Job Title
A permanent contract role based on our Anngrove site.
Key Responsibilities:
* Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control, and preventative activities.
* Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
* Develops and characterizes processes that are capable, scalable, and produce high yield.
* Supports the design of robust inspection strategies including CQA's, CTQ's, and MSA's.
* Provides quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.
Collaboration and Communication:
* Resides within the regional NPI QE team as part of GQO Quality Assurance organization.
* Works collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities.
* Communicates effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality.
Risk Management:
* Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production-related processes (PFMEA).
* Supports the Risk Management File through risk management principles.
* Evaluates process risks, risk mitigation, and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle.
Inspection:
* Develops and implements lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies.
* Ensures inspections are repeatable, efficient, and scalable.
* Leads continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.
Validation:
* Supports the development, execution, and approval of validation strategies, with the goal of highly capable processes that result in high yield and enable scalability.
* Approves protocols and reports, including data analysis.
* Influences processes towards validation versus manual verification, where possible.
Process Excellence:
* Applies appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
* Provides expertise for NC's & CAPA's related to new products.
* Acts as a subject matter expert and mentor in problem-solving and root-cause analysis tools.
Purchasing Controls:
* Leads the supplier qualification strategy and approves the supplier validations and Production Part Approval Process (PPAP).
* Ensures Suppliers' Quality Systems can complete process characterization and develop highly capable processes that are scalable and meet Stryker expectations.
* Provides Quality input to influence the proper selection of suppliers.
Design Transfer:
* Represents quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets.
* Provides subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.
* Represents NPI Quality Assurance at Design reviews and ensures integrity of the process design through robust NPI quality deliverables.
Requirements:
* Bachelor of Science, Engineering, or related subject with 4 years' experience in a quality or technical discipline.
* Masters of Science, Engineering, or related subject with 2 years of experience in a quality or technical discipline.
* Previous experience in a regulated environment within a manufacturing environment required.
* 2 years' experience in new product/process is a distinct advantage.