Director, Quality Systems & Digital Solutions
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
Responsible for implementing the Quality Systems strategy and execution within ABIOMED to include but not limited to Corrective Action/Preventive Action (CAPA), Non-conformances (NC), Quality Systems Management Review (QSMR), Product Escalation, Field Action Execution and Document and Change Control, and Quality System Training. The Quality System leader ensures the ongoing effectiveness and continuous improvement of the Quality Management System(s) within the ABIOMED franchise. In addition, they are responsible for communicating Quality Systems and Digital Solutions requirements of the ABIOMED franchise to the QS/DS Center of Excellence (COE) to shape and drive the business objectives.
This role has responsibility for direct organizational development and planning, creating, and implementing tactical business plans to meet Company and Corporate objectives, deployment and execution of policies and standards to ensure systems and products are in full compliance with applicable Corporate, MedTech Center of Excellence, Company, Local, Federal, and international regulations. Also, develop partnership and collaboration with Johnson and Johnson counterparts to ensure alignment and standardization of best practices. Provide guidance and support for department staff to ensure departmental goals and responsibilities are met. Ensure that systems are implemented to address compliance issues in a timely manner.
Principle Duties and Responsibilities :
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Maintains Franchise quality assurance standards, which adhere to Good Manufacturing Practices, Quality System and ISO regulations. Responsible for communicating business related issues or opportunities to next management level.
- Understands, interprets and influences regulatory requirements as they pertain to Franchise requirements such as: National Regulatory agencies (FDA, MDA, etc.), Standards organizations (ISO, IEC, AAMI, ICH, etc.), Notified bodies (MedCert, etc.)
- Represent or provide representation and inputs to the digital solutions team as part of our goals to automate our quality systems, integrate our data, and advance proactive quality. Participate in project ideation and any other data and digital transformation efforts impacting the Franchise Quality Systems and Digital Solutions organization.
- Participate and where required manage external regulatory agency and notified body assessments and inspections (example: FDA, ISO). Review and participate in issues and/or decisions related to assessments including pre-assessment and post-certification audit activities.
- Hires, retains and develops qualified personnel, as well as resolving all personnel issues and employee performance management.
- Manages execution to the Quality Systems including: Management Controls, Training, Document Control, Change Control, Training, CAPA and Non-Conformance across the Franchise businesses.
- Participates in the development of Franchise strategic plans to support organizational goals and provide guidance to functional areas concerning quality system development.
- Supports FDA, ISO, international Health Authority, and corporate inspections including: communication and coordination with regulatory agencies including US FDA Investigators, ISO-13485:2016 auditors, and J&J corporate organizations.
- Represent business as the Quality Systems Franchise lead for Quality Centers of Excellence, Supply Chain and R&D Quality Systems related initiatives.
- Understands and effectively manages budgetary requirements and resources
- Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
· BS in Engineering, Science, Business or Business Management, or Quality Systems Management is required. Graduate degree preferred but not required.
· Minimum of 8-10 years of related work experience; 5+ years of leadership experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical or other regulated industry.
· Extensive knowledge of FDA Quality System Regulation and ISO 13485 Standard is required. Familiarity with international regulatory frameworks and Health Authority requirements is required.
· Demonstrated ability to enroll and influence across functional areas.
· Experience in Quality Systems Development is preferred.
· Working knowledge and experience in managing third party inspections and negotiating with 3rd parties on compliance issues.
· Prior supervisory experience, including managing direct reports is required.
· Experience in international Medical Device regulations is preferred.
· Experience or certification in Lean/Six methodologies preferred
· Professional certifications (ex. CQE, CQM, CQA, sigma preferred.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.