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Quality Systems Engineer II

3 months ago


Arden Hills, Minnesota, United States Boston Scientific Full time

Additional Location(s): N/A

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:

We are looking for a detail-oriented individual to join the CAPA team in the Arden Hills Quality Systems department. In this role, your primary focus will be CAPA activities, including CAPA mentoring and training.

Your responsibilities will include:

Support site CAPA and NCEP activities as a SME, mentor and/or trainer

Champion quality and compliance to quality requirements throughout the NCEP and CAPA process

Support timely implementation of projects within the Arden Hills Quality Operations organization, including continuous improvement projects

Work with team members to identify areas within NCEP/CAPA in need of improvement and support such improvements

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities

What we're looking for in you:

Required qualifications:

  • Bachelor's degree
  • Minimum of 2 years of related work experience, preferably in the medical device industry, or an equivalent combination of education and work experience
  • Demonstrated problem solving skills, preferably in the CAPA process

Preferred qualifications:

  • Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
  • Strong verbal and written communication, project management, and organizational skills
  • Ability to influence and indirectly lead including in challenging situations
  • Ability to communicate effectively with different levels of the organization
  • Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential

Requisition ID: 588773

Among other requirements, Boston Scientific maintains specific prohibited substance testing 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 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 prohibited substance free workplace. Pursuant to Va. Code § , 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.