Quality Assurance Manager
2 weeks ago
Overview
">Olympus Corporation of the Americas, a global medical technology leader, is seeking a Senior Quality Engineer to join our team in Bartlett, Tennessee. With over 100 years of experience, we strive to deliver innovative solutions that improve patient outcomes and elevate the standard of care.
">About the Role
">This senior quality engineer position plays a critical role in ensuring compliance with regulatory requirements and company strategy. The ideal candidate will have a strong background in quality engineering, leadership skills, and experience working in the medical device industry.
">Responsibilities
">- Provide quality engineering support to ensure compliance with regulatory requirements and company strategy
- Represent quality as a team member to support new product development, procurement, manufacturing returns, and servicing of products produced
- Serve as a backup for the management representative for the location
Requirements
">- Bachelor's degree in Engineering discipline or equivalent
- Minimum of 5+ year's related experience and/or training; preferably in the medical device industry related to process/quality engineering
- Leadership experience (i.e., people and administrative skills); ability to lead and manage cross-functional teams
- Knowledge of basic mechanical testing and material properties
- Knowledge of metrology
- Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD 93/42 ISO 13485-2003 and Canadian Medical Device requirements
- Working knowledge of problem-solving skills – good statistical and analytical skills
- Working knowledge of problem-solving tools (i.e., process mapping, histograms, FMEA, risk assessment, cause & effect diagrams, PDCA Pareto analysis)
- Working knowledge of quality tools (i.e., quality planning, quality costs and assessment, basic statistics, advance statistical techniques, technical writing, metrology & calibration inspection and testing, sampling)
- Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management
- Proven project management skills
- Proficient in the use of information technology and applications
Benefits
">- Competitive salary range: $83,187 - $112,302 per year, plus potential for annual bonus
- 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**
Why Olympus?
">We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
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