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Job Description
Quality Assurance Engineer sought to drive process improvements and ensure regulatory compliance in a fast-paced manufacturing environment.
At Boston Scientific, we value diversity and believe that a diverse workforce leads to innovative solutions.
We are committed to creating an inclusive workplace where varied viewpoints are welcomed and encouraged.
As a member of our Quality Team, you will provide expert QA support to Operations, ensuring operational goals and objectives are achieved.
Key Responsibilities:
- Drive and implement process improvements to ensure predictable processes across shipping and boxpack processes.
- Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost, and output.
- Ensure all process variables and their interactions are adequately defined.
- Ensure all failure modes in the process have been identified and addressed.
- Drive and implement plant-wide quality system improvements.
- Ensure Regulatory compliance in area of responsibility to c GMP's of all medical device regulatory agencies.
- Provide functional expertise to other support functions on quality-related issues.
- Identification and implementation of appropriate statistical techniques to monitor process performance.
- Approval of change requests for product, process, and quality system changes.
- Customer complaints: Analysis of returns, approval of analysis reports, and analysis of complaint trends.
- Management of Sterile Returns and IDD processes.
- Validation: Define process, product, and test method validation requirements.
- Compilation of required Regulatory documentation.
- MRB: Review of MRB trends and identification of appropriate corrective actions.
- Perform internal quality audits.
- Support the implementation of Lean Manufacturing across the site.
- Transfer and implement product and processes from development or from another manufacturing facility.
Requirements:
- Minimum of Bachelor of Science Degree in Engineering/Technology.
- 2/3 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment.
- Experience in the medical device industry is an advantage.
About Boston Scientific:
We are a collaborative company driven by a passion for innovation that keeps us connected on the most essential level.
We are committed to making a difference in people's lives around the world.
We are an Equal Opportunity Employer.