Supervisor, Manufacturing (Medical device background preferred)

Masimo.; Pasir Gudang; On-site; MYR 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Manufacturing Supervisor to oversee daily operations in a dynamic environment. This role is critical in ensuring that production meets the highest standards of quality and customer satisfaction while adhering to regulatory requirements. The ideal candidate will have a strong background in manufacturing supervision, effective communication skills, and knowledge of ISO standards. Join a forward-thinking company where your leadership will drive efficiency and excellence in manufacturing processes.

Qualifications

• Minimum 2 years of supervising experience in manufacturing.
• Strong communication skills for interaction with various teams.

Responsibilities

• Supervise manufacturing personnel and ensure compliance with quality regulations.
• Collaborate with engineering departments to document assembly steps.

Skills

Supervising experience

Effective communication skills

Knowledge of ISO 13485

Experience with CGMP and FDA

Experience with electrical/optical products

Education

Bachelor’s degree in industrial engineering

Job description

Supervisor, Manufacturing (Medical device background preferred)

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The Manufacturing Supervisor is responsible for the day-to-day supervision of all manufacturing personnel within their department. This position ensures build plans are achieved with the highest level of customer satisfaction and quality, while also ensuring compliance with all regulatory and quality regulations.

Duties & Responsibilities:

• Comply with procedures defined in the Quality System, Company Policies, and Malaysian Labor Law.
• Supervise hiring, training, and performance of associates and leads.
• Collaborate with Quality and Process engineering departments to document product assembly steps and acceptance criteria in manufacturing documentation (MAP and APs) and visual aids.
• Ensure manufacturing lines have appropriate documentation, visual aids, and physical visual aids accessible at each process workbench for product acceptance reference.
• Adhere to procedures and good manufacturing practices.
• Meet production schedules within efficiency and yield goals; achieve company metrics.
• Ensure Line Balancing documentation is available and work with leads, process engineers, and industrial engineers to optimize workload distribution, improve efficiency, reduce bottlenecks, and minimize downtime.
• Perform disciplinary sanctions according to internal regulations.
• Supervise proper material identification and segregation (raw materials and finished products).
• Elaborate reports as requested by Management.
• Support company activities and projects.
• Report unsafe conditions or actions.
• Maintain a clean and orderly workplace.
• Ensure personnel wear personal safety equipment and comply with ergonomic and personnel rotation requirements.
• Investigate non-conformant product causes and implement preventive actions.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• At least 2 years of supervising experience.
• Effective written and oral communication skills to interact professionally with co-workers, subordinates, Engineering, and Quality Assurance.

Preferred Qualifications:

• Knowledge/experience with ISO 13485 requirements and Quality System Regulation.
• Experience with CGMP, FDA, and ISO medical device requirements.
• Experience with electrical/optical products.

Education:

Bachelor’s degree in industrial engineering or equivalent experience.

Physical requirements/Work Environment:

This role primarily involves office and manufacturing/production environments. It requires frequent sitting, standing, and walking, as well as daily use of computers and digital devices. Extended standing during meetings or facility walkthroughs is common. Some local travel is necessary, requiring a valid driver’s license.

The physical demands are essential functions; accommodations may be provided for disabilities.