Deskripsi Pekerjaan
Are you a seasoned Quality Assurance professional looking to make a significant impact in the high-tech manufacturing sector? Talent Trader Group is seeking a dedicated QA Manager to oversee quality control systems for our clients in the Medical Device and Automotive industries. This is an exceptional opportunity to lead quality initiatives, ensure regulatory compliance, and drive process excellence in a dynamic environment.
In this pivotal role, you will be responsible for establishing and maintaining rigorous quality standards that meet both local and international regulatory requirements. You will act as a strategic partner to production and R&D teams, implementing robust Quality Management Systems (QMS) that minimize risk and maximize product integrity. If you are driven by the challenge of ensuring safety and compliance in critical manufacturing processes, we want to hear from you.
Tanggung Jawab
- Lead Quality Strategy: Develop and execute comprehensive QA strategies for Medical Device and Automotive manufacturing lines to ensure product excellence.
- Regulatory Compliance: Ensure all products and processes comply with relevant standards, including ISO 13485 for medical devices and IATF 16949 for automotive.
- Root Cause Analysis: Lead investigations into defects and non-conformances, implementing effective Corrective and Preventive Actions (CAPA).
- Audit Management: Manage internal audits and prepare for external regulatory audits, driving continuous improvement initiatives.
- Process Improvement: Collaborate with cross-functional teams to optimize manufacturing workflows and reduce waste.
- Training & Development: Mentor QA teams and conduct training sessions to foster a culture of quality awareness across the organization.
- Vendor Management: Evaluate and monitor suppliers to ensure raw materials meet strict quality specifications.
Kualifikasi
- Education: Bachelor’s degree in Engineering, Quality Management, or a related technical field.
- Experience: Minimum of 5-8 years of experience in QA roles, with specific experience in Medical Device or Automotive manufacturing sectors.
- Technical Knowledge: In-depth knowledge of QMS, GMP (Good Manufacturing Practices), and ISO standards (ISO 13485, IATF 16949).
- Tools: Proficiency in quality tools such as Jira, SAP, Six Sigma methodologies, or statistical process control (SPC).
- Leadership: Strong leadership, communication, and problem-solving skills with the ability to lead diverse teams effectively.
- Regulatory: Familiarity with regulatory bodies such as MDA (Medical Device Authority) or FDA regulations is highly desirable.
- Language: Proficiency in English and Malay is required.