About this role
Work Flexibility: Onsite
Provide quality engineering support 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.
• 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.
• France • Engineering/Science licence and 2 years work experience in a quality discipline or • Engineering diploma (diplôme d'ingénieur)
• Germany / Switzerland • Masters or Bachelor of Science, Engineering or related subject • Technician degree (or similar Level 6 Education like Meister)
• Ireland / North America • Masters or Bachelor of Science, Engineering or related subject
• Previous experience in industry desirable • Understanding of Med Device concepts desirable. • Familiarity with ISO 13485, GDP, GMP concept desirable. • Excellent communication skills and attention to detail. • Have a good understanding of engineering and quality concepts / theories. • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages. • Self-starter with efficient work style 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. • Knowledge of Risk Based and statistical concepts desirable. • Problem solving and 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. • Accepts change openly 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
Travel Percentage: 0%