Senior Quality Assurance Specialist
We are seeking a highly skilled Senior Quality Assurance Specialist to support our commercial projects from a Design Assurance perspective. You will be directly involved in ensuring our products meet global standards and comply with regulatory requirements throughout the entire product lifecycle.
You will assess patient risk associated with design changes, provide QA technical direction/input to qualification and validation activities, and contribute to the generation of Design Verification protocols. Additionally, you will participate in the compilation of design verification and shelf life data for regulatory submissions and collaborate with Regulatory Affairs to ensure clear presentation of information.
As a key member of our team, you will establish strong working relationships across the organization and with partners within a complex technical environment. You will maintain expert knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities.
Responsibilities:
* Support sustaining commercial projects from a Design Assurance perspective.
* Assess patient risk associated with design changes.
* Provide QA technical direction/input to qualification and validation activities.
* Contribute to the generation of Design Verification protocols.
* Participate in the compilation of design verification and shelf life data for regulatory submissions.
* Collaborate with Regulatory Affairs to ensure clear presentation of information.
* Maintain expert knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities.
Required Skills and Qualifications:
* Level 8 Engineering Degree.
* 4+ years experience in Quality/Design Assurance/R&D Engineering in the Medical Device Industry.
* Experience with risk management, change management, and product/process/materials changing.
* Skills: Quality Engineer, Quality Medical Device Engineering.
Benefits:
* Opportunity to work with a leading medical device company.
* Competitive salary and benefits package.
* Ongoing professional development opportunities.
Others:
* Specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
* Collaborate with complaints team for complex investigations.
* Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO, and ANSI/AAMI/ISO requirements.