Job Description:
We are seeking a driven QA Validation Specialist to play a key role in ensuring site-wide validation and regulatory compliance.
As a QA Validation Specialist, you will coordinate and maintain the site validation program, ensuring compliance with FDA, European cGMP, and GAMP standards.
This is a hands-on role involving planning and executing validation activities, managing quality processes, and driving continuous improvement initiatives across equipment, utilities, processes, and software systems.
* Develop, execute, and maintain validation master plans and project validation plans.
* Prepare and execute validation protocols, reports, and investigations in line with cGMP standards.
* Lead validation and quality assurance for site equipment, processes, and software.
* Support regulatory compliance through robust documentation, audits, and process improvements.
* Manage change control, exception events, and corrective actions.
* Provide cross-training, mentorship, and support to team members.
* Actively contribute to continuous improvement in manufacturing, quality, and safety systems.
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Required Skills & Qualifications:
* Degree in an engineering or scientific discipline.
* 3+ years' experience in validation/quality within medical device plastics processing, molding, or assembly operations.
* Strong knowledge of cGMP and medical device regulatory requirements.
* Excellent communication, organizational, and troubleshooting skills.
* Ability to work independently and collaboratively, with strong prioritization and multitasking skills.
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About the Role:
This role offers the opportunity to drive quality and excellence in our manufacturing processes.
The successful candidate will be able to effectively collaborate with the team and demonstrate a commitment to delivering high-quality results.
Key responsibilities include:
* Development and implementation of validation strategies
* Leading quality assurance efforts
* Providing training and guidance to team members
Contact Information:
To apply for this position, please submit your application. We look forward to hearing from you.