Engineer, Prin Quality Heredia
hace 2 semanas
Additional Location(s): Costa Rica-Heredia
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 compromise.
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 pre-market and post-market Design Quality Engineering support to ensure delivery of highest quality products to the customer.
Your Responsibilities include and may execute the following responsibilities:
- Demonstrates expert knowledge and application of Design Assurance, Risk Management, and Post-Market Surveillance.
- Represent the division on various global CoP quality system improvement projects by proactively soliciting input from stakeholders, reviewing proposals to assess impact on EP, and advocating for EP needs amongst global counterparts.
- Potential to own quality system NCEPs, CAPAs, and project plans relating to Design Assurance and Risk Management.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Successfully navigates in grey spaces and provides logical and creative guidance to teams.
- Works with internal customers who represent related and interconnected processes such as Management Review, Design Controls, Risk Management, Cybersecurity, Post Market Surveillance, Clinical, Medical Safety, Regulatory, and Complaint handling.
- Be in compliance with all Corporate and applicable regulations related to complaint investigation management.
- Monitors regulatory submission & audit questions and responses, proactively communicates lessons learned to internal customers and assists teams with response writing for product and quality system-related questions.
- Supervise and provide support to the Design Quality Assurance team in activities related to PDP projects.
- Assist with engineering evaluations/generation and updates of procedures.
- Manage/improve systems and procedures from the Design Quality area.
- Coaches and mentors cross-functional team members in the application of the Design Control, Risk Management, and Post-Market Surveillance requirements for EP products
What We're Looking For:
- Bachelor degree or above in a STEM related Field
- At least 7 years of experience in similar position
- English Level required: C1:(90-94%).
- Desired knowledge: Formal training on statistical and quality techniques, desirable ASQ Certified.
- Experience on managing regulations and complaints MDR / MDV.
- Please submit Resume in English
Requisition ID: 584884
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.
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