Quality Manager

QUASAR MEDICAL GROUP HOLDING PTE. LTD.; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A medical device company in Singapore is seeking a Quality Assurance Manager to oversee quality management systems and ensure compliance with ISO 13485 and FDA regulations. The role requires at least 5 years of experience in medical device manufacturing, proven leadership skills, and the ability to conduct quality audits. A dynamic work environment that values safety and compliance awaits the ideal candidate.

Qualifications

• 5-10 years in quality assurance in medical device manufacturing.
• Proven management skills and ability to lead teams.
• Excellent communication skills.

Responsibilities

• Maintain compliance with ISO 13485 and FDA regulations.
• Conduct internal audits and manage corrective actions.
• Provide leadership in quality assurance initiatives.

Skills

Quality assurance

Regulatory compliance

Analytical skills

Leadership

Technical writing

Education

Degree in relevant field

Tools

Microsoft Office

FMEA

DOE

SPC

Job description

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.