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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