experience working in an FDA-regulated environment, and excellent technical problem-solving skills using Six Sigma tools.
Required Skills and Qualifications- 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, EUMDR, and Human Factors.
Olympus offers a comprehensive benefits package, including:
- 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 virtual live and on-demand wellness classes.
- Work-life balance supportive culture with hybrid and remote roles.
- 12 Paid Holidays.
- Education 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 (limited locations).
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