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:

o Ensure that quality system requirements are effectively established and effectively maintained in accordance with ISO 1348521 CFR Part 820 and customer's requirements.

o 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.

• Computer literate in Microsoft Office applications

• 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 Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 10K/100K cleanroom) and office area.