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.
- 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.
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