Quality Assurance Engineer II - (Temporary 12 months)
Propark Free Zone, Coyol de Al, A, CR
Additional Locations: N/A
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 on 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:
The Engineer II, QA (Complaints) is responsible for supporting complaint handling and post-market surveillance activities for assigned moderate complex products. This role owns the monitoring of product quality performance through complaint trend analysis, signal evaluations, and investigation approvals, ensuring compliance with corporate policies and regulatory requirements. The Engineer I collaborates with cross-functional teams to identify quality risks, drive continuous improvement initiatives, and support actions that enhance product quality, patient safety, and customer satisfaction.
Key Responsibilities:
- Complete assigned monthly complaint signal evaluations (SEF), coordinating with reviewers, approvers, and data analytics partners.
- Approve complaint investigations for multiple products in alignment with corporate and regulatory requirements.
- Maintain complaint backlog within corporate-defined performance targets.
- Support NCEPs, CAPAs, complaints review boards activities, and complaint-related compliance actions.
- Contribute to Product Transfer Projects (PTPs), NPIs, and lifecycle initiatives.
- Act as SME for moderate-complexity products.
- Support New Product Development or Transfer activities for Complaints Investigation Site.
- Participate in complaint reduction initiatives, continuous improvement efforts, and divisional projects.
- Collaborate with cross-functional partners to resolve quality and complaint-related issues.
Required Qualifications:
- Bachelor's Degree in Engineering or related field.
- Minimum 2 years of relevant professional experience in the medical industry
- English proficiency: B2–B2+ (70–89%)
- Knowledge of quality systems and regulatory requirements.
- Technical documentation and data analysis capabilities.
Preferred Qualifications:
- Participation in continuous improvement, Lean, Kaizen, or VIP initiatives.
- Experience training, mentoring, or influencing peers and junior technicians.
- Complaint handling and post-market surveillance experience.
- Experience developing and modifying regulated documentation, such as work instructions, procedures, and quality system documents, in compliance with applicable regulatory requirements.
Requisition ID: 631352
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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