- Provide quality engineering support 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. 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.
- Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
- Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
- Analysis and review of concession requests.
- Review and approval of change management activities.
- Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
- Support execution and analysis of QATs.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- Proficient 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 makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
- Proficiency in statistical methods and application.
- Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
- Assist in the development, responsible for review & approval of process and equipment validation/qualification.
- 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 others in quality topics and activities.
- 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 Medical 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.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- 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.
- Working 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.
- Manages change well 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
For a confidential discussion and more information on the role, please contact Eloisa Ruiz on 021 49809118 or email email@example.com
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