Design Quality Manager at Boston Scientific Corporation Malaysia

La Asunción, Cantón de Belén, Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

0.0

Posted On

17 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Controls, Risk Management, Post-Market Surveillance, Quality Assurance, Technical Strategies, Problem-Solving, Cross-Functional Collaboration, Documentation, Team Leadership, Medical Device Industry, ISO 13485, ISO 14971, 21 CFR 820, Diversity and Inclusion, Electrophysiology Products, Product Performance

Industry

Medical Equipment Manufacturing

Description

Additional Locations: Costa Rica-Heredia 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 Boston Scientific is recruiting for a Design Quality Assurance (DQA) Manager at our Heredia site in Costa Rica. This exciting role involves leading a team of skilled engineers within the Pulse Field Ablation franchise to ensure product quality and compliance by applying Design Control and Risk Management processes. This role will support one of the key areas for electrophysiology products: sustaining activities including product performance and improvement projects. The role is hybrid with the expectation to be on-site 3 days a week. Your responsibilities will include: Lead and develop a team of Design Quality Assurance Engineers who support sustaining product and projects of significant magnitude and scope. Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Own and drive deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance. Review and/or approval of documents, investigations, or another regulatory figure within the company's quality system. Provide guidance regarding technical strategies and approaches; work cross-functionally in identifying and resolving technical issues. Maintain and enhance cross-functional team relationships with key partners in Research & Development, Process Development, Regulatory, Operations, the broader Quality organization, and others as required. Generate, review, and approve documentation in the document control system. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality and project issues. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Influences others to build collaborative relationships, achieve goals and effectively guide them to understand more complex issues. What we're looking for in you: Required qualifications Bachelor's degree and a minimum of 7 years of relevant work experience or an equivalent combination of education and work experience Experience with Design Controls, Risk Management and Post-Market Surveillance activities Ability to travel internationally as requested 1+ years of direct or indirect supervisory experience English Level required: C1:(90-94%). Please submit Resume in English Preferred qualifications: Advanced degree in technical field Experience leading technical teams Experience in the medical device industry Use and understanding of regional and international quality system requirements including ISO 13485, ISO 14971, 21 CFR 820 Requisition ID: 614369 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. CRTA | ---|--- HRDTA | MANCR |

Responsibilities

Lead a team of Design Quality Assurance Engineers to ensure product quality and compliance. Drive deliverables related to Design Controls, Risk Management, and Quality initiatives.