Partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality.
Key areas of responsibility
* Develop quality assurance documentation to support new product development process and regulatory submissions.
* Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
* Partner with cross-functional project teams to lead product and/or process design and development activities.
* Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
* Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process mitigate those issues throughout the development process.
* Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
* Partner with Advanced Operations in the development of manufacturing processes for new products.
* Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
* Develop, review, and approve inspection plans, routers, and product drawings for new products.
* Support product design transfers to internal and/or external manufacturing facilities.
* Provide support and direction for other Quality Engineers.
* Evaluate predicate products for relevant quality issues that may impact new product development projects.
* Analyze and define critical quality attributes for product and process through risk analysis techniques. Participate in collection of initial market feedback on new products and address early concerns.
* Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
* BS in a science, engineering or related discipline.
* MS, CQE, or CRE preferred.
* Six Sigma Green or Black belt preferred.
* Minimum of 5 years experience preferred.
* Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
* Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
* Demonstrated ability to read and interpret CAD drawings. Experience in interacting with regulatory agencies (FDA, MoH,TUV, etc.) required.
* Thorough knowledge and understanding of US and International Medical Device Regulations. Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
* Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
* Demonstrated ability to advocate for product excellence and quality.
* Demonstrated ability to effectively work cross[1]functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing. Strong interpersonal skills, written, oral communication and negotiations skills.
* Strong in critical thinking and "outside the box" thinking.
* Highly developed problem solving skills.
* Strong analytical skills.
* Demonstrated ability to successfully manage and complete projects in a matrix organization.
* Demonstrated ability to work independently.
* Experience in working in a compliance risk situation.
* Computer literacy (including proficiency with Mini-Tab or similar analysis program).
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