Staff NPI Quality Engineer

Stryker Corporation; Municipal District of Cobh; Hybrid; EUR 54,000 - 90,000; Full time

Job summary

Stryker Corporation is seeking a Quality Assurance engineer to lead design transfer, risk assessment, and process validation for new products. You will shape inspection strategies, support NPI programs, and ensure regulatory compliance across the product lifecycle.

Ideal candidates have 4+ years in quality within manufacturing, strong English communication, and a continuous improvement mindset. Hybrid work and travel up to 20% are expected.

Qualifications

• Bachelor of Science in engineering or related discipline with 4 years’ experience in quality or technical discipline.
• Experience in a regulated manufacturing environment is required.
• Lean Six Sigma training is a plus; strong problem solving and data analysis skills.

Responsibilities

• Lead design transfer activities and communicate with cross-functional teams to ensure quality targets.
• Develop and validate inspection strategies, including CQA/CTQ and pFMEA.
• Support risk management, validation strategies and ISO14971 compliance.
• Mentor teams in problem solving, root cause analysis and statistical techniques.

Skills

Quality engineering

Design transfer

Risk management

NPI

FMEA

Analytical problem solving

Education

Bachelor of Science, Engineering or related subject

Tools

Validation protocols

Job description

Summary

Work Flexibility: Hybrid 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

• 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.

Qualification Knowledge Skills

• Bachelor of Science, Engineering or related subject with 4 years’ 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 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 #IJ

Pay Ranges

Pay Ranges: Ireland: €54,000 - €90,000 EUR Annual At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package. If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.

Travel and Work Flexibility

Travel Percentage: 20% Stryker is one of the world’s leading medical technology companies and, together with its 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! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.