Quality Assurance Manager

Our client has developed into a multi-national group of companies specialized in microtechnology. Over the past 120 years, it has established its leading position in several specialty markets by continuously pioneering technologies and processes to perform custom micro-assembly operations of the very smallest dimensions. The company's continuous growth is due to its expansion in the market for custom micro-components used in implantable and wearable medical devices.

They are looking for an experienced Quality Assurance Manager for their site in Malacca.

Main Responsibilities:

1. Based on the group guidelines, develop, write, implement, manage and implement the QMS documentation: from the organizational documents (Quality Manual, organizational Procedures), to the operational production/control documents (Control Plan and included documents).
2. Manage the Quality Management System (QMS) according to the company's guidelines and in accordance with ISO 9001 standard (possibly integrating specific customer requirements).
3. Guarantee the adequacy of the production process (production and control), to realize products in conformity to given customer specifications.
4. Support the Headquarters New Product Development Team to ensure a successful transition of products and processes from design to production.
5. Drive quality initiatives designed to obtain and maintain ISO-9001:2015 certification, and other related international certification requirements.
6. Coordinate new production process start-up (process transferring from other group sites and/or new process setting). Acknowledge, understand and implement the Control Plan and all its related documentation requirements.
7. Take a collaborative, hands-on leadership role in training and deployment of Quality System operative tools and methodologies to raise quality awareness and create a company-wide culture of quality.
8. Train operators/technicians, monitoring the process performance (efficiency, scraps rate), especially in the ramp-up phase.
9. Monitor the process performance, especially in the ramp-up phase and present to HQ regular reporting thereof (reject rates, details of significant issues, efficiency, first-time yield by product line, the availability of necessary human, material and equipment resources).
10. Take a leadership role in organizing and centralizing collection of production quality data and statistics in collaboration with Production and Process Engineering.
11. Coordinate the activities launched by Headquarter New Product Development Team, aimed to validate the production process before mass production: new machines validation (test campaign, structured data collection), performing Measurement System Analysis (MSA), process capabilities studies (Cp, Cpk).
12. Manage operatively the Non-Conformities (internal and customer claims) in collaboration with Production and Headquarter Technical Team Specific Training about ISO 9001 standards.
13. Manage the company's internal and external calibration requirements.
14. Prepare and coordinate internal and third-party auditing with consequent follow-up of the possible corrective actions.
15. Support our client group as requested by HQ to ensure effective parallel production in Melaka and other Group production sites.

Key requirements:

1. University/Bachelor's Degree (Engineering, Physical Sciences or any equivalent in Technical discipline).
2. Specific Training about ISO 9001 standards.
3. Experience in micro-electronics, coil winding, micro-coil winding, electro-magnetic is a plus.
4. Effective interpersonal and communication skills.
5. Planning & Organization skills.
6. At least 5-8 years proven Quality Assurance managerial work experience in manufacturing organization performing design production process (automotive or medical is preferred but not necessary).
7. English (mandatory): Fluent in both written and spoken English.
8. Proficiency in Microsoft Office and Windows applications.

#J-18808-Ljbffr