In this role you will represent the Quality Function on Project Team for both new product development and existing products. You will be supporting Quality Design Assurance for the specific product platforms. The Senior QE is involved in new product development and product maintenance through the application of Quality engineering skills. Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.
The successful applicant will play an active role in the procedures to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements.
- Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, supplier quality assurance etc.) as needed for the project.
- Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adeptly apply working knowledge of quality engineering concepts within the product life-cycle.
- Write project quality plan
- Lead risk management activities within the project.
- Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.
- Assist / conduct Failure investigations and problem-solving sessions
- Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports.
- Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
- Ensure process validation activities are completed appropriately and make the link with product design whenever needed.
- Conduct quality functional reviews and DHF compliance reviews.
- Ensure compliance across projects for design control, risk management and change control processes. Support Quality culture within R&D organisation while providing training on applicable requirements / standards.
- Bachelor’s Degree in Engineering required, electrical or mechanical preferred
- Minimum 5-7 years of medical device quality engineering experience
- Experience working in the medical device sector
- Expertise in design assurance including design controls and risk management (ISO 13485)
- Experience reviewing and approving test protocols
- Embedded software validation experience
- Experience working with Design History Files (ISO 13485)
- Experience with Software Quality (ISO 62304)
- Capital Equipment validation
- General understanding of Statistical methods for quality assurance
- Ability to act as Change Agent and effectively manage change
- Experience working with cross-functional teams and remote teams, promote work in multidisciplinary teams
- Demonstrate strong and clear accountability for successful and timely completion of tasks
- Influence: Intuitively and quickly assess people and situations and act accordingly. Demonstrate persuasion and timing skills. Remain open to be persuaded when appropriate.
- Prefer infusion pump experience or drug delivery experience (regulated FDA industry)
- Capital equipment validation and reliability testing is an advantage
If you’re a team player who is passionate about Engineering and advancing the world of health then please click on the APPLY button or alternatively send your CV directly to –