Quality Assurance Specialist
3 weeks ago
About the Role
Boston Scientific is seeking a Quality Engineer II to drive the build out of 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 a 1-year contract, with the possibility of extension.
Your Responsibilities Will Include:
- Tracking and trending service provider performance to establish thresholds for action.
- Dispositioning raw materials.
- Working with internal stakeholders to obtain relevant information required to investigate quality events.
- Liaising effectively between external service providers to drive quality events to resolution.
- Aiding in the development of quality documentation, including manuals, policies, procedures, work instructions, and forms.
- Writing quality documentation, including manuals, policies, procedures, work instructions, and forms.
- Supporting 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.
- Effective time-management skills.
- Critical thinking.
- Resourcefulness.
About Boston Scientific
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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