This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Quality Risk Management Leader
Philips - Gainesville, FL
posted 2 months ago
About the position
The Quality Risk Management Leader at Philips will oversee Quality Management System (QMS) activities and projects for the Enterprise Informatics business across multiple global sites. This role involves formulating and implementing long-range Risk Management policies, ensuring compliance with FDA regulations, and driving improvements to meet strategic growth targets. The leader will harmonize quality systems across business sites, manage product safety risk assessments, and interact cross-functionally with stakeholders to enhance product quality and customer satisfaction.
Responsibilities
- Enforce simplified quality systems and harmonize them across supported business sites.
- Manage compliance with FDA regulations and other regulatory agencies.
- Interact with all areas involved in the product development process to provide direction and consultation.
- Ensure product safety risk management deliverables are created, approved, and maintained by top management.
- Monitor and report on products' safety risk management performance in the field.
- Perform detailed quality engineering tasks such as assessing product designs and reviewing test data.
- Support efforts to improve effectiveness and efficiency of the post-market process.
- Identify opportunities for process improvement through statistical analysis and critical thought.
Requirements
- 10+ years of experience in Quality Management and Risk Management.
- Experience leading audits and working independently as a decision-maker.
- In-depth knowledge of medical device industry standards such as ISO 13485 and ISO 14971.
- Experience with Corrective and Preventive Actions (CAPAs) and audits in a medical device setting.
- Bachelor's degree in a relevant scientific or engineering field or equivalent relevant experience.
Nice-to-haves
- Strong product knowledge in the medical device industry.
- Ability to influence without expressed authority.
- Strong accountability for results achieved.
- Passion for patient safety and quality.
Benefits
- Generous PTO
- 401k with up to 7% match
- HSA with company contribution
- Stock purchase plan
- Education reimbursement
- Annual incentive bonus
