23 Month Fixed Term Contract
Job Title
Sr. NPI Quality Engineer
Reports To
NPI QA Leader
Position Summary
Executes design for manufacture and assembly through technical understanding of quality assurance, design control and preventative activities. Supports the development and introduction of new products, processes, and technologies, with focus on executing project deliverables with the guidance of senior engineering staff. 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 collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.
- 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 protocols and reports.
- 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.
- 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).
- Support 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, under the guidance of Senior NPI QE engineers.
- 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 global 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
- B.S in Engineering or related subject with 2 or more years’ experience
or
- Previous experience in a regulated environment within a manufacturing environment desirable. 2 years’ experience in new product/process is a distinct advantage.
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.
- Excellent analytical skills, ability to plan, organize and implement concurrent 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
- Understanding of complex problem-solving and process improvement techniques related to design/process/technical issues using lean six sigma tools like DMAIC.
- Ability to manage several projects at once.
- Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.
- Basic 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