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Staff Engineer, Quality

Job Title: Staff Engineer, Quality
Contract Type: Permanent
Location: Cork
Industry:
REF: 89522
Job Published: 9 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

Staff Engineer, Quality
Our client, a medical device company in Cork are currently looking to recruit a Staff Engineer, Quality for their site.


Job Description / Information
  • The successful candidate will 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, and business meetings etc on a regular basis.
Minimum Qualifications
  • 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.
For further information on this Staff Engineer, Quality role in Cork please contact Bimi Felix on 0868395533 / bimi@hero.ie
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