Quality Engineer III

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles: 

Boston Scientific's hybrid workplace includes Working from Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role:

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems.

This role provides site‑level NCEP coordination, oversight, and approval support across the quality system. The NCEP Coordinator partners with NCEP owners, project teams, and Quality leadership to ensure timely, compliant, and effective investigations and corrections, while driving continuous improvement and risk reduction.

Key Responsibilities:

Key responsibilities include, but are not limited to, the following:

• Checks and provides support in the execution and investigation of NCEPs.
• Tracks and monitors the progress of open NCEPs, ensuring all deadlines are met and actions are completed and documented according to procedures.
• Provides mentorship to NCEP owners and/or teams of the NCEP process.
• Supports opportunities for improvement.
• Reviews and approves NCEP records as needed, ensuring that proposed corrections are appropriate, and sustainable, and compliant with requirements. 
• Provides support for day-to-day eCAPA activities (training, access, system issues, etc.).
• Participates in NCEP Community of Practices as applicable to share best practices and disseminate information to the site.
• Identifies and resolves complex exceptions to work assignments.
• Continually seeks to drive improvements in product and process quality.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decisions on a daily basis utilizing the quality manager/site QA Director as the final arbitrator on critical quality decisions.
• Uses knowledge of Problem Solving principles to review investigations and improve quality.
• Gives technical guidance to Associate Quality Engineer as needed.
• Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• Is familiar with the internal auditing process.
• Provides support during internal and external audits.
• Participate in projects as needed.

Required Qualifications:

• Bachelor's degree required.
• Minimum of 3 years of experience supporting nonconforming events within a regulated environment.
• Experience working in regulated industries (e.g., FDA, ISO standards, EU MDR, ISO 13485).
• Demonstrated experience leading or mentoring cross‑functional teams through nonconforming events.
• Strong written and verbal communication skills with a high level of attention to detail.
• Proven problem‑solving, organizational, and execution skills.
• Advance English Level

Preferred Qualifications:

• Broad working knowledge of quality systems and processes (e.g., CAPA, NCRs, audits, complaints).
• Quality‑related certifications (e.g., ISO 13485, AS9100).
• Subject‑matter expertise in nonconforming event management.

Requisition ID: 624739

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!

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.