Quality/System Manager (Location: Batam)
Responsibilities
• Act as the Quality Management Representative of the company.
• Ensure effectiveness and compliance to ISO/IATF/QMS and various regulatory requirements as needed.
• Lead site quality team to drive operation and product quality improvements via data driven metrics.
• Oversee and support supplier quality, SCAR, product inspection, equipment calibration, CAPA, complaint investigation, change control, LMS training, and NPI activities.
• Chair quality management reviews and manage Internal & External audits.
• Support global quality system process integration, harmonization, and simplification. Managing local implementation and changes.
• Escalate and manage any significant events such as safety, product shipping holds due to quality, regulatory, or any compliance issue.
• Lead or support identified special projects and key initiatives as needed.
• Work cross-functionally to achieve Batam/Singapore site objectives.
Requirements
• Min. Degree in Quality Assurance, Manufacturing or equivalent.
• Min. 5 years of experience in Quality Management Systems in the plastic injection moulding or medical device industry for IATF16949, ISO9001, ISO14001 and ISO13485.
• Knowledge of regulatory requirements and standards relevant to manufacturing such as ISO45001/OHSAS18001 and ISO14001
• Strong customer focus with complaint investigation, significant event reporting and CAPA skills.
• Internal Auditor certification.
• Strong data analysis skills and proficiency in electronic data management systems.
• Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Location: Batam, Indonesia.
