Quality Engineer II

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 manufacturing sustaining, product transfer or new product development teams, helping to ensure delivery of highest quality product or new products to the customer.

Your Responsibilities Include:

· Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.

· Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.

· Key contributor to process risk analyses execution and reviews. May own process risk files creation.

· Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development

· Learns Quality Tools & Training Materials by gaining knowledge of tools used and by reviewing & utilizing available training materials.

· Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

· Evaluates new equipment and processes and participates in the transfer of new products.

· Get involve in various stages of equipment and processes validations: Run and/or review and approve reports: TMVs, I.Q 's, O.Q's and P.Q's as well as any other document relating to validation.

· Read and interpret technical drawings, procedures, and protocols

· Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.

· Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, supporting decision making on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.

· 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 required: B2:(70-79%).

· Desired knowledge: process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods, Scientific tools (e.g. Gage R&R, DOE, process capability).

· Desired knowledge in Product and Process Transfer and Project Management.

· ASQ certified desired.

· At least 2 years of experience in similar position.

Requisition ID: 610659

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!