Engineer II, Quality Systems

Reclutador/a: Melissa Barquero Sandi

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

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

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:

Manage the activities related to Internal Quality Audits to ensure compliance with local and corporate requirements. Ensure the audit program is conducted effectively and efficiently in accordance with regulatory and ISO 13485 standards. Provide support to other Quality Systems activities as needed, including Quality Planning, External Audits, CAPA, and Management Controls sub‑processes.

Your Responsibilities Include:

• Provide guidance for auditors as necessary.
• Organize, plan, direct and control in an efficient manner the activities of the internal quality audit process.
• Propose or contribute with initiatives of continuous improvement in the internal quality audit system.
• Assures the implementation of new corporate requirements related to internal quality audit system.
• Review, examine, approve and recommend changes on local procedures and other related documents to assure compliance with corporate, regulatory and ISO 13485 requirements.
• Attend global conference calls and meetings related to the internal audit process.
• Follow up on audit responses as required.
• Perform quality audits to ensure compliance with regulations and ISO 13485 requirements.
• Manage BSC Costa Rica audit team.
• Could provide regulatory training (QSR, GMP, auditor training, Audit readiness among others) or support department trainers.
• Manage and/or support audit backroom activities during external audits.
• Give support to environmental or safety audits.
• Provide support on audit related topics to all BSC Costa Rica users.
• Perform administrative work for audit department in order to keep and implement BSC Costa Rica Audit Program.
• Give support to Supplier audits as required.
• Assure quality records generated from internal and external audits are kept per site requirements.
• Contact Global Audit and other audit departments within the corporation.
• Create/ generate plans and reports as required.
• May lead audit readiness activities.
• Provide support to Management Review, External Audits, CAPA/NCEPs, Quality Planning processes if required.

What We’re Looking For:

Bachelor's degree in engineering, biotechnology, microbiology or a related field.

• English Level desired: B2+ or above.
• Experience:

• Internal audits execution.
• 2+ years’ experience in quality positions in the medical device industry with a solid understanding of QSR/QMSR and ISO 13485 Quality System requirements.

• • Excellent verbal and written communication skills.
  • Proficiency in MS-Office (Word, Excel, PowerPoint, Project, Visio).
  • Project/task management experience.
  • Experience with nonconformance and/or CAPA process.

Preferred Requirements

• Lead Auditor Certification ISO 13485 Quality System.
• Experience with Product Lifecycle Management systems (i.e. Windchill, PLM).
• Experience with AI tools (MS Copilot, ChatGPT) and/or data management dashboards (Power BI, Tableau).

Internal Candidates:

• At least one year in current position.
• Performance Evaluation: Successful or above.
• Don't have disciplinary actions in the last 6 months.

 Númerode la requisición: 621712

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.

#CRTA #CYLTA