Design Quality Engineer for innovative medicine products for Trauma & Extremities in Carrigtohill at Stryker Corporation

Date Posted: 2/18/2020

Job Snapshot

Job Description

Review and guide the different Project teams in the development projects.

Is responsible that the developed products are compliance and fullfill internal and external requirements and fulfill the requirements of interntional standards.

Is familiar with MDD,MDR, QSR CFR21 Part 820

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.


  • Develop quality assurance documentation to support the new product development processes and regulatory submissions.
  • Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
  • Engage in the design, development, manufacturing, and risk management activities for new product development projects.
  • Engage in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
  • Complete final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
  • Promote efficient testing practices.
  • Support Advanced Operations in the development of manufacturing processes for new products.
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
  • Develop, review, and approve inspection plans, routers, and product drawings for new products.
  • Support product design transfers to internal and/or external manufacturing facilities.
  • Evaluate predicate products for relevant quality issues that may impact new product development projects.
  • Analyze and define critical quality attributes for product and process through risk analysis techniques.
  • Participate in the collection of initial market feedback on new products and address early concerns.
  • Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.


  • You are an engineer in the field of mechanical engineering, mechatronics, medical technology, chemistry, biotechnology or have a degree in an equivalent subject of study.
  • You know the medical devices norm ISO 13485 very well and have at least 4 years of experience in quality management, ideally in the medical device industry.
  • Moreover, you are familiar with MDR and have knowledge of measurement technology and manufacturing engineering.
  • You have very good English skills, have had experience in Design and or quality process and are familiar with the typical MS Office applications.
  • Your team orientation, strong communication skills, and your assertiveness along with a high-quality awareness and an independent work style complete your profile.

Work From Home: Not available

Travel Percentage: 10%

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