Senior Quality Engineer (Remote) Job
Additional Locations: US-MN-Maple Grove; Costa Rica-Coyol; Costa Rica-Heredia; US-CA-Valencia; US-IN-Spencer; US-MA-Cambridge; US-MA-Quincy; US-MN-Arden Hills; US-MN-Minnetonka
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance
At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing whatever your ambitions.
Senior Quality Engineer
About the role:
The Senior 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. Specifically, this role will lead or support Quality initiatives, ensuring compliance to Medical Device regulations and BSC Quality System requirements with a continuous improvement mindset.
Please note that this role can be located at any BSC site or location
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.
- 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.
- Participates on CAPA and Lean Business project teams as appropriate.
- Other duties as necessary or required by the department or organization.
What we re looking for in you:
Minimum Qualifications
- Bachelor's degree and 5
years or Masters degree and 3
years of experience in a medical device manufacturing, quality or regulatory/compliance environment - Previous experience in Quality Systems or Country/Distribution QA or having experience in working in the Commercial/Supply Chain organization.
- Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Technical writing and documentation skills
- Fluent in English language
- Project management skills
- Willingness to travel internationally
Preferred Qualifications
- Degree(s) in Science or Engineering
- 5
years of experience in Quality Systems - Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
- Good working knowledge of SAP would be beneficial
- Advanced level of Microsoft Excel (including macros) and databases development
- Software validation experience
Requisition ID: 476526
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Estimated Salary: $20 to $28 per hour based on qualifications.
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