Sr. Quality Engineer
Memphis, TN Posted: 8/27/2019
Our client is a global Medical Device company focused on extremities and biologics products.
This position is responsible for supporting cross functional demands related to product development and manufacturing transfer through all design and development life cycle phases. Performs engineering work requiring the application of design of experiments, statistical techniques and risk management. Applies engineering practices and techniques to specific situations, adjusts and correlates data, recognizes discrepancies in results and follows operations through a series of related detailed steps or processes. Position is responsible for implementation, review and maintenance for all procedures, work instructions and forms needed to ensure effective support of internal customers while maintaining compliance to all applicable regulatory requirements. This position will serve as liaison to Quality Assurance, Manufacturing, Product development and Regulatory Affairs on all topics of Quality. This position is responsible for assisting in the implementation of programs associated with product development/manufacturing transfer through all design and development life cycle phases.
Essential Job Functions:
- Represent Quality Engineering through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness.
- Develop, review and/or approve documentation associated with engineering activities including quality plans, verification/validation protocols and reports and update quality system and department procedures.
- Develop, review and/or approve product test reports, technical investigations plans, engineering reports, gage R&Rs, capability studies and related procedures which ensure statistical validity, adequacy and compliance to regulatory and corporate requirements.
- Develop, review and/or approve necessary quality instructions, inspection methods, such as custom gaging and overlays and operate within a CAD system to deliver these necessary items for inspection needs.
- Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving/improving quality issues.
- Attend and lead regular communication meetings with cross-functional teams at Wright and its suppliers to identify the root cause of problem and create remedial plans for short-term and long-term resolutions.
- Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- Support external product development efforts and support other corporation quality initiatives as necessary.
- Strong analysis and problem-solving skills including statistics, capabilities, validations, sampling planning, risk assessment (FMEA) GR&R, is required
- Strong knowledge of metrology tools, inspection techniques, engineering drawings, GD&T,
- Existing knowledge on Internal and external audits and supplier relations and readiness
- Exhibit expertise in Project Management skills for implementation of new product launches
- Computer skills required include Microsoft Access, Excel, Word, Project, Minitab and some graphical based software (i.e. Unigraphics)
- Knowledge of Biologics/Sterility - Biocompatibility, TOC, Bioburden and Cytotoxicity preferred
- Working knowledge of ISO13485, 21 CFR Part 820 Quality Systems.
Education and Experience Requirements:
- Bachelor’s degree in engineering field required OR Equivalent experience
- 5+ years relevant industry experience required
- 3+ years’ experience in project management experience preferred
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