This position offers the chance to play a key role in ensuring world-class quality standards within a highly regulated environment. You'll gain hands-on experience with cutting-edge validation processes and contribute to the development of innovative products.
What You'll Do
* Lead and execute validation protocols and reports for new product introductions and revalidations (IQ, OQ, PQ) in compliance with international standards.
* Analyze validation data to make informed recommendations that directly impact product quality and performance.
* Qualify new and existing manufacturing equipment, ensuring optimal installation and functionality.
* Maintain audit readiness and traceability for all validation activities, giving you exposure to regulatory compliance.
* Mentor colleagues and share expertise, strengthening your leadership and technical influence.
* Support quality system maintenance aligned with ISO 13485, ISO 9001, and medical device regulations.
* Participate in product development activities, including trials and production runs, expanding your technical breadth.
* Drive continuous improvement initiatives through data-driven decision-making and change control processes.
* Manage investigations and closure of validation deviations, non-conformances, and CAPAs, enhancing your problem-solving skills.
What's In It For You
* Opportunity to work on diverse projects in a regulated industry, building expertise in validation and quality assurance.
* Develop leadership skills through mentoring and cross-functional collaboration.
* Gain experience with international standards and regulatory audits, boosting your professional profile.
* Be part of innovation in product development and manufacturing processes.
What You Bring
* A degree in Science, Engineering, or a related field.
* At least 2 years' experience in validation engineering within injection moulding, blow moulding, or medical device manufacturing.
* Strong skills in statistical analysis (e.g., Minitab), SPC, and validation methodologies.
* Excellent problem-solving abilities, attention to detail, and interpersonal skills.
* Ability to work independently and as part of a team.
* Familiarity with ISO 13485 requirements is a plus.
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