Quality Compliance Specialist

4 months ago


Pasir Gudang, Malaysia Masimo Full time

**Job Summary**:
The Quality Compliance Specialist investigate customer complaints, make initial reporting decisions, facilitate investigations, and ensure completeness and consistency of the documentation for complaints.

**Duties & Responsibilities**:

- Investigate complaints daily:

- Responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow ups, maintaining investigation records and all other supporting documentations, and assign additional actions as necessary to close complaint.
- Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.
- Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
- Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
- Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
- Requests information from the customer related to complaint including the return of product(s) that are part of a system (i.e. sensor-cable-monitor).
- Review QPM trends related to complaints for potential trend.
- Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
- Evaluates each complaint if an investigation is required or not. Where investigation is needed, determine timelines with Failure Analysis Lab to ensure timely evaluation of product complaints and timely completion of reports. Reviews complaint investigation reports to ensure investigations are thorough and adequate and in accordance with procedures.
- Executes duties in compliance with established company policies.
- Develops a thorough understanding of the complaint database.
- Perform other duties or special projects as assigned.

**Minimum Qualifications and Experience**:
**Minimum Qualifications**:

- Ability to follow instructions and procedures and prioritize tasks.
- Ability to compile information, summarize, and input into quality database.
- Fluent in English in writing and verbal communications.
- Highly organized and self-motivated individuals.
- Skills required:

- Ability to interact effectively on a team and with internal and external customers.
- Demonstrated excellent technical writing and verbal communication skills.
- Demonstrated independent worker with ability to focus, and able to prioritize and handle multiple tasks and responsibilities.
- Must be a self-starter, a “hands-on” individual who enjoys challenge and is dedicated to getting the job done with mínimal and/or no direction.
- Demonstrated attention to detail, strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
- Logical approach to decision making.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
- Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level_



  • Pasir Gudang, Malaysia Food Excellence Specialist Sdn. Bhd. Full time

    **Responsibilities**: - Manage a team of quality supervisors and inspectors to ensure good quality products. - To support in inspector recruitment process - Manage the quality team for continuous quality improvement and achieve customer satisfaction. - Work closely with Production team to ensure quality control are within specification and good quality is...


  • Pasir Gudang, Malaysia Masimo Full time

    **Job Summary**: As a Trade Compliance Officer, you will be responsible for ensuring that our company complies with all national and international trade regulations. You will play a critical role in mitigating legal and financial risks associated with cross-border transactions and trade activities. The Trade Compliance Officer will work closely with various...

  • Operator (Quality)

    4 months ago


    Pasir Gudang, Malaysia Alfagomma Malaysia Sdn Bhd Full time

    **Role And Functions** Quality control technicians are responsible for testing materials and finished products to ensure they conform to all applicable laws and company standards. Quality control technicians test products across the three stages of production (before, in-process, and final) to ensure quality levels are met **Main Duties And...

  • Quality Assurance

    4 months ago


    Pasir Gudang, Malaysia Shang Wei Industries Sdn. Bhd Full time

    **Key Responsibilities**: 1. To coordinate the company’s quality control program while adhering to all policies and standard operating procedures related with ISO. 2. To establish quality & food safety specification / standard for production implementation. 3. To assist Production Manager for production process control related activities. 4. Handling...

  • Manager, Quality

    3 months ago


    Pasir Gudang, Malaysia Masimo Full time

    **Job Summary**: The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems, regulatory requirements, and continuous improvement...


  • Pasir Gudang, Malaysia CAHAYA AULIA SDN. BHD. Full time

    1. Gaining an understanding of the client's needs and requirements and communicating them and the quality standards to the production teams. 2. Devising ways to improve the manufacturing process to ensure Higher-quality goods. 3. Devising, improving, and reviewing new specifications and Procedures for products or processes, and training staff to use them. 4....

  • Quality Inspector

    4 months ago


    Pasir Gudang, Malaysia Alfagomma Malaysia Sdn Bhd Full time

    **ROLE AND FUNCTIONS** **MAIN DUTIES AND RESPONSIBILITIES** - Inspect all production processes are in compliance with set product parameters as per product specification - Carry out daily the catenary test at spooling area in accordance with company Instruction - Carry out hose measurement at braider process to comply with product specification - Issue...


  • Pasir Gudang, Malaysia FFM Berhad Full time

    **FFM Grains & Mills Sdn Bhd** **Location: Pasir Gudang, Johor** **Main Responsibilities**: To assist the Head of Quality Control Department to carry out and coordinate **quality control and quality assurance** activities of **wheat flour products** that include: - To assure the functionality of lab equipment and accuracy of lab testing. - To ensure the...


