Engineer, Prin Quality Job

hace 9 horas

Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

**Engineer, Prin Quality Job**:

- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: N/A

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance**

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
With access to the latest tools, information and training, we'll help you in advancing your skills and career.
Here, you'll be supported in progressing - whatever your ambitions.
**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**:

- Licenciature degree in a STEM related Field
- 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.
- 1 year or more in current position.
- Annual Performance evaluation rating "Meets Expectations" or "Exceeds Expectations".
- At least 7 years of experience in similar position

**Requisition ID**:538456

**Job Segment**:Quality Engineer, Manufacturing Engineer, Compliance, QA, Quality Assurance, Engineering, Legal, Quality, Technology

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