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Boston Scientific Senior Quality Engineer in Arden Hills, Minnesota

Additional Location(s):US-TX-Houston Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- 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. About the role: The Sr. Quality Engineer provides critical quality engineering support to improve the products, services, and processes of the Cardiac Diagnostics division. This role is responsible for building quality into all aspects of work and leading quality initiatives centered on continuous improvement and compliance to medical device regulations as well as the BSC Quality System requirements. The individual will partner with cross-functional groups to manage document controls and NCEP/CAPA activities to ensure regulatory compliance, while fostering a culture of continuous improvement. Your responsibilities will include: Collaborating with technicians and manufacturing engineers to disposition non-conforming materials; work with suppliers and internal teams to identify the root causes of manufacturing defects and implement corrective and preventative actions to resolve quality issues Leading and participating in projects to drive continuous improvement and quality initiatives; help coordinate quality system audit related activities Communicating internal and external compliance-related information, including changes in regulations, guidelines, and other information provided by regulatory authorities Participating in validation and verification processes to support business initiatives; review and create quality documentationwithin Windchill Proactively investigate, identify, and implement best practices for quality engineering; develop and deliver related communication and training Supporting departmental, functional, divisional, and corporate quality goals and priorities Performing other duties as required Required Qualifications: Bachelor's degree withat least 5 years of experience in medical device manufacturing or similarly regulated environment Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485 Experience reviewing and writing concise technical documents Experience with document control systems (i.e. Windchill) Experience presenting on complex technical topics to internal and external stakeholders Proficient with Microsoft Office applications (Outlook, Excel, PowerPoint) Ability to travel up 5% domestically Preferred Qualifications: Working knowledge of SAP or similar inventory management systems Experience with project management Working knowledge of systematic problem-solving methodologies Detail oriented with strong organizational skills; ability to multi-task and manage competing priorities Requisition ID:584377 Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law. 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 busi ess, 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 prohibited substance 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. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

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