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Senior Supplier Quality Engineer Job

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Date: Nov 21, 2020

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

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.

 

Senior Supplier Quality Engineer- Sourced Finished Medical Devices 

About the role:

The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our contract manufacturer and OEM supplier’s manufacturing processes.

 

Your responsibilities will include:

Sustaining Engineering:

  • Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
  • Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
  • Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.

 

New Product Development:

  • Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
  • Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

 

Quality System Champion:

  • Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
  • Identifies and advises management on potential improvements to quality systems and processes in the company.
  • Champions 100% compliance to company policies and SOP’s.

 

What we’re looking for in you:

Minimal Qualifications:

  • BS degree in engineering or related technical field with minimum of 2-5 years of relevant experience.
  • Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
  • Experience in process validation, design controls, risk management, and CAPA.
  • Ability to work independently; organized and self-driven.
  • Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
  • Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
  • Domestic and international travel up to 20%. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.

 

Preferred Qualifications:

  • 7+ years of medical device engineering experience preferred.
  • Leadership experience on a materials or service commodity team.
  • Lead auditor of quality systems experience (ISO 13485 or similar).
  • ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.

 

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

 

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.

Requisition ID: 470383

 


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