Staff Engineer, Advanced Quality in Carrigtohill at Stryker Corporation

Date Posted: 11/18/2018

Job Snapshot

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Job Description

Provide leadership 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. Mentor and provide technical direction across multiple areas of expertise.

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.

Position requirements:  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.

Qualification, Knowledge, Skills:

  • Bachelor's Degree in Engineering, Science, Quality or equivalent discipline is required.
  • A minimum of 4 years experience in a Techinical or Quality position within an R&D or manufacturing environment
  • Alternatively, a Master’s Degree in Engineering, Science, Quality or equivalent discipline.
  • Previous experience in a regulated environment required
  • CRE or equivalent course work / experience desirable
  • Proficient understanding of Med Device manufacturing processes, FDA QSR, ISO 13485, GMP.
  • Lean Six Sigma/4D training and experience required
  • Excellent communication skills and attention to detail
  • Has indepth knowledge of engineering and quality practices & methods
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, PowerPoint and One Note.
  • Exhibits strong leadership and mentoring behaviours
  • 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.
  • High level 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. Has expertise that is leveraged by the organisation.
  • 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.
  • Presents as a change agent and adopts a continuous improvement orientation to the role
  • Ability to be the voice of Quality when dealing cross functionally.  Proven ability to influence multiple stakeholders and ensure the correct outcome.
  • Excellent English (both oral and written)

Work From Home: No

Travel Percentage: Up to 25%

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