Engineer, Prin Quality Heredia

hace 3 semanas

Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

**Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**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**:

- 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.

**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- **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.**Job Segment**:Quality Engineer, Risk Management, Compliance, QA, Quality Assurance, Engineering, Finance, Legal, Quality, Technology

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