Production Manager Medical Device Manufacturing Senai

2 weeks ago

Johor Bahru, Malaysia Hirehub Management Sdn Bhd Full time

**Responsibilities**:

- Lead and manage daily production operations to ensure efficient, compliant, and timely manufacturing of medical devices.
- Oversee production planning, resource allocation, manpower supervision, and workflow optimization to meet output and quality targets.
- Ensure full compliance with relevant regulatory standards including **ISO 13485**, **FDA 21 CFR Part 820**, and internal quality systems.
- Develop and enforce SOP, work instructions, and manufacturing best practices in line with **GMP**.
- Coordinate with cross-functional teams (QA/QC, R&D, Supply Chain, Regulatory) to support new product introductions and continuous improvement initiatives.
- Lead root cause investigations and corrective/preventive actions (CAPA) for production-related non-conformities or deviations.
- Maintain production records and documentation to support **regulatory audits, including FDA inspections and ISO audits**.
- Monitor and report on key performance indicators (KPIs) including yield, downtime, scrap rate, and efficiency.
- Drive a culture of quality, safety, and operational excellence across the production floor.
- Provide leadership, training, and performance evaluation for production staff and supervisors.

**Requirements**:

- Bachelor’s degree in Engineering, Manufacturing, or a related field.
- Minimum 5-8 years of production management experience; experienced in the **medical device or pharmaceutical** industry is highly preferable.
- Strong understanding of **ISO 13485**, **FDA regulations**, **GMP**, and validation requirements.
- Proven experience in handling **regulatory audits**, especially **FDA inspections** and **ISO certification audits**.
- Excellent leadership, problem-solving, and communication skills.
- Ability to work in a fast-paced, detail-oriented, and compliance-driven environment.

**Additional Information**:

- Salary Range: RM8000 - RM1500
- Location: Senai Ipark / Taman Teknologi (2 companies)

**Job Types**: Full-time, Permanent

Pay: RM8,000.00 - RM17,000.00 per month

**Benefits**:

- Opportunities for promotion
- Professional development

Schedule:

- Monday to Friday

Supplemental Pay:

- Performance bonus

**Experience**:

- Production Management: 1 year (preferred)
- ISO Regulations: 1 year (preferred)
- FDA Audits: 1 year (preferred)
- People Management: 1 year (preferred)

**Language**:

- Mandarin (preferred)
- English (preferred)

Work Location: In person

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