Act as a member of the Boston Scientific Cork facility quality team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
Responsibilities
- Ensure continued compliance to all applicable regulatory standards, cGMP procedures and practices are maintained
- Manage CAPA/NCEP activities for the Cork Site, acting as a liaison between Quality Systems and Manufacturing.
- Responsible for coordinating, presenting and disseminating the minutes for CAPA Review Board
- Responsible for proactively identifying and addressing any Quality/Compliance risks within BSC and ensuring that appropriate action is taken
- Provide mentorship to CAPA owners to ensure compliant and timely records through sound problem-solving practices and scientific methods
- Complete trend analysis and capture metrics for reports including CAPA Review Board, Management Review, MRB & Non-Conforming Records and CAPA Records
- Responsible for tracking, trending & communication of various elements of the Quality System including but not limited to CAPAs, Internal Audits, and Quality Incidents
- Act as local SME on all related procedures, ensuring compliance to the relevant Global and Corporate procedures
- Collaborates with members of the CAPA community from all sites to deliver process improvements for the global CAPA processes
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communication, and resolving quality issues.
- Oversight of the Doc Issuance process on site and act as Cork liaison with Galway/Global Doc control for assigning Document Owners and ensuring annual documentation review is completed on time.
- Ensure adequate training is developed and provided to all users on the CAPA/NCEP system and relevant problem solving tools.
- Drive continuous improvement activities within the Quality System Department. Oversight of CI board for Quality systems and VIP activities for Quality departments
- Participate in the Internal Auditing Programme
- Participation in External Audits including FDA, DEKRA, and Corporate Audits
- Provide quality support and guidance to infrastructure teams such as Facilities, Calibration and Equipment Engineering on quality related issues including NCEP & CAPA
- Develop and enhance the compliance culture within BSC and ensure that compliance is deployed to all levels of the Organisation
- Participate in multi-functional teams set up to drive Quality.
- Support the preparation of documentation for regulatory submissions
About us
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Educational & Experience Requirements
- Minimum of Bachelor of Science Degree in Engineering/Technology
- 2/3 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
Educational & Experience Requirements
- Minimum of Bachelor of Science Degree in Engineering/Technology
- 2/3 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
