Job Details: Senior Quality Engineer, Product Introduction


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Quality Engineer, Product Introduction
Position: ?Senior Quality Engineer, New Product Introduction
About Stryker

Stryker is one of the world?s leading medical technology companies
and, together with our customers, is driven to make healthcare better.


_WE OFFER_ innovative products and services in Orthopaedics, Medical
and Surgical, and Neurotechnology and Spine that help improve patient
and hospital outcomes. We are proud to be named one of the World?s
Best Workplaces and a Best Workplace for Diversity by Fortune
Magazine. Learn more about our award-winning organization by visiting
stryker.comWill reside within the regional 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 ISO
**Apply on the website**.

Support Design team to complete CQA/CTQ identification and inputs to
dFMEA to enable process risk identification, process characterization,
process capability and robust process control.

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

Lead 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.

Bachelor of Science, Engineering or related subject with 4 years?
experience in a quality or technical discipline or 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.

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 **Apply on the website**, 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.

_ABILITY TO_ manage several projects ellent 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

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for
this position. Learn more about our employee referral program. Position: ?Senior Quality Engineer, New Product Introduction
About Stryker

Stryker is one of the world?s leading medical technology companies
and, together with our customers, is driven to make healthcare better.


_WE OFFER_ innovative products and services in Orthopaedics, Medical
and Surgical, and Neurotechnology and Spine that help improve patient
and hospital outcomes. We are proud to be named one of the World?s
Best Workplaces and a Best Workplace for Diversity by Fortune
Magazine. Learn more about our award-winning organization by visiting
stryker.comWill reside within the regional 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 ISO
**Apply on the website**.

Support Design team to complete CQA/CTQ identification and inputs to
dFMEA to enable process risk identification, process characterization,
process capability and robust process control.

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

Lead 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.

Bachelor of Science, Engineering or related subject with 4 years?
experience in a quality or technical discipline or 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.

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 **Apply on the website**, 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.

_ABILITY TO_ manage several projects ellent 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

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for
this position. Learn more about our employee referral program.

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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