Senior Quality Engineer, NPI

This is a 12 Month Fixed Term Contract

Senior Quality Engineer NPI

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.

What You'll Do:
• 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.
• 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
• 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. 
• 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 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.

What You'll Need:

• 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