Responsibilities:
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* Validate and quality assure site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
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* Develop and maintain the Site Validation Master Plan.
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* Design and execute Project Validation Plans and schedules.
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* Create validation protocols and final reports to cGMP standards.
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Requirements:
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* Hold a qualification and/or degree in engineering or a scientific discipline.
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* Have 3+ years of validation/Quality experience in medical device plastics processing, moulding, or assembly operations.
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* Possess 3+ years of knowledge of cGMP and regulatory requirements relating to the medical device industry.
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Skillset Overview:
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1. Strong analytical skills with attention to detail.
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2. Able to work independently and collaboratively as part of a team.
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3. Excellent communication and interpersonal skills.
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About This Role:
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This QAV Engineer will be responsible for ensuring that all site equipment, utilities, processes, and software meet high standards of quality and regulatory compliance. The ideal candidate will have strong analytical skills, excellent communication abilities, and the ability to work effectively both independently and as part of a team.
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In this role, you will have the opportunity to apply your technical expertise and problem-solving skills to drive process improvements and ensure compliance with industry regulations. If you are a detail-oriented individual with a passion for quality assurance and a desire to make a meaningful contribution to a dynamic team, we encourage you to apply for this exciting opportunity.