Quality Manager

**Job Summary**:
Responsible for development, implementation and maintenance of all QMS aspects of the Quasar Medical Singapore.

**Essential Duties and Responsibilities**:
Include the following. Other duties may be assigned.
- Serve as the Management Representative who has the responsibility and authority to:

- Ensure that quality system requirements are effectively established and effectively maintained in accordance with ISO 1348521 CFR Part 820 and customer’s requirements.
- Report to top management on the performance of the QMS and any need for improvements.
- Promote awareness of regulatory and customer requirements throughout the organization and ensure employee compliance to those requirements.
- Provide leadership and direction to the plant in relation to all QA matters, including quality systems and compliance, material disposition, etc.
- Liaise with Customer’s Representative and certification body for 3rd party audit.
- Ensure management review meeting is conducted to meet the regulatory requirements.
- Perform gap analysis for all changes to corporate policies and procedures as well as changes to applicable documents from other sister sites with potential impact to the plant operations.
- Control documents and records related to products, manufacturing processes and the quality system.
- Manage, plan and perform internal quality audits to ensure compliance to ISO 13485, ISO 9001, 21 CFR Part 820 and documented quality management system.
- Ensure timely review of LHR and release of finished products upon completion of testing and inspection.
- Ensure all corrective and preventive actions are developed and effective to resolve the non-conformances found.
- Drive and implement continuous improvements to enhance quality systems compliant and participate in related cross-functional projects.
- Monitoring of CAPA, customer complaints and feedbacks.
- Responsible to ensure Quality Control operations are effective and efficient.
- Responsible to ensure Quality records are complete and accurate.
- Review and approve all suppliers of components, raw materials, products, and services which become part of the final product and which directly affect the product quality. Assist in the assessment/ certification of critical suppliers _. _

**Authority**:

- Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- To stop production or shipment when there is product Quality issue.
- Ensure environmental aspect and safety hazard risk assessments are identified, reviewed, carried out to remove or control the risks to their respective staff at the workplace.
- Approve department environmental aspect, Risk Assessment and Safe Work Procedure if the risk is within acceptable level.
- Provide and maintain a work environment which is safe and without risk to health for employees at work.
- Report immediately all occupational accidents & incidents to the company and relevant parties and support the EHS Committee Management Representative in conduct of incident/accident investigation as appropriate.
- Initiate and/or approve disposition actions for EHS nonconformance as well as corrective/preventive actions to prevent recurrences
- Ensure that environmental, health & safety policies are upheld, EHS objectives and metrics are monitored, corrective/ preventive actions taken on EHS system defects are effective and properly closed.
- Responsible for the safety, health and well-being of workers under their charge.
- Provide support in EHS internal and external audits.
- To enforce compliance to company’s EHS management system and relevant legal and other applicable EHS requirements.
- To delegate task/s to his/her subordinates.
- To stop any unsafe work or negligent act that may endanger personnel.
- To investigate and analyse any incidents that occurred within his/her charge.

**Education/Experience and Qualifications**:

- 5-10 years of progressive responsibilities in quality assurance and control in medical device manufacturing or equivalent. In depth experience in medical device manufacturing, quality systems, quality assurance, quality control.
- Proven management skills.
- Knowledge ofISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directives;
- Demonstrated proficiency utilizing engineering tools (i.e., FMEA, DOE, SPC, statistical tools, etc.);
- Ability to perform activities to support product development, manufacturing, and release as identified by Senior Management;
- Excellent technical writing and verbal communication skills;
- Ability to work with all levels of Company personnel;
- Must be able to travel for assessments and other activities with critical Company suppliers.

**Work Environment**:
While performing the duties of this Jo