Job Description

Additional Locations: US-IL-Chicago; US-IN-Indianapolis; US-MA-Boston; US-MI-Detroit; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Northern/Duluth; US-MN-Plymouth; US-PA-Philadelphia; US-TX-Houston; US-WA-Bellevue/Redmond; US-WA-Seattle

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, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.

Supplier Quality Engineer II

Location: This position can be located in any US Boston Scientific site or be remote.

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 Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our suppliers 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:

* Supports the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
* Generates and reviews 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 SOPs.

What were looking for in you:

Minimal Qualifications:

* BS degree in engineering or related technical field with minimum of 2-4 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 25%. 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:

* Medical device engineering experience preferred.
* 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 youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.

Requisition ID: 470507