**Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Location(s)**: Costa Rica-Coyol**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 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 Director of Plant Quality for Cartago leads a team of Managers, Senior Engineers, Engineers, Technicians, and other professionals to ensure full compliance to all GMP/QSR practices and standards as defined by the Food and Drug Administration, ISO and other regulatory bodies.
In all actions, he/she/they will demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. He/she/they will interface with the Operations, Research & Development, and Regulatory Affairs functions to accomplish quality objectives. He/she/they will establish quality systems and plans to assure design and manufacture of the highest quality products. He/she/they will interact with outside regulatory agencies as a Boston Scientific representative.
**Your responsibilities include**:
- Providing leadership and direction to his/her team and ensure a Quality Management System exists to meet the various requirements of a medical device manufacturing facility. Specifically, he/she/they will ensure that the necessary monitoring of and management of processes including storage, retention and review, establishment of internal auditing programs, verification of all products and processes to the established quality standards and validation of new products/processes or changes to existing products/processes.
- Building strong and sustaining relationships with internal colleagues and functions including Production, Engineering, Corporate Quality, Regulatory, divisional stakeholders and others as needed.
- Interfacing and building effective communication and relationships with external Regulatory bodies.
- Demonstration of commitment to developing people and recognition as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in his/her/their everyday leadership style.
- Demonstration of effective change leadership capabilities, and recognition as a team player across the organization.
- Ensuring the BSC Quality Management System is fully implemented to comply with requirements.
- Ensuring that the necessary monitoring systems are implemented, and signals responded to for production & process controls, document and records controls, design controls, material and supplier controls, post market feedback, product approvals and CAPA.
- Directing and control the Quality budget in collaboration with relevant stakeholders.
- Communication of quality policies, strategies and procedures to the organization through written documents, presentations and discussions.
- Monitoring and ensuring compliance with company policies and procedures (e.g. federal/country and regulatory requirements)
- Continuously fostering and driving a continuous improvement approach to Quality and ensuring that quality is the responsibility of everyone.
- Ensuring that the Quality System is an integrated and integral aspect of the total running of the Site.
**Required Qualifications**:
**Minimum Qualifications**:
- **Bachelor's degree in Engineering/Science/Technical, plus 9-12 years of related work experience or an equivalent combination of education and work experience**:
- 6-8 years of experience leading a large team/organization
- **Experience in the Medical Device Industry**:
- **Experience in managing large-scale, complex operations/programs/projects**:
- Excel in Collaborative Leadership
- Experience in Quality Systems and methods
- Collaborative Individual with the ability to influence
- English Level C1+ 90%-99%
- Please submit Resume in English
**Preferred Qualifications/Skills**:
- Advanced degree
- Lean business/VIP experience
- Experience leading teams in a site quality setting
- Leading culture advancement and results in technical problem solving
- Financial experience in cost center pla
