Quality Control Manager

Sehat Medical Devices Pvt. Ltd. is a rapidly growing company specializing in the manufacturing of cutting-edge medical devices. Our commitment to innovation and stringent quality standards ensures we deliver reliable products that enhance patient outcomes.

Position Overview

We are seeking a Quality Control Manager with demonstrated expertise in both in-process product testing and microbiological testing to lead our Quality Control (QC) team. This pivotal role ensures that our products consistently meet strict quality, safety, and regulatory standards at every stage—from raw materials and in-process checks to final release. The ideal candidate will leverage robust data analysis, collaborate across departments, and drive continuous improvement initiatives.

Key Responsibilities

1. Microbiological Testing & Compliance

• Oversee routine and specialized microbiological testing (e.g., sterility, bioburden, environmental monitoring) to ensure compliance with global standards (ISO 11737, ISO 10993, USP Class VI).
• Develop, implement, and maintain SOPs for microbiological protocols, ensuring all documentation is accurate and up to date.

2. In-Process Product Testing

• Lead the implementation of in-process quality checks throughout the manufacturing cycle to monitor critical parameters and detect potential deviations early.
• Collaborate with Production, Engineering, and R&D teams to optimize testing protocols, identify process bottlenecks, and minimize product defects or rework.

3. Quality System Management

• Formulate and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, GMP, and other relevant regulatory requirements.
• Conduct regular internal audits and manage external audits/inspections to ensure consistent compliance and swift resolution of non-conformances.

4. Regulatory Compliance

• Liaise with regulatory bodies to keep certifications, licenses, and approvals current.
• Proactively stay informed about industry regulations and guidelines, integrating necessary updates into company practices.
• Collect and analyze quality data (including microbiological and in-process testing results) to identify trends, measure performance, and drive evidence-based decisions.
• Coordinate corrective and preventive actions (CAPA) to address root causes of quality issues and foster ongoing process improvements.
• Partner with cross-functional teams (Production, Marketing, Supply Chain) to ensure insights gleaned from QC data inform product design, production optimization, and market positioning.
• Conduct risk assessments (e.g., FMEA) to identify and address potential hazards, focusing on microbial contamination and manufacturing bottlenecks.
• Implement risk mitigation strategies to uphold product safety and integrity throughout the product life cycle.
• Supervise, mentor, and develop the QC team, instilling best practices in microbiological testing, in-process checks, and overall quality assurance.
• Organize training sessions for QC and production staff, promoting a culture of quality consciousness and regulatory compliance.

Qualifications and Skills

• Bachelor's or master's degree in Pharmacy, Microbiology, Biotechnology, Biomedical Engineering, or related fields.
• Minimum 5 years of experience in quality control or quality assurance, with a strong background in microbiological methods and in-process product testing in the medical device or pharmaceutical industry.
• Proven track record of managing a QC team and handling quality-related projects end-to-end.
• Thorough understanding of microbiological testing (sterility, bioburden, environmental monitoring) and in-process inspection methodologies.
• Familiarity with ISO 13485, FDA QSR, and GMP requirements, as well as relevant testing standards
• Proficiency in data analytics tools (e.g., Excel, Minitab, Tableau) to generate actionable insights from quality data.
• Strong leadership, team-building, and communication skills to motivate and guide cross-functional teams.
• Excellent problem-solving and critical-thinking capabilities, particularly when interpreting complex data and identifying root causes.
• Detail-oriented with exceptional organizational skills, ensuring thorough documentation and compliance.

Interested candidates should send their resume to hr@sehat.ltd

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesMedical Equipment Manufacturing

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