Purpose of Job
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.
Key Responsibilities
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.
- 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.
Who we are looking for
- Bachelor of Science, Engineering or related subject and 4 years of work experience in a quality discipline.
- Proficient in understanding of Med Device manufacturing processes preferred.
- Proficient in ISO 13485, GDP, GMP.
- 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.
- Excellent English and Polish (both oral and written)
- Experience in project transfer and validation processes
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