Staff Quality Engineer-2 in Carrigtohill at Stryker Corporation

Date Posted: 8/2/2020

Job Snapshot

Job Description



Staff Engineer, Quality

Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent.   The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 4 or more years experience.

Provide quality leadership and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.

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.
  • 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: Regularly scheduled days

Travel Percentage: 50%

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