Quality Assurance Engineer

QA Engineer (Calibration & Environmental Monitoring)

Requirement:

• Bachelor's Degree in Engineering, Biomedical Eng., Quality Eng., Science, or related scientific discipline.
• Basic understanding of ISO 13485:2016 Quality Management System
• Familiarity with Good Documentation Practices (GDP)
• Basic knowledge of environmental monitoring for controlled manufacturing areas (cleanroom/ISO 14644)
• Familiarity of CAPA, change control, risk management principles is an added advantage.
• Good analytical & problem solving skills
• Meticulous & strong attention to details

Scope of Duties

1.Quality Management System

• Apply and maintain compliance with ISO 13485:2016 and applicable regulatory requirements (US FDA QMSR, Japan PMDA)
• Drive continuous improvement across quality system processes & ensure practices align with customer and statutory requirements

2.Calibration Management

• Coordinate the full calibration program across the facility, including scheduling with internal and external service providers
• Maintain the calibration master list to ensure all measuring equipment is calibrated on time
• Review calibration certificates for completeness, traceability, and compliance
• Update & maintain accurate calibration records within the QMS
• Identify, quarantine, and support impact assessment for overdue or failed calibration status equipment
• Assist in developing and revising calibration procedures and work instructions.

3.Environmental Monitoring

• Perform routine environmental monitoring in controlled manufacturing areas according to established procedures.
• Record, review and trend environmental monitoring data.
• Investigate environmental monitoring excursions and support corrective and preventive actions (CAPA).
• Coordinate maintenance and calibration of environmental monitoring instruments.
• Ensure environmental monitoring records are complete.

4.Quality Assurance Support

• Maintain quality records in accordance with document control requirements.

• Support internal audits, external audits and regulatory inspection.

• Participate in investigations related to calibration and environmental monitoring deviations.

• Assist with change control, risk assessments, CAPA, and nonconformance activities.

• Support validation, qualification and continuous improvement activities as required.

• Ensure compliance with company policies, Good Documentation Practices (GDP), and applicable regulatory requirements.

5.Authority

• Authorized to review calibration and environmental monitoring reports.
• Authorized to stop the use of measuring, test, inspection, or monitoring equipment that is overdue for calibration, out of calibration, damaged, or otherwise unsuitable for use.
• Authorized to place equipment on hold or quarantine pending calibration, repair, investigation, or disposition.
• Authorized to suspend manufacturing activities in controlled areas when environmental conditions exceed established limits and may impact product quality or regulatory compliance.
• Other authority as defined in Limit of Authority.

6.Other Responsibilities

• Perform any additional duties assigned by QAQC Manager and/or Management that support departmental and organizational objectives.

Benefits include:

• Regular working hour from 8 am to 5 pm Monday - Friday (option to apply for flexi hour)
• Attractive salary offered based on experience & skills
• Reimbursement on mileage, toll & business trip
• Free & wide parking area
• Meal, attendance & phone allowances
• Corporate insurance GHS & GPA
• Medical benefits which include GP, dental & optical
• Other miscellaneous allowance