Your Job
- Responsible for implementing, improving, and maintaining the effectiveness of the PMTH Quality Management System, including ISO 9001, ISO 13485, FDA, UL/CSA, and other relevant standards.
- Responsible for the control and maintenance of PMTH documentation and records, including MyQMS.
- Responsible for preparing and reporting quality performance metrics such as TCOQ, COPQ, QNs, and CAPAs.
Our Team
You will be reporting to Quality Systems & Regulatory Manager
What You Will Do
- Implement and maintain the effectiveness of Quality Assurance systems to ensure full compliance with QMS standards and local requirements, including ISO 9001, ISO 13485, and FDA regulations when need
- Ensure that all SOPs are established, updated, and aligned with global MPS documents, while meeting business and local regulatory needs.
- Monitor PMTH manufacturing activities, post market information, and changes in ISO standards and FDA regulations; conduct impact assessments and coordinate updates to PMTH policies.
- Manage internal audits, customer audits, certified body audits, and FDA regulatory audits.
- Develop the PMTH internal auditor team to improve audit capability and effectiveness.
- Coordinate the handling of audit discrepancies, observations, and notifications; ensure corrective and preventive actions (CAPA) are effectively implemented.
- Coordinate with Phillips-Medisize regional and global teams to maintain QMS effectiveness.
- Implement and maintain the effectiveness of MyQMS and enhance users knowledge and utilization of the system.
- Report key quality performance and KPIsincluding TCOQ, COPQ, QNs, and CAPAand coordinate corrective actions to keep quality performance and KPIs on track.
- Manage UL/CSA compliance and coordinate with UL/CSA inspectors to ensure all required standards are met.
- Promote QMS management principles, GMP/GDP, and a culture of quality; support continuous improvement of PMTH Quality Assurance Systems.
- Perform other duties as assigned by the supervisor.
Who You Are (Basic Qualifications)
- Bachelor's degree in engineering or an applicable discipline.
- Minimum of 2 years of work experience in managing the quality system, preferably with ISO 13485 and FDA CFR 820. Experienced with manufacturing environment is an advantage.
- Fluency in both Thai & English.
What Will Put You Ahead
- Knowledge of ISO 9001 and ISO 13485 requirements and auditing.
- Computer literacy.
- Good interpersonal skills.
- Good command of English.
- Experience with SAP.
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At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
As a Koch company, Molex is a leading supplier of connectors and interconnect components, driving innovation in electronics and supporting industries from automotive to health care and consumer to data communications. The thousands of innovators who work for Molex have made us a global electronics leader. Our experienced people, groundbreaking products and leading-edge technologies help us deliver a wider array of solutions to more markets than ever before.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy [link removed] helps employees unleash their potential while creating value for themselves and the company.
