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

Date Posted: 11/18/2019

Job Snapshot

Job Description

YOUR RESPONSABILITIES

  • 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.
     

YOUR PROFILE
 

  • 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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