QMS Production Manager

1 week ago

Nonthaburi, 12, ไทย PRTR Group Public Company Limited เต็มเวลา

ฟรีด้วยอีเมลหรือ Google

บันทึกงานนี้และจัดระเบียบการค้นหาของคุณ

สร้างบัญชีฟรีเพื่อบันทึกงาน สร้างการแจ้งเตือน และกลับมาที่รายการนี้จากแดชบอร์ดของคุณ

บันทึกงาน บันทึกและสร้างการแจ้งเตือน

ฟรีด้วยอีเมลหรือ Google

Our client is one of the leading manufacturers of medical devices and is seeking a qualified candidate for the position of Production Manager to join their team.

Job Description

- Lead and maintain the site’s Quality Management System (QMS) in compliance with ISO 13485, GMP, regulatory requirements, and company standards.
- Drive quality compliance initiatives across manufacturing operations, ensuring procedures, records, and documentation are accurate, complete, and audit-ready.
- Manage quality system processes, including CAPA, NCR, deviation management, change control, risk assessment, document control, and continuous improvement activities.
- Oversee the development, review, implementation, and maintenance of SOPs, work instructions, forms, and quality-related documentation.
- Act as the key coordinator for internal audits, external audits, customer audits, and regulatory inspections, ensuring timely closure of findings and corrective actions.
- Monitor quality performance indicators, identify compliance gaps, and implement corrective and preventive actions to improve operational effectiveness.
- Collaborate closely with the Plant Manager, Production, Engineering, Quality Control, and cross-functional teams to integrate quality requirements into daily operations.
- Lead investigations related to quality issues, non-conformances, customer complaints, and process deviations, ensuring effective root cause analysis and sustainable corrective actions.
- Support employee training programmes on GMP, ISO 13485, quality systems, and documentation practices to strengthen the quality culture across the organisation.
- Prepare and maintain quality reports, audit reports, management review data, and compliance metrics for leadership review.
- Drive continuous improvement projects to enhance quality system effectiveness, compliance performance, and operational efficiency.

Qualifications:

- Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, Life Sciences, Quality Management, or a related field.
- Minimum 10 years of experience within medical device, pharmaceutical, or highly regulated manufacturing environments.
- At least 3 years of experience in a managerial or supervisory role.
- Strong hands-on experience with ISO 13485 and Quality Management Systems.
- Solid knowledge of CAPA, NCR, deviation management, change control, document control, risk management, and audit management.
- Proven experience in managing internal, external, customer, and regulatory audits.
- Strong understanding of GMP requirements, quality compliance, and regulatory expectations within medical device manufacturing environments.
- Good command of English, both written and spoken.

QMS Production Manager

บันทึกงานนี้และจัดระเบียบการค้นหาของคุณ

งานคล้ายกันใน Nonthaburi

งานที่คล้ายกัน

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เอเชีย / โอเชียเนีย

แอฟริกา

QMS Production Manager

บันทึกงานนี้และจัดระเบียบการค้นหาของคุณ

งานคล้ายกันใน Nonthaburi

งานที่คล้ายกัน