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Lead Quality Engineer
2 months ago
Position Title
Quality Lead
Project Duration
6 months to 1 year (Tentative, may extend)
Industry
Mechanical/Bio Medical
Role Overview
The Quality Lead will collaborate with the strategic network project team to facilitate the integration of product families.
This role involves partnering with New Product Development (NPD), Manufacturing Engineering, and various cross-functional teams to ensure the appropriate application of design controls, risk management, and validation of processes and testing methods in accordance with established procedures.
Key Responsibilities
- Support the formulation of quality strategies pertinent to the transfer of products, materials, and components.
- Provide guidance, mentoring, and performance evaluations for project quality engineers.
- Approve Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), or Software Validation.
- Implement risk mitigation strategies.
- Engage in strategic planning with project leaders and the Manufacturing Engineering team, collaborating with other functions to prioritize business needs and allocate resources effectively.
- Ensure the development of robust quality strategies for the validation of testing methods and processes.
For those in supervisory roles, it is essential to ensure that team members adhere to all company guidelines regarding Health, Safety, and Environmental practices, and that necessary resources are available and maintained.
Essential Skills
- Quality Management strategy definition and implementation - Good
- Collaboration, Mentoring, Coaching, and accountability across all levels of quality functions - Good
- Knowledge of CAPA, PFMEA, Control Plans, and Lean Six Sigma methodologies - Good
- Understanding of manufacturing processes relevant to medical devices - Good