Senior Quality Assurance Engineer
1 week ago
Job Summary:
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Boston Scientific Gruppe. As a key member of our quality team, you will be responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet regulatory requirements.
Key Responsibilities:
- Quality Engineering: Develop and implement quality engineering methodologies, systems, and practices that meet regulatory requirements.
- Regulatory Compliance: Ensure compliance with all relevant regulations, including FDA, ISO, cGMP, and MDR.
- Auditing: Plan, coordinate, and conduct scheduled audits to assess compliance with regulatory requirements.
- CAPA System: Lead the implementation of CAPA systems designed to meet or exceed internal and external requirements.
- Process Improvement: Identify areas of potential noncompliance or improvements and implement process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance, and standards.
- Training and Development: Educate functional areas on quality system requirements and provide training and development opportunities to ensure a culture of quality.
- Collaboration: Collaborate with cross-functional teams to standardize Boston Scientific Gruppe quality system policies and procedures.
Requirements:
- Education: Bachelor's degree in Science or Engineering.
- Experience: At least 8-10 years of working experience in a related field, with experience in medical devices manufacturing industry being an added advantage.
- Skills: Knowledge in ISO13485, EU MDR, FDA Regulations, cGMP, and Combination Device Regulations.
About Us:
Boston Scientific Gruppe is a global medical technology leader dedicated to transforming lives through innovative medical solutions that improve patient health. We are committed to making a positive impact on the lives of our patients, customers, and employees.
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