Develop and maintain quality systems and methodologies, support manufacturing activities, analyze quality issues, and ensure compliance with regulations.
Key Responsibilities:
- Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements
- Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives
- Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis
- Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)
- Review and develop validation and test protocols; execute qualification and validation activities with proper documentation
- Participate in new product introductions, technology transfers, and evaluation of new equipment and processes
- Ensure compliance with Quality Management Systems (QMS) and applicable regulations (e.g., ISO13485, QSR)
- Collaborate cross-functionally with engineering, operations, suppliers, and customers to resolve quality-related issues
- Analyze operational and validation data to support decision-making and continuous improvement initiatives
- Provide technical guidance or mentorship to junior engineers, technicians, or inspectors where applicable
- Support internal and external audits and maintain effective quality system documentation
Requirements:
- Bachelor’s Degree in Science or Engineering
- 3 to 8 years of experience in manufacturing and operations quality
- Experience in the medical device industry is preferred
- Experience in people management is an advantage
Required Skills:
- Strong problem-solving skills with experience in root cause analysis and quality tools
- Good understanding of Quality Management Systems and regulatory standards (e.g., ISO13485, QSR)
- Experience handling nonconformance investigations and product risk assessments
- Ability to analyze data and make sound quality decisions
- Strong communication skills with ability to clearly present findings
- Ability to work effectively in a cross-functional manufacturing environment
About Us
As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
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