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 and 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 and; methods.
- Must be proficient with Microsoft Word, Microsoft
- 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.
- 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
- 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. t
Work From Home: Not availableTravel Percentage: None
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