Engineer Ii, Quality

hace 2 semanas

San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

**Engineer II, Quality**:

- Remote Eligible: Hybrid- Onsite Location(s): Heredia, H, CR**Additional Locations**: Costa Rica-Heredia

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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**:
The Quality Engineer II will be primarily focused on the execution of Post Market Reporting assessments (Periodic Safety Update Reports) including but not limited to all associated design control and quality system deliverables related with execution.
The Quality Engineer II identifies, analyzes, investigates, monitors, and documents trends at a product performance level for post marketing surveillance data.
He/she/they will identify, coordinate, and execute project priorities based on business and department objectives and at times at the Global BSC level to ensure Cardiac Rhythm Management products meet evolving standards in the European Union (EU) and globally.
He/she/they will be responsible for identifying and helping with continuous improvement projects related to product performance and the post market support processes.
**Your responsibilities include**:

- Lead project teams and franchises in the execution of Quality Deliverables including but not limited to Post-Market Surveillance Plan & Report, as well as collaboration on the execution of Clinical Evaluation Reports.
- Act as a lead team member in continuous improvement projects to ensure Post Market Surveillance reports are completed with efficiency and compliance.
- Act as team member in analyzing customer complaints, compliance events, clinical data and post marketing surveillance data by examining for patterns, trends and investigating when necessary.
- Act as a team member in relevant Communities of Practice regarding Post Market Surveillance activities with influence across multiple Boston Scientific divisions and departments.
- Lead in the investigation of potential and/or identified trends or data issues with cross-functional teams across division(s).
- Act as key team member in representation for regulatory audits and supporting government agency inquiries, and questions.
Provide guidance to assurance compliance to all relevant laws and regulations.
- Provides leadership and mentorship to junior staff; fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
**Required Qualifications**:

- Minimum of a Bachelors Degree in Mechanical, Electrical, or Biomedical Engineering, or related discipline
- Minimum of 2 years of related experience with design controls, post market and/or risk management
- 1 year at current position
- Annual Performance evaluation rating "Meets Expectations" or "Exceeds Expectations".
- Or an equivalent combination of education and experience

Preferred Qualifications:

- Medical device experience strongly preferred
- Strong communication (oral and written) and presentation skills
- Experience with Microsoft Office Suite, specifically Excel
- Focus on detailed work with emphasis on accuracy and completeness.
- Eager problem solver capable of driving items to closure and brainstorming areas for improvement.
**Requisition ID**:554434

**Job Segment**:Biomedical Engineering, Medical Device Engineer, Quality Engineer, Compliance, Engineering, Legal, Quality

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