Quality Engineer

Quality Assurance Engineer

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.

Position Requirements:

• 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.

Qualification Knowledge Skills:

• 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