- Reference: CJ45987
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
- Will work within the quality operations team, with moderate supervision and mentoring, 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.
- Approval of NC, builds proficient in problem solving and root causing activities.
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- Review of change management activities.
- Maintain KPIs 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, familiarity in the science of Human Factor identification, reduction and mitigation.
- Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
- Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
- Developing proficiency in statistical methods and application.
- Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
- Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
- Support manufacturing transfers to other plants/facilities, execution quality activities.
- Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.
- 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.
- 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 Eloísa Ruiz on 021 4911066 or email firstname.lastname@example.org
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