What are the responsibilities and job description for the Quality Control Engineer position at EnIn Systems?
Key Responsibilities:
- Perform in-process, final product, and raw material inspections to ensure conformance to specifications.
- Conduct analytical and functional testing using standard instruments and documented procedures.
- Maintain accurate quality records, including test results, deviations, and non-conformities.
- Work with the production and engineering teams to identify, report, and resolve quality issues.
- Participate in CAPA (Corrective and Preventive Actions), root cause analysis, and problem-solving activities.
- Support internal and external audits by preparing documentation and assisting with inspections.
- Ensure adherence to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Review and update Standard Operating Procedures (SOPs) and work instructions.
- Monitor quality metrics and participate in continuous improvement initiatives.
Required Skills & Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, Chemistry, or a related field.
- 2 years of experience in a Quality Control or Quality Assurance role.
- Knowledge of quality standards such as ISO 9001, ISO 13485, or FDA 21 CFR Part 820.
- Experience using laboratory equipment such as pH meters, spectrophotometers, HPLC, etc.
- Strong analytical, documentation, and communication skills.
Preferred Qualifications:
- Experience in pharmaceutical, biotech, food, or medical device industries.
- Working knowledge of LIMS, SAP, or electronic QMS tools.
- Certification in CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is a plus.
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