Key role in ensuring medical device products meet highest quality and regulatory standards throughout product lifecycle.
The position involves playing a critical part in guaranteeing compliance with global regulations and quality standards.
Responsibilities:
* Provide Design Assurance expertise to ensure compliance with global regulatory and quality standards.
* Evaluate and support the implementation of product, process, and material changes within manufacturing operations. Conduct patient risk assessments related to proposed design changes.
* Offer Quality Assurance direction and technical input for qualification and validation activities in collaboration with R&D and Manufacturing Engineering teams.
* Generate and manage Design Verification protocols, and participate in the compilation and review of verification and shelf life data for regulatory submissions.
* Collaborate with Regulatory Affairs to ensure clear, accurate, and complete information is presented in submissions to minimize regulatory queries.
* Establish and maintain strong cross-functional relationships across R&D, Manufacturing, Regulatory, and other stakeholders in a complex technical environment.
* Stay current with evolving regulatory compliance requirements related to product design, development, and commercialization, and apply this knowledge to projects and initiatives.
* Lead investigation activities, root cause analysis, and timely resolution of quality issues related to design or process.
* Partner with engineering and manufacturing teams to ensure robust quality standards are implemented and maintained.
* Design or specify inspection and test methods, equipment, and quality assurance procedures. Conduct QA testing and statistical analysis as required.
* Ensure that corrective and preventive actions (CAPA) are implemented effectively and documented in accordance with regulatory and quality standards.
Qualifications:
* Bachelor's degree in Engineering, Science, or a related technical field.
* Minimum of 5 years' experience in a Quality Assurance or Design Assurance role within the medical device industry.
* In-depth knowledge of ISO 13485, 21 CFR Part 820, and other applicable global medical device regulations and standards.
* Demonstrated experience with design control, risk management, validation/qualification activities, and root cause analysis.
* Strong written and verbal communication skills; experience interfacing with regulatory bodies is a plus.
* Proficient in statistical tools and quality methodologies.