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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 purposeimproving lives through your life's work.
Senior Quality Engineer
About the role:
The Senior Quality Engineer provides focused quality engineering support in a lead role for site, divisional, or global projects. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to support departmental, functional, site, divisional and global quality goals and priorities within a collaborative team environment.
Your responsibilities will include:
Provides leadership role in championing departmental or cross-functional engineering initiatives.
Provides project direction, coaching, and mentoring for engineering and technical team personnel.
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
Establish effective corrective action plans. Lead in implementation of quality assurance plans, 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, including FMEA.
Review and approve product, process, software qualification and validation and other change control related documentation.
Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure BSC regulatory, FDA and ISO compliance in all areas of responsibilities.
Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
What we're looking for in you:
5+ years' relevant experience and bachelor's degree in Quality Engineering or related discipline.
3 - 5 years' medical device experience.
Demonstrated used of Quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, , process validation (IQ, OQ, PQ) and FDA, ISO/MDD standards.
Experience leading projects, coaching, and mentoring for engineering and technical team personnel.
Demonstrated interpersonal skills with ability to work within a team environment.
Strong written/verbal 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.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 453202