QC Engineer

Job Description (JD) for QC Engineer - Pharma Machine Manufacturing Industry

Position Title: QC Engineer
Department: Quality Control (QC)
Location: Ahmedabad
Reports to: Quality Control Manager / Head of Quality

Position Overview:

The QC Engineer is responsible for ensuring that pharmaceutical machinery and equipment manufactured meet quality standards and regulatory requirements. This role involves overseeing the testing and inspection of machines during the manufacturing process, as well as identifying, documenting, and resolving quality issues. The QC Engineer plays a key role in maintaining quality control processes and ensuring compliance with GMP (Good Manufacturing Practices) and industry-specific regulatory standards.

Key Responsibilities:

1. Quality Inspection & Testing:
   
• Perform detailed inspections and tests on pharmaceutical machinery, components, and subassemblies at various stages of production.
• Verify compliance of manufactured machines with customer specifications and regulatory standards.
• Use precision measuring instruments (e.g., micrometers, calipers, gauges) to assess machine parts for quality.
• Conduct functional tests to ensure the machines perform as expected.
2. Documentation & Reporting:
   
• Prepare and maintain detailed records of inspections, tests, and quality control procedures.
• Document non-conformance issues and provide detailed reports, including findings and corrective actions.
• Create quality control certificates and product release documentation for each unit before shipping.
• Maintain audit trails and assist with internal and external quality audits.
3. Compliance with Regulatory Standards:
   
• Ensure that all machinery meets the necessary regulatory requirements (such as FDA, CE, GMP standards) for pharmaceutical manufacturing equipment.
• Review design specifications and ensure that the manufacturing process aligns with these specifications and quality standards.
• Stay updated on relevant regulatory changes and implement adjustments to quality control practices as needed.
4. Root Cause Analysis & Corrective Actions:
   
• Investigate defects, customer complaints, and manufacturing errors to determine the root cause.
• Work closely with the production and engineering teams to implement corrective and preventive actions (CAPA) to prevent recurrence.
• Collaborate with suppliers to address quality-related issues with raw materials and components.
5. Continuous Improvement:
   
• Assist in the development and improvement of quality control procedures and methodologies.
• Participate in continuous improvement initiatives, including Six Sigma and lean manufacturing projects, to optimize quality processes.
• Monitor quality metrics and report on performance trends to upper management.
6. Product Testing and Validation:
   
• Perform validation and qualification testing on new machinery to ensure conformity with design and regulatory requirements.
• Validate and document equipment calibration, ensuring accurate performance over time.
• Collaborate with R&D and engineering teams during the prototype and pilot runs to ensure adherence to quality standards.
7. Supplier Quality Assurance:
   
• Assess and evaluate suppliers of components and materials used in pharmaceutical machinery.
• Conduct supplier audits and inspections to ensure that their products meet company quality standards.
• Provide feedback and recommendations for improving supplier quality performance.
8. Team Collaboration:
   
• Collaborate with the production and engineering teams to address quality concerns and ensure smooth production processes.
• Train production staff on quality control procedures and help them adhere to company quality standards.
• Participate in cross-functional meetings to ensure alignment on quality goals and continuous improvements.

Skills & Qualifications:

• Education: Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related field. Additional certifications in Quality Management (e.g., ISO 9001, Six Sigma) are a plus.
• Experience: Minimum of 3-5 years of experience in quality control or quality assurance in a manufacturing environment, preferably in the pharmaceutical, medical device, or machinery manufacturing industry.
• Knowledge:
  
• Strong understanding of quality control principles, testing methods, and regulatory standards in the pharmaceutical machine manufacturing industry.
• Familiarity with GMP, FDA, ISO standards, and CE certification processes.
• Proficiency in quality control tools such as root cause analysis, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), and CAPA.
• Skills:
  
• Excellent problem-solving skills and attention to detail.
• Strong communication skills to document findings and collaborate with cross-functional teams.
• Knowledge of precision measurement tools and testing equipment.
• Ability to work independently and in teams to achieve quality objectives.
• Certifications: ISO 9001 Auditor, Six Sigma Green Belt/Black Belt, or other quality-related certifications are desirable.

Working Conditions:

• Full-time position with standard working hours.
• Ability to work in a manufacturing environment with exposure to machinery, tools, and controlled environments.
• Some travel may be required to visit suppliers or customers for audits and inspections.