JOB OVERVIEW

We are seeking a dedicated and detail-oriented Quality Engineer to join our team. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and compliance. This role involves collaborating with various departments to implement quality assurance processes, conduct inspections, and maintain adherence to industry standards such as ISO 9001 and ISO 13485. The Quality Engineer will play a crucial role in enhancing product reliability and customer satisfaction.

MINIMUM REQUIREMENTS:

1. Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
2. 3–5+ years of experience in Computer System Validation (CSV) within biotech, pharmaceutical, or medical device manufacturing.
3. Strong working knowledge of GMP, FDA 21 CFR Part 11, GAMP 5, ISO 9001, and data integrity principles.
4. Hands-on experience authoring validation protocols and reports (IQ, OQ, PQ) for laboratory and manufacturing systems.
5. Familiarity with risk assessment tools such as FMEA, as well as change control, CAPA, and audit procedures.
   PREFERRED REQUIREMENTS 1. ASQ Certification such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA). 2. Six Sigma or Lean Manufacturing certification or experience. 3. Solid organizational skills with a strong attention to detail. 4. Excellent written and verbal communication skills, including ability to work across functions and sites.
   Job Types: Full-time, Temporary

Education:

• Bachelor’s (Preferred)

Experience:

• Engineering: 3 years (Preferred)
• CSV: 3 years (Preferred)

Work Location: In perso

Please refer the Job description for details