(Staff) NPI Quality Engineer

POSITION SUMMARY

Supports and executes design for manufacture and assembly through technical leadership in quality assurance, design 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. Support the development and characterization of processes that are capable, scalable and produce high yield. Will support the design of robust inspection strategies including CQA’s, CTQ’s and MSA’s to enable process risk identification, process characterization, capability and robust process control. Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development. Provide Quality engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.

POSITION REQUIREMENTS

Will reside within the NPI QE team as part of GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following:

General

• Foster and lead collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities. Drive and lead effective communication with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
• Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
• Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.

Risk Management

• Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).
• Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release) through robust pFMEA.
• Ensure all Risk Management outputs comply with ISO14971.
• Support Design team to complete CQA/CTQ identification and inputs to dFMEA.

Inspection

• Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable.
• Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination.
• Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.
• Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.

Validation

• Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.
• Influence processes towards validation versus manual verification, where possible.
• Support Sterilisation validation activity, as required.
• Process Excellence
• Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
• Provide expertise for NC’s & CAPA’s related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.
• Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.
• Support ‘process bench marking’ by providing quality experience as a process input.
• Will promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.

Purchasing Controls

• Support the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable, and meet Stryker expectations.
• Provide Quality input to influence the proper selection of suppliers.
• Support implementation of supplier certification.
• Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.

Design Transfer

• Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets including Right First Time (RFT), manufacturing loss, inspection costs per unit and product escapes, in conjunction with other targets per the DTAP.
• Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.
• Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.
• Support device design into production specifications.
• Lead the efficient and timely transfer of lessons learnt knowledge to Quality engineering support, and regional peers.
• Provide expert quality process support post launch per DTAP agreement.
• Support the control of product, through appropriate system containment to guard against product escape during pre-released builds.

QUALIFICATION KNOWLEDGE SKILLS

• Bachelor of Science, Engineering or related subject with 4 years’ experience in a quality or technical discipline or
• Master of Science, Engineering or related subject with 2 years of experience in a quality or technical discipline or
• Note: Local qualifications may differ and will take precedence over the above criteria

• Previous experience in a regulated environment within a manufacturing environment required. 2 years’ experience in new product/process is a distinct advantage.
• CQE or equivalent course work / experience desirable
• Familiarity with advanced product quality planning framework and techniques used to develop products, a distinct advantage.
• Proficient in understanding of Med Device manufacturing processes desirable.
• Familiarity with ISO 13485, QSR, GDP, GMP desirable.
• Lean Six Sigma training a distinct advantage.
• Highly proficient in all aspects of Validation. Computer System validation a distinct advantage.
• Analytical & problem-solving skills, process improvement orientation, and the ability to handle multiple tasks.
• Competency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance.
• Must be able to generate, follow and explain detailed operating procedures
• Experience in executing complex problem-solving and process improvements techniques related to design/process/technical issues using lean six sigma tools like DMAIC.
• Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
• Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.
• Working knowledge/experience of risk based and statistical techniques, in particular process risk, failure mode and effect analysis (FMEA), statistical sampling plans, process capability and MSA’s.
• Manages change well and adopts a continuous improvement mindset
• Excellent English (both oral and written)
• Ability to be the voice of quality when dealing cross functionally