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Staff Quality Engineer,Technology Development in Carrigtohill at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

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Job Description

Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

  • Initiate and build productive and collaborative internal/external professional relationships across Design Divisions & GQO functions associated with technology development activities. Encourage, inspire, and influence others, creating a positive impact on the team.
  • Communicate effectively with all Customers, Stakeholders and project teams in delivering on quality and project goals.
  • As a key member of the Technology Development team, be accountable for implementing quality systems while meeting internal customer expectations, quality objectives, project planning and effective execution, as well as escalating issues when appropriate.
  • Ensure Tech Dev teams are aware of quality requirements in place to help with patient safety and compliance to international regulatory requirements. Ensure all projects are in compliance with GMP, QSR, ISO or other applicable requirements.
  • Coordinating efforts for the development and implementation of new and updated Quality System procedures required throughout the technology development lifecycle. Strong team member with the ability to identify and implement opportunities for continuous improvement in the quality system.
  • Experienced in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
  • Develop & Implement Risk Management Principles. Lead and ensure Risk Management documents are generated and applied during process development to minimize risk to patient or user harm. Ensure all Risk Management outputs comply with ISO 14971 for use in Regulatory Submissions.
  • Provides innovative quality and technical input during the Technology Development Lifecycle.
  • Support Process Development and Characterization to establish Process windows, Process Control, Process Monitoring and Trace Matrix deliverables as required. Supports teams with the development of Engineering Studies, leveraging practices and technical writing skills
  • Supports the development and implementation of technology and process improvements, inspection strategies and plans for associated projects. Takes initiative in and makes continuous strides towards optimization of inspection methods and sampling.
  • Has the authority to order the cessation of all activities in relation to technology development. In addition, has the authority to order recommencement of these activities provided he/she is satisfied that all issues affecting product safety and efficacy have been addressed.
  • In partnership with Supplier Quality, source and onboard new vendors.
  • Contribute to the creation of Material Specifications, as required, and work closely with the development teams on methods of Material Specifications characterization.
  • High proficiency in statistical methods and application to support data-driven decision making. Work closely with project teams to develop DOEs and statistically sound test criteria. Develop statistically based sampling plans for studies as deemed necessary.
  • Provide audit support (internal & external) associated with Technology Development procedures, processes and Quality records.
  • Responsible for and ensures the efficient and timely transfer of knowledge to Quality engineering support within NPI/Production environments.
  • Oversight and activist of NC & CAPA related as an expert and mentor in problem solving and root causing activities.
  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
  • Support due diligence and associated activities during mergers and acquisitions.
  • Mentor to support groups and other functions on areas of expertise pertaining to technology and process development, risk, statistics, validations (test method, process and equipment) and problem solving.

Work From Home: No

Travel Percentage: None

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