Quality Engineer

Chamunda Pharma Machinery; Ahmedabad District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Chamunda Pharma Machinery seeks a QC Engineer / SQC to bridge internal manufacturing and vendor capabilities. You will lead source inspections at supplier sites and manage incoming quality control at the plant to drive zero defects in components and materials used in pharma machinery.

Responsibilities include conducting supplier audits, PPAP support, ensuring material traceability, and overseeing CAPA/SCAR processes while collaborating with QA/QC and production teams in a travel-heavy role.

Qualifications

• Bachelor's degree in Mechanical, Production or Mechatronics engineering.
• 3–6 years in QC/Supplier Quality within pharma machinery or similar.
• Strong knowledge of GD&T, welding inspection, and surface finish standards.
• Familiarity with cGMP, ISO 9001, ASME and GAMP.

Responsibilities

• Audit and assess vendor quality systems and parts.
• Perform source inspections and pre-dispatch checks.
• Drive PPAP and process validation; monitor CAPA/SCAR.
• Ensure material traceability and IQC at plant.

Skills

GD&T reading

Welding inspection

Surface finish knowledge

Regulatory compliance

Vendor negotiation

Travel readiness

Education

Bachelor’s Degree in Mechanical/Production/Mechatronics

Job description

Job Description: Quality Control (QC) Engineer Supplier & Incoming Quality

• Job Title: QC Engineer / Supplier Quality Control (SQC) Engineer
• Department: Quality Assurance & Quality Control (QA/QC)
• Industry: Pharmaceutical Machinery / Equipment Manufacturing
• Work Location: Plant-based with frequent travel to vendor/supplier locations (Source Inspection)
• Reporting To: Head of Quality / Quality Assurance Manager

Job Summary

The QC Engineer will bridge the gap between internal manufacturing requirements and external vendor capabilities. This role is responsible for driving quality standards at vendor manufacturing sites (Source/Stage Inspection) and managing rigorous Incoming Quality Control (IQC) at the plant. The objective is to achieve Zero Defects in bought-out components, raw materials (metals, polymers), and sub-assemblies used in pharma machinery, ensuring seamless compliance with pharmaceutical validation standards (IQ/OQ/DQ requirements, material traceability, and cGMP).

Key Roles & Responsibilities

1. Vendor-End Quality & Source Inspection

• Supplier Audits & Assessments: Conduct periodic quality system audits and technical evaluations of new and existing component vendors/machining shops.
• Source/Stage Inspection: Travel to vendor facilities to perform pre-dispatch inspections (PDI) and witness critical manufacturing stages (e.g., raw material verification, welding quality checks, dimensional analysis).
• PPAP & Process Validation: Drive Production Part Approval Process (PPAP) and ensure vendors follow strict quality control plans, manufacturing feasibility studies, and routing sheets.
• Vendor Development: Train and mentor vendor engineering teams on pharmaceutical machinery specifications, cleanroom standards, surface finish requirements (e.g., Ra values for SS parts), and welding standards (ASME Section IX/AWS).

2. Incoming Quality Control (IQC)

• Material Verification: Inspect incoming raw materials (SS 304, SS 316L sheets, pipes, bars) and bought-out mechanical, electrical, and pneumatic components against purchase orders, engineering drawings, and bill of materials (BOM).
• Dimensional & Metrology Checks: Use precision measuring instruments (Vernier calipers, micrometers, height gauges, surface roughness testers) to inspect machined components.
• Material Traceability: Verify and maintain material test certificates (MTCs), chemical composition reports, and mechanical test results (Mill Test Reports) to ensure full compliance with regulatory standards.

3. Non-Conformance Management & Continuous Improvement

• SCAR & CAPA Management: Issue Supplier Corrective Action Requests (SCAR) for non-conforming materials and lead Root Cause Analysis (RCA) using structured tools like 8D, Fishbone, and 5-Why.
• Cost of Poor Quality (COPQ): Monitor and track supplier rejections, scrap rates, and rework costs to minimize internal disruptions and financial losses.
• Vendor Rating: Evaluate suppliers monthly/quarterly based on quality performance, delivery adherence, and responsiveness.

Required Qualifications & Skills

• Education: Bachelor’s Degree in Mechanical Engineering / Production Engineering / Mechatronics.
• Experience: 3 to 6 years of core Quality Control / Supplier Quality experience, preferably within Pharma Machinery, Heavy Engineering, or Precision Machining industries.
• Technical Competencies:
  • Deep proficiency in reading complex engineering drawings, GD&T (Geometric Dimensioning and Tolerancing), and fabrication blueprints.
  • Thorough understanding of Welding Inspection (Visual inspection, Weld symbols, Radiography/NDT awareness for pressure vessels/reactors).
  • Knowledge of surface finish standards crucial for pharma (e.g., Electro-polishing, mechanical polishing, surface roughness measurement $Ra \le 0.5\,\mu\text{m}$).
• Regulatory Knowledge: Familiarity with cGMP, ISO 9001, ASME, and GAMP guidelines applicable to pharmaceutical equipment manufacturing.
• Soft Skills & Travel: Strong negotiation and communication skills for vendor handling; readiness to travel locally and outstation to vendor locations frequently (approx. 30–40% travel).

Key Performance Indicators (KPIs)

1. Incoming Rejection Rate (%): Reduction of defective parts received from vendors.
2. Vendor On-Time Quality Delivery (OTQD).
3. Effective Closure of SCARs/CAPAs: Turnaround time for investigating and resolving vendor-end quality failures.
4. Compliance Index: Zero audit observations related to raw material or vendor traceability during client/third-party FAT (Factory Acceptance Testing).