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 This Role:
Develops, establishes and maintains quality trending methodologies, systems, and practices which meet BSC and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support, operational, or system/services support. Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist.
Your Responsibilities Will Include:
- Provides leadership role on championing departmental or cross-functional initiatives.
- Coordinate and maintain Quality System data to assist senior leaders in making critical assessment of the health of the quality system by executing the required elements: including data collection, data base population, conducting analysis, generating reports, creating presentations, participating in core team meetings, and documentation through meeting minutes or released quality documents.
- Provides project direction, coaching, and mentoring for analysts and divisional trending teams.
- Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
What We’re Looking For In You:
- Bachelor’s Degree in the Engineering or Science field, plus 6-9 years of related experience or an equivalent combination of education and work experience.
- Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485.
- Strong analytical skills and working knowledge of Trackwise and/or SAS applications
- Strong communication skills and comfortable speaking and presenting to leadership
- Knowledge of additional external regulations, including 21 CFR Part 4, 21 CFR Part 11, ISO 14971, Medical Device Directive 93/42/EEC , Therapeutic Goods (Medical Devices) Regulations, MHLW Ministerial Ordinance No. 169, SOR/98-282, and RESOLUTION RDC Nº 16
- Experience with Post Market systems / processes
- Experience with CAPA, Management Review / Controls, and External Audits
- Flexible and positive attitude
- Project management
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.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 459476