Manager I, Quality Assurance Compliance
- Batam, Riau Islands
- Permanent
- Full-time
- Serve as the Self-Inspection Coordinator, managing planning, execution, reporting, and follow-up of self-inspection audits.
- Ensure audits are performed according to Quality System requirements; coordinate internal and external QMS audits (e.g., Corporate, Health Authority, Notified Body).
- Support external supplier audits.
- Act as Site Coordinator for the TrackWise-ACE Audit system, ensuring timely closure of audit reports and effectiveness of corrective/preventive actions.
- Represent the site in the Global Audit Community.
- Deliver training and qualification for self-inspection auditors.
- Lead the Management Review and Quality Council Meetings, including scheduling, documentation, and action tracking.
- Maintain and follow up on the Compliance Tracker.
- Participate in quality compliance improvement initiatives.
- Support IMPACD and external standards processes.
- Involved in product recall processes, including FAA and mock recalls.
- Perform additional duties as assigned.
- Comply with HSE (Health, Safety & Environment) policies and report HSE concerns as appropriate.
- Opportunity to work with a leading global medical device company.
- Collaborate with a diverse and talented team in a supportive work environment.
- Competitive compensation package and comprehensive benefits.
- Continuous learning and development opportunities.