Additional Locations: Costa Rica-Coyol

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 Working From Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role

This is a high visibility, high impact Quality Manager role leading a team of Quality Engineers and Investigators that are responsible for the effective and efficient monitoring of BSC global product field performance. The team has primary responsibility for identifying signals utilizing multiple systems to mine data, analyze rates, and predict future performance. The team has extensive experience and knowledge of the transactional, reporting, and analytical software. The Quality Manager empowers the team to create, maintain, and validate the necessary tools for completion of these tasks. The Quality Manager will work across multiple organizational functions including Regulatory, Compliance, R&D, Design Assurance, Medical Safety, and the CAPA Management teams.

Your responsibilities include:

Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources. Translates department goals into individual objectives and IDP activities. Develops direct reports by securing appropriate training, assigning progressively challenging tasks, and conducting formal written and verbal performance reviews. Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures. Provide vision and plans for future improvements. Actively work with all other BSC Complaint Investigation locations to ensure effective implementation of best practices. Works closely with the IT organization to resolve any issues, plan future upgrades, and assess new tools. Facilitate the monitoring of new products and their performance during early commercial release. Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO, regulations etc.) especially with regards to tool development and validation. Contributes to the development and monitoring of area budgets through regular analysis of cost and spending. Identifies, develops, and implements new procedures and/or improve existing procedures in order to improve department performance and facilitate and assure regulatory compliance. Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings. Review and/or approval of documents, investigations, extensions or another regulatory figure within the company´s quality system, as an alternate representative of Quality Management. May participate as a core team member in the new products transfer process, representing Quality Assurance areas. May act as NCEP System administrator for the area: tracking and keeping NCEP investigations related to the area closed; area NCEP owner; perform continuous improvements in NCEPs for the area; coordinate with other NCEP administrators on actions executes and the impact on other areas. May participate in the PIR (Product Inquiry Report) process, assuring: diligent execution of activities related to the PIR, PIR assessment in the eCAPA system, PIR execution, and appropriate process communication to Corporation.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Required Qualifications:

Bachelors or Licentiate degree in Industrial Engineer or Field Related. English Level desired: C1:(90-94%). experience on managing regulations for medical device industry, ie ISO13485 & QSR 820 Process control knowledge is a must. Experience managing people is a must. At least 7 years of experience in similar position. QS Integration knowledge and/or management is a plus QS and regulatory strategy for product transfer is a plus Please submit Resume in English

 

 

 

Requisition ID: 599889

 

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.