Total 2 Account Executive job vacancies in Quality Assurance / Control category in Selangor

Responsibility:

1)      Project Development

• Development of equipment, jig and tool drawings.
• Testing to check the suitability of the products together with Production Engineer.
• Preparation of customer’s documentation.
• Etc.

 

2)      Production Process

• Setup new production method and process.
• Monitor and improve the current production method and process.
• Monitor in-process product in production area to ensure quality products are delivered to the customers.
• Record and analyze the production rejection rate on all items.
• Etc.

 

3)      Quality Issue and Improvement

• To investigate customer complaints and non-conformance issues arise (internal
• To develop, recommend and monitor corrective and preventive actions
• Preparation of document which is required by customer.
• Preparation of quality control plan, PFMEA and etc.
• Keep records of quality reports, statistical reviews and relevant documentation.
• Promote quality awareness and commitment to quality across the company and ensure all employees follow the quality requirements.
• Etc.

 

4)      Incoming & Outgoing Quality Documents

• Managing the incoming quality documents, ie COA, COC, Incoming Raw Material & Goods Check Sheet, etc.
• Preparation of Outgoing Quality Check Sheet.
• Etc.

 

5)      Calibration of Equipment, Jigs & Tools

• Monitor the schedule of calibration.
• Ensure the relevant parties are using the calibrated equipment, jig & tool and keep it properly.
• Etc.

 

6)      ISO Documentation and Audit Process

• Review and update relevant quality system procedures and work instructions.
• To coordinate and support on-site internal and external audits.
• To evaluate audit findings and implement appropriate corrective actions.

 

7)      Chemical Substances Management

• Consolidate the relevant information and documents, ie. ROHS report, ICP report, SOC report of the materials.
• Submission of relevant report to the customer.
• In charge of chemical handling & abnormalities.
• Ensure chemical management awareness on the shop floor.

 

8)      Any other tasks assigned by the Management from time to time.

 

Authority:

1. Release of new inspection jig.
2. Release of the calibrated measuring equipment.
3. Release of finished goods.
4. Suspend and stop the production process due to nonconformity and abnormality found.
5. Decide the action on the rejected parts that have a rejection rate is less than 3%.
6. Acknowledgement of Incoming Raw Material & Goods Check Sheet.

Perks & Benefits

• Commission and bonus
• Allowance (travel stipends, transportation, etc.)
• Casual dress code
• Medical insurance
• Personal leave

     

JOB DESCRIPTION:

PRIMARY OBJECTIVE:
Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and local regulations.

CORE JOB RESPONSIBILITIES:

• Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company
• Supports Complaint Handling/ post market surveillance and follow up actions
• Assignment of QMS training to employees on quality related documents and policies
• Preparation of monthly KPI data
• Provide inputs for Management Review Meeting including updates on adequacy and effectiveness of Quality Management system.
• Manages the document control for QMS procedures and quality records
• Support and prepare affiliate for Internal & External Quality & Compliance Audits.
• Prepare and help to obtain and maintain the GDPMD Certification and/or applicable Quality related certification in the region.
• Support external, internal and supplier audit and the follow-up remediation plan.
• Support investigation, defining root-cause and implementation of Corrective Action and Preventive Actions in a timely manner.
• Execution of Product Stop Shipment, Field Safety Corrective Actions as per instructions from Regional or Divisional QA.
• Interacts on a periodic frequency with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education and other functions on all quality related matters.
• Manage the change control process to meet amendment to local regulatory compliance requirements.
  OTHER FUNCTIONS AND RESPONSIBILITIES:
• Perform various administrative functions as required.
• Any other activities as assigned time to time by Line Manage

EDUCATION/QUALIFICATIONS/EXPERIENCE:

• Minimum of Bachelor’s degree in Science. Equivalent education/work experience will be considered.
• Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.
• Knowledge of local Medical Device regulations
• Computer proficiency in Word, Excel and PowerPoint.
• Strong interpersonal skills, with the ability to build and maintain relationships.
• Effective time management - well organized, able to set and reset priorities
• Strong oral and written communication skills.
• Detail and deadline oriented.
• Conversant local language as well both written and spoken English.
• Ability to work and flourish in a fast-paced multi-tasked environment
• Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
• Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.
• Good in English Communication Skills

EXPERIENCE REQUIRED:

• Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.

     

The base pay for this position is

N/A

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

AVD Vascular

        

LOCATION:

Malaysia > Selangor : Imazium, No. 8, Jalan SS 21/37

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)