
Medical Device Quality Assurance Professional
1 day ago
This role focuses on ensuring the highest standards of quality and compliance in product development, manufacturing, and post-market activities.
- Quality Management System (QMS): Develop and maintain a QMS that aligns with regulatory requirements, ensuring products meet quality, safety, and performance standards.
- Regulatory Expertise: Stay up-to-date with global medical device regulations and standards, providing expertise to support market entry and ongoing compliance.
- Documentation Control: Establish and maintain accurate documentation, including technical files, regulatory submissions, quality agreements, and internal procedures.
- Design Control & Development Support: Collaborate with cross-functional teams to ensure QA/RA input is integrated into design and development activities, ensuring compliance from the outset.
- Risk Management: Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Post-Market Surveillance & Vigilance: Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
- Supplier Quality Management: Support the management of supplier quality and compliance.
- Internal Audits & Process Improvement: Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
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Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Medical Device Quality Assurance LeadWe are seeking an accomplished professional to lead quality assurance efforts for medical devices. The ideal candidate will possess a deep understanding of regulatory frameworks and quality systems.Key Responsibilities:Regulatory Compliance: Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS...
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Senior Medical Device Specialist
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Senior Regulatory Affairs Professional
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Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Job Title: Regulatory Compliance Expert">Location: Remote Position Overview: An experienced professional with expertise in both pharmaceutical and medical device regulatory compliance is sought after to prepare, review, and submit regulatory documentation to global health authorities. The ideal candidate will have a strong background in regulatory...
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Quality Assurance Professional
1 day ago
Kurnool, Andhra Pradesh, India beBeeQuality Full time ₹ 10,00,000 - ₹ 15,00,000Job Overview:Our organization seeks a meticulous Quality Assurance Professional to play a pivotal role in maintaining the highest standards of quality.This position involves overseeing and executing inspections, testing, and audits to ensure seamless integration with our business objectives.The ideal candidate should have an analytical mindset, with...