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.
Boston Scientific San Jose, California, USA Office
150 Baytech Drive, San Jose, United States, 95134
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