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Principal Quality Systems Engineer - Cardiac Rhythm Management & Diagnostics (CRMDx)

Boston Scientific · Arden Hills, MN

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Level
Senior
Team
Quality
Travel
10%
Degree
Required
Experience asked
8+ years
Industry
Medical devices
Posted
9 days ago

The role in 30 seconds

A senior quality role at Boston Scientific (medical devices) in Arden Hills, MN.

They ask for
8+ years · degree required
Tools it names
ISO 13485, FDA / GMP
Day to day
about 10% travel · relocation help

Read from the posting. The full description is below.

It asks for 8+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Promotion path mentionedRelocation help

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

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  1. 1

    Pick 2–3 people on the Quality team at Boston Scientific

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  2. 2

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  3. 3

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    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • The posting says about 10% travel. Between which sites?
    • How did you land the job? What stood out in your interviews?
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  5. 5

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About the role

About the role

This Principal Quality Systems Engineer serves as a Design Control representative leading awareness, visibility, and communication of quality initiatives in support of global and CRM quality goals. This role is responsible for compliance of the CRM Design Control to BSC Global Quality System and applicable regulatory

requirements

and standards.

Required Qualifications

  • ✓Bachelor’s degree in science, Engineering, Health, or related fields
  • ✓Minimum of 8 years of work experience in the medical device or other regulated industry
  • ✓Solid computer skills required including Excel, Word, and PowerPoint
  • ✓Strong communication skills (verbal and written)

Preferred Qualifications

  • ✓Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485:2016
  • ✓Project management experience
  • ✓Experience within BSC quality systems
  • ✓Experience with Design Control process
  • ✓Experience working with cross functions teams such as Regulatory, Research and Development, Clinical, and Quality
  • ✓Strong presentation skills
  • ✓Travel is very limited, maybe up to 10%

Minimum Salary: $ 102100

Maximum Salary: $ 194000

For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

Please be advised that certain US based positions, including without limitation field sales and se

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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.

Work Mode

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation Assistance

Relocation assistance is not available for this position.

Visa Sponsorship

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

Your

will include

  • •Deliver and manage completion of CRM divisional deliverables, including updates to procedures, Work Instructions, and knowledge sharing documents
  • •Active membership of Global Procedural and Design Control Community of Practice
  • •Drive and provide guidance to team members regarding quality strategies driven by BSC Global Quality System
  • •Provide project direction, coaching, and mentoring for engineering and technical team personnel
  • •Work cross-functionally in identifying and resolving procedural issues
  • •Drive continuous improvement initiatives to enhance CRM Design Control Process and its efficiency while maintaining or improving product quality
  • •Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • •Advise management on potential improvements or enhancements to quality systems and processes in the company.
  • •Promote a culture of quality and compliance within the organization through regular communication and training.
  • •Provide essential support during internal and external audits by presenting Design Control storyboard in front room and addressing questions related to CRM DC process. Provide back room support by supplying necessary documentation and leading DC backroom stream.
  • •Establish or maintain CRM design control procedures, templates, and tools

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