Global Design Quality Assurance Manager
The Global Design Quality Assurance Manager has the responsibility to assure the quality of product design from development through manufacture and commercial distribution for all new and upgrade products developed. The successful candidate will assure product designs provide the necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market for new innovations as well as cost effectiveness. The Design Quality Assurance Manager is responsible to develop and implement a design quality strategy that supports the overall quality strategy as well as the key Business goals.
- Provide design assurance oversight to all functions operating in the New Product Introduction area.
- Define clear roles and responsibilities for all functions to ensure effective execution of the design controls process (R&D, RA, PM, Operations, Clinical).
- Ensure timely communication with VP of QA and Senior Leaders on critical design quality
- Conduct/Coordinate regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects.
- Ensure that product / process / package / label/ Test Method designs and associated documentation comply with applicable Regulations for products distributed globally.
- Pro-actively monitor Post Market surveillance trends to ensure any potential design issues are addressed as well as developing a closed loop feedback system to the design process.
- Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process.
- Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission
- Establish and execute design control policies, procedures, processes and principles to ensure robust product designs, appropriate evaluation during development and document change controls compliant with requirements.
- Collaborate with R&D in the development of Design test protocols and study plans and ensure both test plans and reports are compliant with all applicable regulatory requirements.
- Work with R&D to ensure that Product Test Methods are designed to provide the appropriate challenge to products and validated appropriately.
- Work with R&D to ensure successful and cost-effective product scale-up and technology transfer from R&D to commercial manufacture.
Bachelor's Degree - Engineering/Science/Life Sciences - Post graduate degree desirable.
Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast-moving R&D environment.
Experience managing a design assurance team is essential and preferably experience working with teams remotely.
Strong Leadership capability and ability to influence change balancing compliance with pragmatic problem solving.
Proven track record in delivering successful NPI programs on budget and on time.
Proven track record in delivering Continuous Improvement programs.
- Ability to work and interact with several cultures across various time zones.
5 years plus experience in a QA/R&D 0r other Technical leadership role in a regulated environment.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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