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Vacancy Details

Quality

Staff Engineer, Quality - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 1/10/2017
Job Reference: 89522

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
Check out all our open jobs on our HERO Recruitment website - www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval

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“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

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