Senior Quality Engineer - 18 Month Defined Term
Boston Scientific
Summary
This role is for a Senior Quality Engineer supporting Boston Scientific's Valencia Technologies acquisition. In this role, you will serve as a key Quality representative with responsibility spanning Manufacturing Quality and Quality Systems. You will provide quality leadership and support for production operations while driving compliance across the site's Quality Management System. You will ensure alignment with internal procedures, regulatory requirements and industry standards while supporting product quality, issue resolution, process effectiveness and audit readiness.
Job description
Your responsibilities will include:
- Serve as the Quality representative and subject matter expert, providing guidance, training and support to ensure the consistent application of quality and regulatory requirements.
- Collaborate cross-functionally with Operations, Manufacturing, Supply Chain, Regulatory Affairs, Research and Development (R&D), and other key stakeholders to resolve quality issues.
- Interpret technical drawings, procedures and specifications to ensure compliance with applicable requirements.
- Lead or support quality investigations, including manufacturing defects, failure analyses, corrective and preventive actions, and the disposition of nonconforming product.
- Review and approve validation, operational and test data to ensure compliance with product, process and quality system requirements.
- Support internal and external audits, ensuring compliance with regulatory and quality system requirements.
Required qualifications:
- Bachelor's degree in science, engineering or a related technical discipline.
- Minimum of 5 years' experience in the medical device or pharmaceutical industry.
- Strong understanding of regulatory and quality system requirements, including ISO 13485 and the Quality Management System Regulation (QMSR).
- Proven ability to resolve complex issues using structured problem-solving methodologies, supported by strong knowledge of quality operations, product risk assessment and data analysis.
- Experience leading nonconforming event risk assessments and quality investigations.
Preferred qualifications:
- Audit experience.
- Excellent verbal and written communication skills.
- Ability to collaborate and communicate effectively across all levels of the organization.
- Demonstrated ability to work independently and effectively in a team environment.
- Continuous improvement mindset with a passion for quality.
Requirements
- Bachelor's degree in science, engineering or a related technical discipline.
- Minimum of 5 years' experience in the medical device or pharmaceutical industry.
- Strong understanding of regulatory and quality system requirements, including ISO 13485 and the Quality Management System Regulation (QMSR).
- Proven ability to resolve complex issues using structured problem-solving methodologies, supported by strong knowledge of quality operations, product risk assessment and data analysis.
- Experience leading nonconforming event risk assessments and quality investigations.
- Audit experience.
- Excellent verbal and written communication skills.
- Ability to collaborate and communicate effectively across all levels of the organization.
- Demonstrated ability to work independently and effectively in a team environment.
- Continuous improvement mindset with a passion for quality.
Benefits
- Health Insurance
- Annual Bonus
- Long-term Incentives
Company overview
Boston Scientific Corporation is a global leader in the development, manufacturing, and marketing of minimally invasive medical devices used in interventional medical specialties. Founded in 1979 and headquartered in Marlborough, Massachusetts, the company focuses on transforming patient lives through innovative medical solutions across a wide range of therapeutic areas including cardiology, endoscopy, urology, pulmonology, and neuromodulation. With approximately 53,000 employees worldwide and operations in 40 countries, Boston Scientific serves over 44 million patients annually. The company invests heavily in research and development, allocating $1.6 billion to R&D in 2024, and maintains a strong commitment to quality, patient safety, and meaningful innovation. Boston Scientific's product portfolio includes advanced technologies such as cardiac rhythm management devices, coronary stents, ablation systems, endoscopy equipment, and neuromodulation therapies, all designed to improve patient outcomes and quality of life through less invasive treatment options.