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Engineer, Divisional Quality (EUMDR) in Carrigtohill at Stryker Corporation

Date Posted: 11/26/2018

Job Snapshot

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Job Description

Senior Engineer, Divisional Quality (EUMDR)

Your key responsibilities

Will work within the new product development team, with responsibility for quality related activities, including, but not limited to the following:

  • Investigating customer complaints to determine product failure root causes and evaluate risk of failures.
  • Investigating related failures, design, and manufacturing history of failed devices.
  • Documenting complaint and failure investigation results as appropriate.
  • Updating and maintaining risk management documentation as appropriate.
  • Trending and analyzing post market product failure data.
  • Supporting design controls activities utilizing post market product data.
  • Participating in and leading cross-functional product improvement teams to identify and define product improvement opportunities.
  • Initiating, tracking, and documenting commercial hold issues.
  • Authoring and/or contributing to Technical Assessments and other information to be used in the Product Field Action process.
  • Supporting the International registration process for new and existing products.
  • May support international standards revision projects on behalf of quality, e.g. EU MDR, ISO 60601, etc.
  • May travel as needed to customer accounts to provide product expertise and observe utilization practices.
  • May assist the service repair team with troubleshooting returned devices where applicable.
  • May conduct internal quality system audits and be involved with CAPA projects.
  • May perform the Advanced Quality Engineering responsibilities for the introduction of new products, processes and technologies.   
  • May assist Product Engineering in a quality engineering support role, to include:
    • Helping guide R&D through the quality system to ensure product changes are carried out in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
    • Reviewing and evaluating product change documentation for compliance as well as sound technical competence to ensure delivery of robust products changes.
    • Performing risk analysis and developing mitigation strategies for product changes.
    • Collaborating to develop robust verification test strategies to ensure safe, reliable product changes are implemented
  • 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.

What are we looking for?

  • Bachelor's Degree in Engineering, Science, Quality or equivalent discipline is required.
  • A minimum of 2 years’ experience in a Technical or Quality position within an R&D or manufacturing environment
  • 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: No

    Travel Percentage: None

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