Supplier Quality Engineer II

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 this role:
The Supplier Quality Engineer will play a key part in the Integration team for Access Solutions. Review the supply base, identify potential issues and work to resolve current quality system or supplier gaps. Develop quality strategies and provide input and influence to maintain compliance and integrate acquired entities and products into Boston Scientific Quality System as needed. Drive continuous improvement to the acquisition process. 
 
Your responsibilities will include:

• Supports integration activities of new sites, focusing on onboarding of new suppliers as a lead auditor in the quality management assessment, setting up incoming inspection documentation, and hybridizing procedures and knowledge sharing documents. 
• Works cross-functionally in identifying and resolving technical issues. Maintains and enhances cross-functional team relationships within the divisions, plants, distribution centers, across the entire BSC network.      
• Monitors, evaluates, and provides summary reports on project progress and results.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Champions 100% compliance to company policies and SOP’s. 
• Assists in generating materials specifications and working with the supplier engineering function in qualifying material per BSC Quality Management System requirements.
• Provides guidance regarding quality integration strategies and approaches to new acquisitions relating to product distribution and quality systems (i.e., CAPA, Post Market, distribution controls)

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.

Minimum qualifications:

• BS degree in engineering or related technical field with minimum of 3 years of relevant experience.
• Experience in process validation, design controls, risk management, and CAPA.
• Domestic and international travel up to 20%. 

Preferred qualifications:

• Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
• Ability to work independently; organized and self-driven.
• Strong 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).
• Experience with quality systems and processes, and project management. 
• Experience with medical device suppliers
• Experience as lead auditor of quality systems (ISO13485 or similar)
• ASQ certification (CQE, CBA, SSGB, SSBB)
   

Requisition ID: 559959

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 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.

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.