  • Pasir Gudang, Malaysia FOOD EXCELLENCE SPECIALIST SDN BHD Full time

    Experience in Waste Water Treatment Plant at least 2 years Cert/Diploma in Engineering courses Able to work in any situation Job Description as below: Control equipment and monitor processes that remove or destroy harmful materials, chemicals, and microorganisms from wastewater. Run tests to make sure that the processes are working correctly. Keep records of...


  • Pasir Gudang, Malaysia MSM Sugar Refinery (Johor) Sdn Bhd Full time

    **Qualifications** - Degree in Food Science or other related discipline. - Minimum 10 year working experience in food industry. - Systematics, organized and attention to details. - Professional, positive attitude, team player. - Sound knowledge in Food Safety & Quality System Management, including ISO 9001, HACCP, FSSC 22000. - Good knowledge in Good...


  • Pasir Gudang, Malaysia MSTS Asia Sdn Bhd (Johor Training Center) Full time

    We are a Global Partner to Safety Critical Industries, providing safety training to Oil & Gas, Energy, Marine and other companies that requires our services. We are now looking for **ONE **intern student to provide support in administrative duties, upkeeping and maintaining relevant documents on compliance and quality related documents and...


  • Pasir Gudang, Malaysia MSTS Asia Sdn Bhd (Johor Training Center) Full time

    We are a Global Partner to Safety Critical Industries, providing safety training to Oil & Gas, Energy, Marine and other companies that requires our services. We are now looking for **ONE **intern student to provide support in administrative duties, upkeeping and maintaining relevant documents on compliance and quality related documents and...

  • Wwtp Operator

    4 months ago


    Pasir Gudang, Malaysia FOOD EXCELLENCE SPECIALIST SDN BHD Full time

    Experience in Waste Water Treatment Plant at least 1 years SKM Cert/Diploma in Engineering courses Able to work in any situation Job Description as below: - Control equipment and monitor processes that remove or destroy harmful materials, chemicals, and microorganisms from wastewater. - Run tests to make sure that the processes are working correctly. - Keep...


  • Pasir Gudang, Malaysia ManpowerGroup Full time

    **Title : Customer Service Specialist** **Working hours **:Mon-Thurs (830am-6pm), Fri (830am-5pm) **Purpose of the job** - To responsible of customer service and management support **Key Tasks** - Frequent contacts with customers, serving customers inquiries - Order management, input order thru system - Maintain & update price list - Maintain & update...


  • Pasir Gudang, Malaysia Upright Talent Full time

    **Your Roles.** - Supervise lab staff, training, scheduling, and performance. - Ensure testing meets company and regulatory standards. - Implement quality control procedures for accuracy. - Analyze and communicate test results. - Maintain and calibrate lab equipment. - Manage inventory and order supplies. - Ensure health and safety compliance. - Collaborate...


  • Pasir Gudang, Malaysia MALAYSIA MARINE AND HEAVY ENGINEERING SDN BHD Full time

    JOB PURPOSES - Responsible to supervise the operation of the laboratory and ensure water quality complies with environment DOE requirements. (Environment Act 2005 JOB RESPONSIBILITIES - To manage and operate a lab operation for IETS and STP. - Responsible for overseeing the day-to-day operations of the laboratory including managing laboratory resources,...

  • Quality Control

    3 months ago


    Pasir Gudang, Malaysia Hiredly X Full time

    Responsible for the QA/QC functions of the Company in accordance to quality objectives, standards and good manufacturing practices set by the Company. Plan and conduct the analysis, inspection, design, test, and/or integration to assure the quality of the products, material or component throughout all phases of processes namely incoming, in-process and...


  • Pasir Gudang, Malaysia Agensi Pekerjaan Sunrise Recruit Sdn Bhd Full time

    Job Responsibilities: - Establish, implement, and conduct quality assurance and environmental, health, and safety training programs. - Perform internal audits, administer external audits, and manage on-site coordination of ISO certification. - Develop and enforce safety standards and policies to prevent accidents and occupational health risks. - Purchase...


  • Pasir Gudang, Malaysia ManpowerGroup Full time

    Purpose of the job To responsible of customer service and management support Key Tasks - Frequent contacts with customers, serving customers inquiries - Order management, input order thru system - Maintain & update price list - Maintain & update customer master file - Sample arrangement & coordination - Support customer to perform online ordering - Performs...


  • Pasir Gudang, Malaysia Vance Bioenergy Sdn Bhd Full time

    **Responsibilities**: - Assist Head of Department to determine any relevant management system, establish the scope, policy, objective, implement, maintain and continually improve the company management system in order to provide product and services that meet customer satisfaction, applicable legal requirements and confirms to the International Standard....