**Reporting to ** : General Manager

**Subordinates**: 10+ (Quality)

**Total plant headcount**: 500

**Summary**
- As a member of the company’s and **global QARA leadership team,**
- To provide direction and lead the quality and facilities team.
- Responsible for **driving best-in-class Quality & regulatory compliance** as well premium product quality.
- Creates tactical plans and executes activities in accordance with the local and global procedures to meet the desired outcomes while establishing strong customer relationship.
- A “**hands-on**” leader who establishes a strong team to meet customer demands and optimizes design for manufacturability for quality and custom product lines, and the ability to drive continuous improvement and quality and compliance with 100% on-time delivery and zero defects.
- Responsible for establishing and achieving corporate and local QARA targets within the given budget.

**Requirements**:

- Bachelor’s Degree in Engineering
- At least 10 years of experience in a leadership roles and leading Engineering/Product Development teams
- Overall or end-to-end quality exposure. (Process Quality/ QARA/ SQE )
- Medical industry or related products experience is required.
- Global/ Regional Quality exposure is an added advantage for this role.

**Responsibilities**:

- Lead the Quality Team in developing continual quality improvements and ensure implementation and effectiveness of quality system are fulfilling the applicable quality and regulatory and customer requirements
- Assures quality products and processes by establishing and enforcing quality standards and testing materials and products.
- Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
- Develops raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures.
- Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures according to applicable regulations and customer requirements
- Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures according to applicable regulations and customer requirements
- Institutes rework standards by devising inspection and physical testing methods and procedures.
- Creates product quality documentation system by writing and updating quality assurance procedures according to applicable regulations and customer requirements
- Maintains product quality and compliance by enforcing quality assurance policies and procedures and government requirements according to applicable standards and regulations. Interfaces with local and government regulatory authorities as required.
- Collaborates with other members of the local and global management to develop new product and engineering designs and manufacturing and training methods.
- Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
- Completes quality assurance operational requirements by scheduling and assigning employees and following up on work results.
- Develops a strong quality & regulatory organization by recruiting, selecting, orienting, and training employees on all relevant QARA elements such as: Complaint Handling, CAPA, Auditing, Supplier management, statistical methods..
- Manages quality assurance staff job results by coaching, counseling, and disciplining employees.
- Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
- Achieves local and global objectives by preparing the quality and regulatory budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
- Establishes standard operating procedure according to applicable standard for the business and compliance to quality/regulatory requirements

**Salary**: RM20,000.00 - RM25,000.00 per month

Schedule:

- Monday to Friday

Supplemental pay types:

- 13th month salary
- Performance bonus