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Senior Supplier Quality Engineer, Software
Location:
Westborough, MA
Description:
Working Location:MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY 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 Senior Supplier Quality Engineer, Software is responsible for the product:related supplier quality within the supplier:provided software category. The Sr. SQE will be involved in New Product development, ensuring the suppliers meet Olympus requirements and industry standards. This role will be an integral part of the initial and ongoing auditing of suppliers for software controls. id510__section_lib: Job Duties id512__section_lib:: Acts as supplier quality engineering representative in new product development projects: Performs Advanced Product Quality Planning (APQP) by applying the appropriate methods including early supplier involvement into development projects and assures that required process validations are sufficiently implemented: Coordinates and ensures the external software qualification/validation process is effective: Identifies gaps in suppliers capabilities / technical project risks: Makes decisions on acceptance or rejection of software product: Develops validation process for software in collaboration with suppliers: Responsible for SCAR process as part of the NC process: Leads improvement projects at the supplier: Acts as primary interface to supplier regarding software product related quality matters: Analyzes product related supplier quality issues: Supports facility audits by outside agencies (i.e., FDA, ISO/ MDSAP): Supports Supplier audits for new suppliers and ongoing surveillance audits for existing suppliers.: Performs local supplier management such as supplier approval, Quality Agreement negotiation and supplier evaluation. Job Qualifications Required: : Minimum requirements are a BA/BS degree or equivalent in a Computer Science, Life Science, Engineering, or Physical Science with an advanced technical degree.: Minimum of5:10 years in a related field: Knowledge of industry software development standards such as IEC 62304 and/or IEC 82304: Familiarity with cyber security standard ISO/IEC 81001:5:1: Experience with supplier audits for software controls: Understanding of software validation processes: Knowledge of embedded software in medical devices and purchased software as a product: Very good knowledge of Quality tools and methods: ISO 9001 I FDA I Medical technology background: Basic project management skills: Advanced English: 20 travel should be expected.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 and 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, confid
Posted:
May 1 on Tip Top Job
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More About this Listing: Senior Supplier Quality Engineer, Software
Senior Supplier Quality Engineer, Software is a Quality Assurance Quality Engineer Job located in Westborough MA. Find other listings like Senior Supplier Quality Engineer, Software by searching Oodle for Quality Assurance Quality Engineer Jobs.
Senior Supplier Quality Engineer, Software is a Quality Assurance Quality Engineer Job located in Westborough MA. Find other listings like Senior Supplier Quality Engineer, Software by searching Oodle for Quality Assurance Quality Engineer Jobs.