Staff Quality Engineer in Carrigtohill at Stryker Corporation

Date Posted: 7/31/2018

Job Snapshot

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Job Description

Your Key responsibilities:

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

  • Work closely with operations and the business functions to ensure quality performance of product and processes.

  • Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.

  • Initiates and lead in the development and improvement of the manufacturing processes for existing and new products.

  • Oversight and leads investigations during concession management.

  • Review and approval of change management activities, challenges change effectiveness and drives strong review.

  • Interpret KPI trends, take action as necessary, driving a continuous improvement process.

  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.

  • Subject matter expert in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.

  • Proficiency in and provides technical direction in optimization of inspection methods and sampling.

  • High proficiency in statistical methods and application.

  • Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manages audit logistics and preparation.

  • Aids in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.

  • Support manufacturing transfers to other plants/facilities, leading quality activities.

  • Responsible for initiation, management and support of ship, product Holds, potential product escapes.

  • Coach and mentor the quality team and others business function in quality topics and activities, with several topics at expert level.

  • Deputises proficiently for management in temporary absence, periodic review boards, business meetings etc on a regular basis.

What are we looking for:

  • Ireland

    • Bachelor degree in Science, Engineering or equivalent/ related subject and 4 years of work experience in a quality discipline, or

    • Masters of Science, Engineering or related subject with 2 years of experience

  • Previous experience in a regulated environment required.

  • CQE or equivalent course work / experience desirable

  • Proficient in understanding of Med Device manufacturing processes required.

  • Proficient in ISO 13485, GDP, GMP.

  • Lean Six Sigma training a distinct advantage.

  • Excellent communication skills and attention to detail.

  • Have a good understanding of engineering and quality practices & methods.

  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

  • 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 some 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.

  • 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 keys to help achieve outcomes.

  • Presents as a change agent 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, will take the lead discussions / meetings to ensure the correct outcome.


        Work From Home: No

        Travel Percentage: None

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