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Senior Manager of Quality Systems
4 months ago
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
This position will have responsibility for the end-to-end process related to product quality issue investigations through the decision-making framework of risk management, quality review boards and field action execution while incorporating worldwide standards and regulations. Additionally, the position will have responsibilities for identifying improvement trends to present opportunities to top management and direct report supervision, performance and development planning for the team
Key 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 will:
- Drive operational excellence of product investigations and field action processes under applicable J&J procedures and regulatory requirements.
- Manage Ethicon teams responsible for scheduling, coordination and preparation of Product Issue Escalation and Quality Review Board (QRB) Meetings.
- Oversight of the department's budget, hiring, retaining and developing qualified personnel, as well as resolving all personnel issues and employee performance management.
- Provide support to internal and external audit processes. Serve as SME in responsible areas for internal and external audits.
- Monitor key process metrics for product issue investigation and field actions, communicate status and find opportunities for process improvements across MedTech organizations.
- Support OUS affiliates, with monitoring of field action reporting through action closure, identifying process improvements to ensure timeliness closures.
- Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR) as well as all other applicable global regulatory requirements.
- Act as a representative for J&J Medical Devices to US FDA, worldwide health authorities and notified bodies, as applicable.
- Communicate business-related issues or opportunities to next management level.
- Lead field corrective actions, any associated regulatory actions and follow-ups; lead in product problem resolution as part of follow-up from QRB and CAPA.
- Supervise technology platform supporting the product issue investigation, quality review board, and field action processes to ensure compliance to regulations and standards and effective internal process flow.
- Participates and stays well-informed of enterprise solutions and their impact to emerging field action and product quality issue internal and external standard changes.
- Establishes and maintains training programs to implement field actions with required partners to effectively determine product quality issue resolution.
- Responsible for communicating business related issues or opportunities to next management level.
- For those who supervise or lead staff, 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.
- Additional responsibilities as assigned and needed.
