Supplier Quality Engineer II - Software

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 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. As a Supplier Quality Engineer II, you play a critical role in ensuring the safety, reliability, and compliance of sourced software used as a medical device (SaMD) or in medical devices (SiMD). You collaborate with suppliers, internal teams, and regulatory bodies to maintain high-quality standards throughout the product lifecycle to consistently meet Boston Scientific’s requirements. Additionally, the Supplier Quality Engineer II will support sourcing and quality systems by participating in global communities of practice and value improvement projects. The Supplier Quality Engineering team is looking for high energy, driven, passionate people, looking to not just change jobs, but start an amazing career!
 
Your responsibilities include:

• Evaluate and select suppliers based on their capabilities, quality systems, and adherence to industry standards
• Establish strong relationships with suppliers, fostering open communication and collaboration
• Assess supplier capabilities through direct on-site visits and technical discussions. Coordinate the evaluation of proposed changes at suppliers
• Evaluate and communicate quality issues to suppliers and apply sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation
• Collaborate with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents
• Identify and advise management on potential improvements to quality systems and processes in the company
• Champion 100% compliance to company policies and SOP’s
• Work closely with software development teams, quality assurance, regulatory affairs, and other stakeholders
• Participate in design reviews, risk assessments, and project meetings
• Drive continuous improvement initiatives within global supply chain
• Analyze data, track key performance indicators, and identify areas for enhancement
• Implement corrective and preventive actions to address quality gaps

 
Required Qualifications:

• Bachelor’s degree in engineering or a related technical field.
• Minimum of 2 years of experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.

Preferred Qualifications:

• Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing
• Experience in software quality assurance, supplier management, or regulatory compliance within the medical device industry
• Certification in quality management (e.g., ASQ Certified Quality Engineer) is advantageous
• Proficiency in relevant standards (e.g., ISO 13485, IEC 62304, FDA regulations)
• Strong analytical skills, attention to detail, and problem-solving abilities
• Excellent communication and interpersonal skills
• Domestic and international travel up to 20%

Requisition ID: 593454

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance 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.