Associate QA Manager

Job Description:

Key Responsibilities:

• Act as Quality Management Representative of affiliates.
• Execution of Product Shiphold, Field Safety Corrective Actions as per instructions from Regional or Corporate office.
• Provision of training to employees on quality related documents and policies
• Responsible and be accountable for external, internal and supplier audit in South East Asia and the follow-up remediation plan.
• Co-ordinate and host the Quality Management Review Meeting in South East Asia.
• Identifies quality system problems, provides recommendations and resolutions.
• Manages the document control for all procedures and quality records
• Ensures all the Procedures are in place and the appropriate personnel have been trained on them.
• Interacts on a periodic frequency with Supply Chain, Technical Service and Education function on all quality related matters.
• Provides support to ensure that product labeling activities meets local and corporate/OUS quality & regulatory requirements
• Ensures that any changes to the Corporate Quality Manual and the OUS Quality Procedures are interpreted and implemented

with the local Country manual and procedures where applicable.

• Preparation of audits conducted by both internal and external bodies.
• Manage the change control process to meet amendment to local regulatory compliance requirements.
• Prepare and help to maintain applicable Quality related certification in the region.
• Be involved in the Risk Management and conduct CAPA process

Other Functions And Responsibilities

- Handle and process customer feedbacks/complaints/product experience in timely manner and according to Abbott Global

Commercial Quality System, Abbott Medical Asia’s and Abbott Medical country’s policy and requirement

- Execute the job responsibilities according to applicable standard operating procedures of Abbott Global Commercial Quality

System, Abbott Medical Asia and Abbott Medical Country Affiliate

- Ensure applicable standard operating procedures of Abbott Global Commercial Quality System, Abbott Medical Asia and

Abbott Medical Country Affiliate are executed

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

Job Family:

Regulatory Operations

Division:

EP Electrophysiology

Location:

Thailand > Bangkok : Rasa One, Building B, 17th Floor, Unit 1704 555 Phaholyothin Rd

Additional Locations:

Work Shift:

Standard

Travel:

Yes, 5 % of the Time

Medical Surveillance:

Yes

Significant Work Activities:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)