Design Assurance Manager

 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 WFH and onsite. You will have the opportunity to discuss details in the interview. 

About the Role:

The Quality Manager is responsible for designing, planning, coordinating and executing projects oriented towards quality improvement in the site. Establishes and maintains Quality Management systems that meet regulatory requirements, corporate policies, internal policies and business needs. Additionally, he/she is responsible for planning and supervising Quality Engineering functions and activities.

Your Responsibilities Include:

• Plan, coordinate and execute projects oriented towards process defects prevention and overall quality improvement.
• Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management.
• Provide technical support to the Quality area and to other departments.
• Coordinate Quality Engineering functions and activities.
• Deliver training related to quality technologies.
• Coordinate with Corporation the implementation of projects related to the Quality dpt.
• Create new procedures and/or improve the existing in order to facilitate and assure regulatory compliance.
• Responsible for acting as Subject Expert Matter (SME) of the following chapters of the company´s quality system: 803.5 Individual Adverse Event reports, 820.70 Production and Process Controls, 820.75 Process Validation, 820.60 Identification, 820.65 Traceability, 820.72 Inspection, measuring and test equipment, 820.90 Non-conforming product, 820.80 Receiving, in-process and finished device acceptance, 820.100 CAPA, 820.198 Complaint Files.
• Provide support to new products/process transfer projects
• May design and implement process control strategies.
• May facilitate and support the Quality Control supervision function through Quality Engineers and Quality Supervisors.
• May participate as a core team member in the new products transfer process, representing Quality Assurance areas.
• May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area MRB administrator; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executes and the impact on other areas.
• May participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation. May act as the Quality Director (Head of Quality) designee in PIR process activities.
• May provide guidance and supervision to process validation areas, software validation, complaint handling, MTAC, Calibration, Microbiology, supplier, Q process development,  and/or design assurance.

What We’re Looking For:

• Licenciature degree in Industrial Engineer or Field Related.
• English Level desired: C1:(90-94%).
• Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified, Knowledge of Six Sigma, Lean, APQP or similar tools.
• Experience on managing regulations and complaints MDR / MDV.
• Experience managing people is a must.
• At least 7 years of experience in similar position.

Requisition ID: 588347

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.