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