We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

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

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.