Advanced Quality engineer, R&D in Carrigtohill at Stryker Corporation

Date Posted: 2/18/2020

Job Snapshot

Job Description

"At Stryker, we are driven to make healthcare better through our core values of integrity, accountability, people and performance. We are committed to designing, developing and delivering a premium product for our customers. The Senior Advanced Quality Engineer helps Stryker achieve this goal by integrating quality into the design and process during New Product Development (NPD). Provide support and direction for the implementation of quality systems associated with New Product Introduction (NPI) projects for the Research, Development and Introduction of new Products, Processes and Technologies.   Has responsibility for quality engineering oversight, quality systems implementation including test and inspection plans and product reliability during product development, verification, validation and design transfer whilst ensuring compliance to FDA Quality System Regulations and ISO 13485.  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
  • Involvement in training others
  • Leader of self
  • Conducts standard as well as non-standard  tasks under close supervision and guidance of more experienced staff.  Keeps supervisor informed regularly on status of work.
  • Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization.
  • Bachelor's Degree in Engineering, Science, Quality or equivalent discipline is required.
  • A minimum of 2-3 years experience in a Technical or Quality position within an R&D or manufacturing environment
  • A minimum of three years’ experience as an AQE is a distinct advantage
  • Previous experience in a regulated environment required
  • CQE or equivalent course work / experience desirable
  • Proficient understanding of Med Device manufacturing processes required
  • Familiarity with ISO 13485, GDP, GMP required.
  • Lean Six Sigma training a distinct advantage
  • Excellent communication skills and attention to detail
  • Has a strong understanding of engineering and quality practices & methods
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, PowerPoint and One Note.
  • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
  • Must be willing to work as part of a multi-site team, with travel required.
  • Working knowledge/experience of risk based and statistical techniques, in particular process risk, statistical sampling plans, process capability, Gauge R&Rs.
  • Highly developed problem solving and strong analytical skills
  • Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
  • Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.
  • Manages change well and adopts a continuous improvement orientation to the role
  • Ability to be the voice of Quality when dealing cross functionally. Will take the lead in discussions / meetings to ensure the correct outcome.
  • Excellent English (both oral and written)

Work From Home: Not available

Travel Percentage: 10%

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