Quality Assurance Manager

** Familiar in Medical related quality standards (ISo 13485)**
** Experience in managing large group subordinates (up to 10-20)**

**Responsibilities**:

- Lead the Quality Assurance Department in operating with a high level of efficiency, integrity, and enthusiasm, striving to achieve excellence in all endeavors.
- Be creative and proactive contributor on the management team, focused on continuous improvement.
- Recruit and maintain a high-caliber staff appropriate to business circumstances, as well as organizational structure, and product quality engineering team.
- Develop, motivate, and challenge all team members to perform to their full potential, providing direct and timely feedback in formal and informal media.
- Delegate and organize departmental workload according to diversity business assignments.
- Co-ordinate interaction between the Quality Department and all other manufacturing and support functions.
- Monitor and evaluate the level of involvement and success of the Quality Engineering activities and their impact on the continuous improvement of process yields and efficiencies. Provide the appropriate level of feedback, support, and coaching.
- Provide support to the Business Managers and maintain an active role in functions. Monitor the product acceptance levels (yields) as seen by the customer and ensure that appropriate preventive measures are taken.
- Ensure periodic Internal Quality Audit is done to measure the efficiency of the quality function.
- Evaluate and schedule appropriate training programs and/or seminar for the Quality Assurance staff, including direct employees.
- To read, understand and support the implementation of systems stated in all Quality Manuals.
- Collaborate with other function partners for any issues, including but not limited to quality, headcount sizing, resource allocation, as well as escalation path.
- Lead QS team and ensure QMS is in full compliance with applicable standard, regulation, and customer requirements such as ISO 9001, ISO 13485, US FDA, AS9100, Nadcap, TL9000, IATF 16949, ISO 27001, product regulatory requirement etc.
- Be a champion to lead and drive improvement for quality KPI, such as OBA (Out of Box Audit), Customer Complaint etc.
- Acts as site contact window and corporate with global team to deploy global requirements to site.
- Enhance quality culture and regulatory awareness by coaching BBQ SME to initiate BBQ (Behavior Based Quality) initiatives at defined intervals across plant wide.
- Takes overall responsibility and accountability of quality for both healthcare and non-healthcare product.
- Mentor QMS Manager to coordinate management review meeting at defined intervals and ensure effective closure of any management review output.
- Support any quality audits, such as external audit, including regulatory audit, customer audit, etc. toward zero Critical/Major finding.
- Be a part of team to drive implementation of ISO14001 & ISO45001 and its compliance.
- Be a part of team to drive and comply incident or accidents, save energy and fresh water, sort waste and reduce waste.
- Perform safety responsibility to supervise daily safety production and rectify EHS non-conformity.
- Must follow RBA (Responsibility Business Alliance Code of Conduct) provision.
- Supporting energy saving, sorting waste, and reducing waste.

**Requirements**:

- Bachelor’s degree in science or engineering with preferable at least 10 years of working experience in the quality related field is and 5 years of managerial experience.
- Proficiency and knowledgeable in all areas related to the QA function.
- Able to communicate clearly and effectively in both verbal and written media.
- Able to lead and coach all Quality Assurance personnel to enable them to be more independent and take ownership of their efforts.
- Familiar with the document control system and able to comprehend and implement changes.
- With the ISO 9001, ISO 13485, US FDA, AS9100, Nadcap, TL9000, IATF 16949, ISO 27001, product regulatory requirement etc and can lead in implementing programs leading to awareness and quality improvements.
- Familiar with the overall plant's operating procedures.

**Job Type**: Permanent

**Salary**: RM15,000.00 - RM20,000.00 per month

Schedule:

- Monday to Friday

Supplemental pay types:

- 13th month salary
- Performance bonus

Application Question(s):

- How many subordinates reporting to you?

**Education**:

- Bachelor's (preferred)

**Experience**:

- Internal Quality Assurance (IQA): 10 years (preferred)
- Medical products/ industry: 8 years (preferred)