- Develops quality assurance strategy for sourced products including suppliers and incoming inspection in cooperation with Manufacturing Quality Assurance
- 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 component qualification/FAI process is effective
- Identifies gaps in suppliers' capabilities / technical project risks
- Accountable for incoming inspection planning
- Makes decisions on acceptance or rejection of sourced materials
- Guides inspectors regarding incoming inspections (e. g. training, standards, etc.)
- Responsible for SCAR process as part of the NC process
- Leads improvement projects at the supplier
- Acts as primary interface to supplier regarding product related quality matters
- Analyzes product related supplier quality issues
- Is part of the material review boards
- Supports facility audits by outside agencies (i.e., FDA, ISO/ MDSAP)
- Supports Supplier audits as co-auditor
- Performs local supplier management such as supplier approval, supplier auditing, QAA negotiation and supplier evaluation if delegated by SQM
- Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.
- Minimum of 5-10 years in a related field.
- 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 & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center** *US Only **Limited locations
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Senior Supplier Quality Engineer - Westborough, United States - Olympus
Description
Job Description
The Senior Supplier Quality Engineer is responsible for the product-related supplier quality within a defined material segment and / or site including part approval, SCAR handling, development project support, sustaining engineering support including non-conformance handling and incoming inspection planning.
Job Duties
Job Qualifications
Required: