Staff Quality Engineer
Our client, a medical device company in Cork is currently looking to recruit a Staff Quality Engineer for their site.
- 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.
The Ideal Candidate:
- Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, or
- Masters of Science, Engineering or related subject with 0 years of experience
- Previous experience in a regulated environment desirable.
- CQE or equivalent course work / experience desirable
- Proficient in understanding of Med Device manufacturing processes desirable.
- Familiarity with ISO 13485, GDP, GMP desirable.
- Lean Six Sigma training a distinct advantage.
- Excellent communication skills and attention to detail.
- Have a good understanding of engineering and quality practices & methods.
For further information on this Staff Quality Engineer role please contact Orla on 0860449473 / firstname.lastname@example.org
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