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Senior Quality Engineer
Location:
Brooklyn Park, MN
Description:
Working Location: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 sub:assemblies to ensure compliance with company policies and procedures and medical device regulations. The Product Quality Engineer will partner with Operations, R and D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations. id560__section_lib: Job Duties: Drive the design and execution of Production Release Process project for components and 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, and 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 ones 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 Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSRs, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors.: 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.: 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 A
Posted:
May 10 on Tip Top Job
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More About this Listing: Senior Quality Engineer
Senior Quality Engineer is a Quality Assurance Quality Engineer Job located in Brooklyn Park MN. Find other listings like Senior Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.
Senior Quality Engineer is a Quality Assurance Quality Engineer Job located in Brooklyn Park MN. Find other listings like Senior Quality Engineer by searching Oodle for Quality Assurance Quality Engineer Jobs.