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Quality Assurance Engineer II – 12‑Month Temporary Role
Boston Scientific · Alajuela
Description du poste
About the role
Boston Scientific is seeking a Quality Assurance Engineer II for a 12‑month fixed‑term assignment. The role focuses on complaint handling and post‑market surveillance for moderate‑complexity medical products, working in a hybrid environment that combines remote and onsite activities.
Key responsibilities
- Complete monthly complaint signal evaluations and coordinate with reviewers, approvers, and data analytics partners.
- Approve complaint investigations in line with corporate and regulatory requirements.
- Maintain the complaint backlog within defined performance targets.
- Support NCEPs, CAPAs, complaint review boards, and related compliance actions.
- Contribute to product transfer projects, new product introductions, and lifecycle initiatives.
- Act as subject‑matter expert for assigned moderate‑complexity products.
- Participate in complaint reduction, continuous‑improvement, and divisional projects.
Required profile
- Bachelor’s degree in Engineering or a related field.
- Minimum of 2 years of relevant experience in the medical industry.
- English proficiency at B2–B2+ level (70‑89%).
- Knowledge of quality systems and regulatory requirements.
- Ability to produce technical documentation and perform data analysis.
Required skills
- Complaint handling
- Post‑market surveillance
- Trend analysis
- Quality systems knowledge
- Regulatory requirements knowledge
What we offer
- Hybrid work model with flexibility to work from home and onsite.
- Opportunity to contribute to patient safety and product quality.
- Experience in a global, innovative medical‑device environment.
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Boston Scientific
Alajuela