QA/QC Expert â ISOâ¯9001
QA/QC Expert â ISOâ¯9001
Posted on :
08-07-2025
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1 Vacancy
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Job Description
Position Overview
The QA/QC Expert will ensure product and process quality through effective implementation and maintenance of the Quality Management System (QMS) in compliance with ISO9001:2015 relevant regulatory standards (e.g. cGMP) and internal policies. This role partners closely with manufacturing R&D suppliers and external auditors to uphold high levels of quality and compliance.
Key Responsibilities
- Maintain and enhance the QMS to ensure compliance with ISO9001:2015 and regulatory requirements.
- Plan execute and follow up on internal and external audits including ISO19011-based internal audits.
- Develop and oversee quality documentationSOPs protocols reports risk assessments (e.g. FMEA) CAPAs nonconformance investigations.
- Collaborate with manufacturing engineers on process validation control software validation and training.
- Analyze quality data and metrics generate insights and drive corrective/preventative actions.
- Lead supplier quality and inspections facilitate root-cause analysis and manage supplier CAPAs.
- Support equipment qualification calibration/timeline management and environmental monitoringaligned with cGMP expectations.
- Serve as quality liaison during customer and regulatory audits; manage complaint handling and quality issue resolution.
- Promote continuous improvement initiatives and a culture of quality across the organization.
Required Qualifications
- Bachelors degree in Engineering Life Sciences or related discipline.
- 5 years of experience in quality assurance/control roles within biotech medical device or pharmaceutical manufacturing.
- Expertise in ISO9001:2015 implementation maintenance and internal auditing (ISO 19011).
- Thorough understanding of QMS risk management (FMEA) CAPA and change control methodologies.
- Experience with process and software validation equipment qualification calibration and environmental monitoring.
- Strong analytical abilitiesstatistical analysis of quality metrics and data interpretation.
- Excellent communication and cross-functional collaboration skills.
- Demonstrated ability to manage customer and regulatory audits.
- Preferred: experience in cGMP and FDA-regulated environments.
Desired Attributes
- Certified Quality Auditor (CQA) or Quality Engineer (CQE).
- Certification or formal training in ISO9001:2015 ISO19011.
- Six Sigma or Lean certification.
- Experience working in global or matrixed organizations.
- Proficient with QMS and data analysis software/tools.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Employment Type
Full Time
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