Staff Engineer, Advanced Quality - Innovation Centre in Carrigtohill at Stryker Corporation

Date Posted: 7/3/2018

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Job Description

We are hiring a Staff Engineer, Advanced Quality for our R&D Innovation Centre in Carrigtwohill, Co. Cork. This a permanent position.

Will work within the new product development team, with responsibilities including, but not limited to the following:

  • Help guide NPI teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
  • Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
  • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
  • Support process and product validation programs for new product development
  • Involved in developing, modifying, and executing quality and NPI related company guidelines and procedures.
  • Provide input throughout the new product development process from a quality perspective
  • Perform risk analysis and develop mitigation strategies
  • Collaborate with Design Engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
  • Educate NPI team on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
  • Perform supplier development activities surrounding PPAP
  • Develop and create procedures for incoming, in-process and final inspection
  • May conduct internal Quality system audits and be involved with CAPA projects
  • May have involvement in continuous improvement projects for the organization
  • Mentorship and coaching others
  • Works under general supervision and instruction of more experienced staff.   Reports observations/ problems clearly and concisely and takes appropriate actions.  Demonstrates developing technical leadership skills within department.
  • Possesses and applies a broad knowledge of principles, practices, and procedures of a particular field of specialization to the completion of difficult assignments.


  • Bachelor of Science, Engineering or related subject with 4 years’ experience in a quality or technical discipline
  • 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 an R&D or manufacturing environment required. 2 years’ experience in new product/process is a distinct advantage.
  • CQE or equivalent course work / experience desirable
  • Proficient in understanding of Med Device manufacturing processes desirable.
  • Familiarity with ISO 13485, QSR, GDP, GMP desirable.
  • Lean Six Sigma training a distinct advantage.
  • Working knowledge of Process Validation and Computer System validation
  • Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
  • Ability to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerance.
  • Must be able to generate, follow and explain detailed operating procedures    (i.e. assembly instructions, inspection procedures etc).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
  • Experience in executing complex problem solving techniques related to design/technical issues. Good instincts and sound judgment for mechanical and structural design.
  • Ability to manage several projects through the use of excellent analytical skills in planning, organising, and implementing multiple concurrent tasks.
  • Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams.  Open minded- able to recognize good ideas.
  • Strong team player who effectively utilises individual strengths and talents to maximise team services to customers. Focuses on achievement of team objectives and team success.
  • Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
  • Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
  • Manages change well and adopts a continuous improvement orientation to the role
  • Excellent English (both oral and written)
  • Ability to be the voice of Quality when dealing cross functionally

Work From Home: No

Travel Percentage: Up to 25%

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