Manager Quality Assurance

DUTIES & RESPONSIBILITIES:

Lead, review and ensure QA operations and system complied with Company, customer, regulatory, interested parties’ requirements.

• Responsible for the day-to-day management and co-ordination of all the quality functions to meet quality management system, regulatory and customer requirements.
• Developing and maintaining the quality system to ensure compliance with national/international standards and regulatory requirements; and quality system requirements, which includes but not limited to the following activities: -
• Maintaining quality system documentation,
• Resolving all the quality matters,
• Monitoring the quality system to comply with relevant standards and regulatory requirements.
• Quality Assurance/Regulatory Affairs Manager is appointed as Management Representative for:-
• Ensuring that all requirements outlined in quality manual are effectively implemented and maintained.
• Ensuring that processes needed for the quality management system are established, implemented and maintained in accordance to ISO 9001, ISO 13485, and US FDA 21 CFR Part 820 (QSR) and/or EU MDR & PPE Malaysian Medical Device Act 2012.
• Reporting to top management on the performance of the quality management system and any need for improvement.
• Ensuring the promotion of awareness of applicable regulatory requirements, customers’ requirements and quality management system requirements throughout the company.
• Constant and ongoing improvements to the Quality Management System (QMS)
• Review and ensure QA operations and system accuracy, so that staff is achieving the required competency and able to deliver accurate results, outcome and expected performance.
• Drive QA team to perform consistently as per target level, on top of the ability to meet define KPI.
• Responsibility to assure other management system documentation that applicable to the company is properly controlled, maintained and documented as per required under document control system.
• Ensure timely preparation and submission of international regulatory agency forms and filling as well as internal regulatory file documentation.
• Map and plan strategies and activities in line with the company’s Quality Policy and Objectives for QA Department.
• Ensuring timely written investigation reports of customer complaints and audit finding to ensure that appropriate actions to the complaints/ audit have been taken and reported to customer / certification body.
• Ensure all subordinates at all time are following the company policy and safety rules and regulations during operation.
• Review and ensure QA operations achieve the required productivity, headcounts and cost based on defined cycle time.
• Review and ensure product quality and measurements are able to perform consistently per target level, besides the ability to meet with standard, regulatory and customers’ requirements.
• Any other task and/or assigned duties as required by the management.

JOB REQUIREMENT:

• A bachelor’s degree or equivalent from an accredited College or University, preferably in Scientific or Engineering discipline, or Diploma or equivalent from an accredited College or university with eight years working experience, preferably in a QMS environment, is required.
• Knowledge of gloves manufacturing process, validation, audit, QMS, cGMP, FDA in a regulated environment is preferred.

Job Types: Full-time, Permanent

Pay: Up to RM10,000.00 per month

Benefits:

• Free parking
• Opportunities for promotion
• Professional development

Schedule:

• Day shift
• Fixed shift
• Monday to Friday

Supplemental Pay:

• Performance bonus
• Yearly bonus

Ability to commute/relocate:

• Jeram (45800, Kuala Selangor, Selangor): Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

• How many months notice you required for your current company?

Education:

• Diploma/Advanced Diploma (Preferred)

Work Location: In person