Director of Quality Assurance
hace 1 semana
Job Summary: We are seeking a highly experienced and skilled Director of Quality Assurance to join our team at the Healthcare Businesswomen's Association. The successful candidate will be responsible for leading the development of product specifications, managing supplier relationships, and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement quality assurance strategies to ensure compliance with regulatory requirements
- Manage supplier relationships to ensure timely delivery of high-quality products
- Collaborate with cross-functional teams to develop and implement quality assurance programs
- Oversee quality system requirements (QSR) for assigned departments and ensure compliance
- Provide leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability
- Direct budgetary responsibility for one or more departments, functions, or major projects/programs
- Interpret and execute policies for departments/projects and develop recommendations for new policies or modifications to existing policies
Qualifications:
- Bachelor's degree in Engineering, Science, or Technical Field
- At least 7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries
- At least 4 years of management experience
- Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
- Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions
- Demonstrated ability to control and coordinate concurrent projects, competing priorities, and critical deadlines
- Advanced level skill in Microsoft Excel
Preferred Qualifications:
- At least 6 years of managerial experience
- At least 8 years of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries
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