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Quality Engineer II
3 months ago
About the role
At Boston Scientific, we improve the quality of our products and processes to drive improvement in patient outcomes. We are looking for a Quality Engineer* II (QE II) to drive the build out our local management systems to support compliance and product quality. This role brings together a blend of operational/supplier quality with quality systems design and is listed as 1-year contract, with the possibility of extension.
Your responsibilities will include:
- Track/trend service provider performance to establish thresholds for action.
- Dispositioning raw materials.
- Work with internal stakeholders to obtain relevant information required to investigate quality events.
- Liaise effectively between external service providers to drive quality events to resolution.
- Aid in development of quality documentation, including manuals, policies, procedures, work instructions, and forms.
- Writing of quality documentation, including manuals, policies, procedures, work instructions, and forms.
- Support in internal and external regulatory audits.
- Other duties as assigned.
Required qualifications:
- Bachelor's Degree in Science or Engineering or relevant and progressive work experience in lieu of degree (Minimum of 8 years’ experience in GMP environment)
- 1-3 years of relevant work experience in the medical device industry, directly supporting Quality Management Systems and documentation
- Knowledge of ISO 13485, MDSAP, ISO 9001, ISO 11607, and/or AIMDD/EU MDR
- Ability to travel domestically and/or internationally up to 10%.
Preferred qualifications:
- Works well with diverse personalities.
- Highly organized
- Critical thinking