Q&r Manager

hace 6 días

Alajuela, Costa Rica Philips A tiempo completo

**Job Title**: Q&R Manager

Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business and site.

**Responsibilities**
- Manage a team of supervisors, complaint investigators and inspection teams (Receiving, in process and final inspections).
- Monitor daily work operations and provides direction and guidance to team members and/or project teams.
- Support new product development and/or design changes in coordination with management, project leaders, & project team.
- Oversee, own, review and approve procedures and work instructions, **nonconformance's, complaint investigations, inspection records, and CAPAs, as applicable.**:

- Position will assure that products, materials, and components will be reviewed, tested, inspected, recorded, qualified, and released.
- Position will ensure that complaints are investigated in a timely manner and in accordance with regulations and Philips procedures.
- Position will provide training to team and manufacturing as needed
- Position will participate in audits with regulators, agencies, and auditors such as FDA, Competent Authorities and notified bodies. And support post market surveillance and recall activities, as needed.
- Lead succession planning and development planning for team.

**Requirements**:

- Advanced English
- Bachelors or master’s degree required, Engineering or Science preferred
- Typically requires a minimum of 8+ years of FDA regulatory industry required (Medical Devices, Pharmaceutical, or combination thereof)
- CQE, CBA, or CQA are preferred
- Must have demonstrated ability to work with senior leaders and be able to engage/influence cross functional leadership teams
- On site

**About Philips**

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.

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