Engineer II, Quality Systems

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

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 and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity, and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.

Hybrid Roles:

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

About the Role:

Provide Process/Quality Engineering support to quality system function, helping to ensure delivery of highest quality product or new products to the customer.

Your Responsibilities Include:

• Support, plan, conduct, and oversee internal system audits according to applicable regulation to assess the effectiveness of the QMS and identify areas for improvement.
• Maintain audit records, findings, and corrective actions.
• Follow-up deadlines of planned corrective and preventive actions plans, and initiate escalation when necessary.
• Generate reports on quality performance and trends, providing insights to management for decision-making.
• Collaborate with cross-functional teams to identify areas for process improvement and implement corrective and preventive actions (CAPAs).
• May act as CAPA Coordinator for the site. Provide guidance to owners about CAPA process and eCAPA system. Conduct CAPA Review Board and report required information to different forums.
• Support external audit readiness and participation on external audit scheduled for the site.
• Work closely with the business system process owners to drive continuous improvement.
• Use data analysis and key performance indicators (KPIs) to drive continuous improvement initiatives within the industrial sector.
• Improve, develop and deliver training programs related to the QMS specific, ensuring that employees understand and adhere to quality standards and procedures.
• Serve as a SME for Control of Documents, Internal Audits, Management of Non-Conformities, Problem Solving, Management Review and Training for IDL.
• Stay current with industry trends, regulations, and best practices to ensure the company's quality systems are up to date. Give input for continuous improvement strategies to support the organization’s manufacturing quality, cost reduction goals and standardization of processes.
• Understand and track quality plans, documents and systems by reviewing product and process specifications and quality systems requirements.
• Conduct onboarding training sessions for new employees.
• Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining and improve of quality system.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, etc.
• Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's.

What We’re Looking For:

• Bachelor's degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
• English Level: B2:(70-79%).
• Desired knowledge: ASQ certification (CQE, SSGB) desired, ISO standards, MDSAP, medical devices regulation.
• At least 2 years of experience in similar position.

Requisition ID: 588452

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.