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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.
Purpose: Provide expert QA support to Operations, ensuring quality, cost, and output objectives are met.
Key Responsibilities:
- Drive process improvements to ensure predictable processes across shipping and boxpack processes.
- Provide effective QA support to Operations to meet quality, cost, and output objectives.
- Ensure all process variables and interactions are adequately defined.
- Identify and address failure modes in the process.
- Drive plant-wide quality system improvements.
- Ensure regulatory compliance with cGMPs of medical device regulatory agencies.
- Provide functional expertise on quality-related issues.
- Implement statistical techniques to monitor process performance.
- Approve change requests for product, process, and quality system changes.
- Analyze customer complaints and identify trends.
- Manage Sterile Returns and IDD processes.
- Define and approve validation requirements and protocols.
- Compile regulatory documentation.
- Review MRB trends and identify corrective actions.
- Perform internal quality audits.
- Support Lean Manufacturing implementation.
- Transfer and implement product and processes.
Requirements:
- Bachelor of Science Degree in Engineering/Technology.
- 2-3 years' experience in a manufacturing environment or equivalent.
- Direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
Boston Scientific is a collaborative culture driven by a passion for innovation, solving healthcare industry challenges, and improving lives through meaningful work.
We are an Equal Opportunity Employer.