Senior Quality Assurance Specialist
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We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the highest standards of quality and compliance across all aspects of our operations.
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About the Role:
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This is an exciting opportunity for a seasoned quality professional to drive quality assurance activities that support product development, manufacturing, and regulatory compliance. You will work closely with cross-functional teams including R&D, operations, and suppliers to maintain and improve quality systems and processes in line with ISO and FDA regulations.
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Key Responsibilities:
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* Develop and implement quality management systems, ensuring compliance with regulatory standards and industry best practices.
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* Lead audits, investigations, and root cause analyses to identify areas for improvement and implement corrective actions.
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* Collaborate with manufacturing and operations teams to ensure adherence to quality procedures and protocols.
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* Provide quality input and support to internal projects and product lifecycle activities.
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* Liaise with external auditors and regulatory bodies during inspections and audits.
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Requirements:
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To be successful in this role, you will need:
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* A Bachelor's degree in a scientific or engineering discipline.
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* 5+ years of quality engineering experience in the medical device or pharmaceutical industry.
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* Solid understanding of ISO and FDA QSR (21 CFR ) requirements.
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* Strong problem-solving skills with experience in CAPA, NCR, risk management, and root cause analysis.
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* Excellent written and verbal communication skills, able to collaborate effectively with cross-functional teams.
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* Demonstrated ability to work independently in a fast-paced, evolving environment.
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What We Offer:
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We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development.
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Contact Us:
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To learn more about this exciting opportunity, please contact us at your earliest convenience.
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