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 External Operations 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!

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 is not available for this position at this time.

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

Your responsibilities include:
Supplier Management:
⦁    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.
Quality System Champion:
⦁    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.
Cross-Functional Collaboration:
⦁    Work closely with software development teams, quality assurance, regulatory affairs, and other stakeholders.
⦁    Participate in design reviews, risk assessments, and project meetings.
Continuous Improvement:
⦁    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
⦁    Certification in quality management (e.g., ASQ Certified Quality Engineer) is advantageous.
⦁    Proficiency in relevant standards (e.g., ISO 13485, IEC 62304, FDA regulations).
⦁    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.
⦁    Strong analytical skills, attention to detail, and problem-solving abilities.
⦁    Excellent communication and interpersonal skills.
⦁    Domestic and international travel up to 20%
 

Requisition ID: 603135 

Minimum Salary: $ 69500 

Maximum Salary: $ 132000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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.

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 status, age, mental or physical disability, genetic information or any other protected class.

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.

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