Quality Engineer II Job
Additional Locations:
(n/a)
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.
Design Assurance Engineer II, CMB
About the role:
In this critical role at the Cambridge site, you will benefit from personal and professional growth in Design Quality Assurance, Quality Systems, and Medical Device resulting from collaboration with site, divisional and corporate partners. Supports quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provides focused quality engineering support within new product development to ensure the delivery of the highest quality product to the customer.
Primary focus will be to support sustaining design assurance activities for complex electrophysiology systems. Potential to support new product SUD development, capital equipment and/or medical device software development.
Your responsibilities include:
- Generation and/or review of Quality deliverables including Risk Management, Product Specification, Design V&V, Test Methods, Process Validation, Labeling.
- Participate in Product Development, Design Review, and Design Control Activities and have direct input in design verification activities and planning.
- Working closely with cross-functional teams in a fast-paced environment to review and provide feedback on project decisions and deliverables
- Investigating and resolving complaint trend and design issues
- Conducting Root Cause Analysis of product non-conformances escalated from Complaint Investigation team.
- Participating in the implementation of design improvements, product cost improvements, and CAPAs designed to meet or exceed internal and external requirements.
- Acting as an effective team member in supporting quality disciplines, decisions, and practices.
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
What we re looking for in you:
- BS in Engineering or related discipline
- 3 years plus of Medical Device experience
- Ability to work in a fast paced, dynamic environment
- Team player
- High energy problem solver capable of driving items to closure
- Excellent communication skills
Preferred
Qualifications:
- Familiarity with BSC Quality System
- Knowledge of Design Control and Risk Management
Requisition ID:
481013
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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