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Quality Assurance and Regulatory Lead
1 month ago
We are seeking a Quality Assurance and Regulatory Lead to join our team at Philips.
About the RoleThe Quality Assurance and Regulatory Lead will be responsible for formulating and implementing the company's long-range quality, regulatory, and compliance policy. This includes leading and directing organizational development and process improvement to ensure that strategic policy and growth targets are met.
Key Responsibilities- Formulate and implement the company's quality, regulatory, and compliance policy.
- Create quality awareness levels within the organization.
- Enforce quality systems across the company sites and sector, establishing an effective management review process.
- Introduce and implement quality processes and tools to ensure product quality and customer satisfaction.
- Manage compliance with FDA regulations and other regulatory agencies.
- Review and approve finished products manufactured by the company.
- Manage inspections and questions related to product development.
- Support product recall activities and audit programs.
- 15 years of experience in product development in regulated industries, such as medical devices with electro-mechanical products with embedded systems.
- 5 years of experience managing teams of engineers, with understanding of regulations and standards used in medical device design and development activities.
- Experience with FDA inspections/ISO audits is desired.
- Engineering professional with a bachelor's or master's degree in electrical/mechanical engineering.
This is an onsite role that requires full-time presence in the company's facilities. We offer a competitive salary and benefits package.
The estimated salary for this position is $120,000 - $150,000 per year, depending on experience and qualifications.
