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130 Quality Procedures Jobs - Page 6

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10 - 15 years

12 - 15 Lacs

Ahmedabad

Work from Office

Oversee implementation of quality assurance (QA) and quality control (QC) testing activities in the Plant Lead cost optimization plans and drive integrated initiatives with BU Heads Required Candidate profile Comprehensive knowledge of quality systems and standards (ISO 9001, 14001, IATF etc) Experience of dealing with leadership and senior stakeholders

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6 - 10 years

6 - 9 Lacs

Oragadam

Work from Office

Position Summary: We are seeking an experienced and proactive Quality Control Manager with a strong background in In Vitro Diagnostics (IVD) to lead and oversee all QC activities within our manufacturing and development operations. The QC Manager will be responsible for ensuring that IVD products meet internal quality standards and comply with international regulatory requirements. This role plays a key part in managing a QC team, improving processes, and supporting product development and commercial release. Role & responsibilities Lead and manage the Quality Control team, ensuring daily testing activities are conducted efficiently and in compliance with regulatory requirements (ISO 13485, FDA 21 CFR Part 820, and CE-IVD). Develop, implement, and maintain QC procedures for raw materials, in-process controls, and final product testing for IVD devices, including immunoassays, molecular diagnostics, and rapid tests. Oversee method validation, equipment qualification (IQ/OQ/PQ), and routine calibration and maintenance of laboratory instruments. Review and approve QC test results, reports, and batch records, ensuring timely product release. Manage investigations of non-conformances, deviations, out-of-specification (OOS) results, and implement corrective and preventive actions (CAPAs). Participate in cross-functional teams for new product development, transfer-to-manufacturing activities, and continuous improvement initiatives. Ensure compliance with GLP/GMP requirements and prepare for internal and external audits (e.g., ISO, FDA, notified bodies). Provide leadership, training, and mentorship to QC staff, fostering a culture of quality and accountability. Monitor QC metrics and KPIs, and report regularly to senior management. Maintain and improve the Quality Control Laboratory environment, including documentation, data integrity, and safety practices. Education: Bachelors or Masters degree in Biotechnology, Biochemistry, Microbiology, Life Sciences, or a related field. Experience: Minimum 610 years of experience in Quality Control, with at least 3 years in a managerial or supervisory role within the IVD or medical device industry. Skills: In-depth knowledge of IVD regulations and quality standards (ISO 13485, FDA QSR, CE-IVD). Strong leadership, team-building, and project management skills. Proven experience in implementing and improving QC systems and processes. Excellent problem-solving skills and experience with RCA and CAPA tools. Proficiency in LIMS, statistical analysis, and data management tools. Preferred candidate profile Experience with regulatory submissions, audits, and inspections (FDA, ISO, EU MDR). Familiarity with risk management (ISO 14971), design controls, and product lifecycle management. Quality certifications (e.g., ASQ CQM/OE, Six Sigma Green/Black Belt) are a plus

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3 - 8 years

3 - 6 Lacs

Mumbai, Navi Mumbai

Work from Office

Analyze Quality & food safety related data in order to find areas for continual improvement Draft/review/modify quality assurance policies and procedures in order to ensure that they align with food safety & quality standards. Required Candidate profile Design, implement and improve company quality standards. Responsible for ISO 9001 & FSSC 22000 documentation , internal/external audit Vendor visit/ Audit

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1 - 3 years

2 - 3 Lacs

Pimpri-Chinchwad

Work from Office

Responsibilities: * Develop quality procedures & documentation * Conduct internal audits as QA specialist * Ensure compliance with industry standards * Lead quality initiatives & improvements * Implement quality management systems Provident fund Annual bonus Employee state insurance

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2 - 4 years

2 - 3 Lacs

Mumbai, Vasai, Palghar

Work from Office

Conduct quality inspections on raw materials, in-process production, and finished products. Develop and implement quality control processes to improve product reliability and performance. Ensure compliance with industry standards Required Candidate profile Diploma / Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a related field. Strong understanding of quality standards such as ISO, ASTM, or other relevant regulations. Perks and benefits Pick & Drop Facility from Nallasopara

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