This is a fantastic opportunity to play a key role in maintaining and enhancing quality systems within a regulated environment. You'll be at the forefront of ensuring compliance, driving continuous improvement, and supporting product development in a dynamic and collaborative setting.
This is a full time, permanent, onsite role. Monday to Friday on Days.
Your Key Responsibilities
* Maintain and improve quality systems aligned with ISO 13485, ISO 9001, and applicable medical device regulations.
* Develop and revise SOPs and quality documentation.
* Conduct internal audits to ISO 13485 standards.
* Actively participate in customer and regulatory audits.
* Support new product development, including trials, sampling, and production runs.
* Monitor vendor performance, issue non-conformance reports (NCMRs), and implement controls to protect product integrity.
* Report on quality performance metrics and lead change control initiatives.
* Investigate and close validation deviations, non-conformances, and CAPAs.
* Assist in the creation and execution of validation protocols (IQ/OQ/PQ), including data analysis and test scripting.
Who You'll Work With
* Collaborate closely with the Quality Team to share knowledge and uphold standards.
* Liaise with production teams to resolve quality issues and ensure smooth operations.
Decision-Making Scope
* Make informed decisions on product quality issues flagged during production.
* Escalate complex problems to senior quality leadership when necessary.
What You Bring
* Bachelor's degree in Science, Engineering, or a related field.
* Minimum of 3 years' experience as a Quality Engineer in an ISO 13485 regulated environment.
* Certified Internal Auditor to ISO 13485.
* Proven experience in equipment validation and statistical analysis.
* Strong interpersonal skills, attention to detail, and a proactive problem-solving mindset.
Why You'll Love This Role
* Be part of a team that values precision, collaboration, and continuous improvement.
* Gain exposure to a wide range of quality assurance activities in a regulated industry.
* Develop your career in a supportive environment with opportunities for growth and learning.
Click below to apply.