Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About the role
The Sr. QA Specialist will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. This role will support the Quality Master Pan (QMP) relating to the EU Medical Device regulations and specifically will focus on the Economic Operator – Importer and Distributor Obligations workstream in that program, ensuring compliance to Medical Device regulations and BSC Quality System requirements.
This role can be based in ANY Boston Scientific European hub (UK-Hemel Hempstead, France-Paris, Italy-Milan, Spain-Madrid, Germany-Ratingen, Netherlands-Kerkrade or Poland-Warsaw)
Your responsibilities include
- Responsible for the communication and documentation of internal and external compliance-related information including changes in regulations, new guidelines and guidance documents and other information from regulatory authorities.
- Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
- Documents audit non-conformances, evaluates impact, and makes recommendations for corrective actions.
- Communicates non-conformances to owners, managers, directors, and upper management.
- Keeps abreast of current worldwide regulatory requirements, including VAWD and licensure requirements.
- Supports departmental, functional, divisional, and corporate quality goals and priorities.
- Act as leader or team member in supporting quality disciplines, decisions, and practices
- Builds quality into all aspects of work by maintaining compliance to all quality requirements.
Who are we looking for
- An experienced quality professional with medical devices experience 1-5 yrs
- Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Technical writing and documentation skills is required.
- Solid understanding of (the new) EU medical device regulations
- Experience of medical device labelling requirements would be very desirable
- Must have excellent written and spoken English
- Excellent communication skills
As a global medical technology leader for more than 35 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.
Requisition ID: 461599