QA/RA Specialist (Manufacturing)
- Ensure company’s ISO13485 Quality Management System are carried out effectively and maintained in accordance to released quality procedures, work instructions, documentation control system and applicable statutory and regulatory requirements.
- The scope shall cover quality related activities in the instrument, consumables and bio manufacturing
- In charge of the planning, coordination and execution of internal and external audits, work with all party to generate audit reports and audit closure.
- Conduct supplier assessment, qualification and evaluation of supplier’s performance.
- Responsible in conducting incoming, in-process and outgoing quality control and final product release to customer.
- Involve in Customer Feedback committee and follow up with relevant stakeholders in the investigation and closure of issues as according to company’s corrective and preventive action (CAPA) system.
- Responsible for company-wide calibration system and all related activities.
- Ensure risk management to product quality are effectively carried out and comply to SOP
- Lead in part non-conformance activities including conducting material review board meeting, supplier return handling, Supplier Corrective Action Request initiation, tracking and closure.
- Responsible for compiling, reviewing, submitting and following up regulatory submissions and marketing authorisation applications, where required
- Maintain records of regulatory submissions and communications to consultant (if any) and/or relevant regulatory authorities
- Academic Level: Diploma/Bachelor Degree holder or above;
- Field of Study: Mechanical, Electrical & Electronic Engineering, Bioengineering or Equivalent
- Experience: 3-5 years of experiences in manufacturing environment
- Familiar with ISO 13485 standards, local regulatory and compliance standards.
- Strong verbal and written communication skill, ability to work with cross functional department.
- Knowledge in SPC/six sigma/lean manufacturing and other improvement methodologies will be a plus.