Position Summary

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

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.

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

Travel Percentage: 10%

Quality Engineer

Job Description