Sr Quality Systems Engineer

Boston Scientific   •  

Arden Hills, MN

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 164 days ago

This job is no longer available.

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

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 purpose—improving lives through your life’s work.

 About the role:

The primary focus of this Senior Quality Systems Engineer will be on project management as well as integration/acquisition support. This position will involve a combination of leading and/or supporting Quality System acquisition integration activities as well as leading and/or supporting a multitude of projects within the Arden Hills Quality Operations organization.

Your Responsibilities:

  • Lead and / or support Quality integration activities impacting the Arden Hills site and/or Rhythm Management division
  • Be a subject matter expert in matters relating to integration of Quality processes into the BSC Quality System with the ability to make sound decisions regarding how to best integrate processes efficiently, effectively and compliantly; May act as a Quality Systems/CAPA mentor to acquired company personnel
  • Lead and/or support implementation of projects within the Arden Hills Quality Operations organization
  • Develop projects charters, identify key stakeholders and communication plans, identify and recruit team members, identify and track project milestones, implementation plans, resources and responsibilities
  • Lead project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans
  • Resolve project roadblocks and obstacles by working with team members, project customers, escalating to management, and others as appropriate
  • Communicates project progress to key stakeholders
  • May support Global scale projects as a representative of Arden Hills or Rhythm Management division
  • Promote a work environment that supports the Quality Policy, Global BSC Quality System, Continuous Improvement and Winning Culture at Arden Hills
  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
  • Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the positionsresponsibilities

     What we are looking for

Qualifications:

  • Bachelor’s degree and 5+ years relevant experience, preferably in medical device industry
  • Hands on Project Managementexperience; Integration experience a plus
  • Comprehensive understanding of regulations and standards listed in the BSC Global Policy Quality System Management:  21 CFR Part 820, ISO 13485, AIMDD, MDD, MHLW, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC No 16 or March 28, 2013, 21 CFR Part 4, as applicable to our site
  • Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
  • Excellent verbal / written communication, interpersonal, project management, and organizational skills; must be able to multi-task, and analyze information quickly
  • Ability to communicate with all levels of the organization
  • Must be able to work independently, lead and / or participate as part of a team
  • Must be proactive, work independently, and be a contributing member of a highly visible team

 About us

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: 425369