Main role:

Responsible for development, implementation and maintenance of the Quality Management System (QMS).

The Senior/Quality Manager is the Quality figurehead for the site and as such will drive a culture of compliance, responsiveness and data-driven decision making. The role will ensure the quality team is structured appropriately and will provide direction to the individuals reporting to him/her.

JOB REQUIREMENT / RESPONSIBILITIES

Quality Compliance

• Ensure that the processes and documentation needed for the Quality Management System (QMS) are established, implemented and maintained per the following standards/regulations ISO 13485 and FDA 21 CFR 820 for medical business, IATF 16949 for automotive business and ISO 9001 for technology business.
• Manage, plan and perform internal and external quality audits to ensure compliance to the standards, regulations and documented quality management system.
• Report to executive management on the performance of QMS regularly.
• Ensure appropriate management of the sites Quality System (CAPA, Deviations, Nonconformance, Document Control, Supplier Quality Management, Complaints, Audits etc).
• Promote awareness of regulatory and customer requirements throughout the organisation and ensure employee compliance to those requirements.
• Host regulatory agency and customer quality audits.
• Work with suppliers of both raw materials and services, to improve product quality and/or resolve quality issues. This includes suppliers' quality monitoring and auditing at suppliers' sites if needed.
• Review and approve all suppliers of components, raw materials, products and services which forms part of the final product, and which directly affect the product quality. Assist in the assessment / certification of critical suppliers.
• Develop site-wide Good Manufacturing Practice and related training programs appropriate for all levels of staff to increase the awareness of quality and improve quality standards.
• Ensure that the site comply with ISO 14001 (Environmental Management Systems) and other regulations.

Quality Operations

• Ensure timely release of finished products upon completion of testing and inspection.
• Ensure quality participation in planning and execution of new products introductions including advising on validation and qualification strategy etc.
• Utilize formal problem-solving techniques to resolve product and/or process related issues by implementing sustained improvements.
• Utilize data to drive decision making, ability to drive value add quality initiatives and focus on Performance / Metrics data for preventative and corrective action measures.
• Drive and implement continuous improvements in quality area and participate in related cross functional projects.
• Ensure quality records are complete and accurate as well as quality control operations are effective and efficient.
• Provide oversight of discrepancies or non-conforming product/material and drives timely disposition. Lead investigation and collaborate with process owners and/or subject matter experts to align on disposition/release criteria.
• Serve as the quality point of contact for customer audits, complaints and product quality issues.
• Ensure all corrective and preventive actions are developed and effective to resolve the nonconformances found.
• As required, lead cross-functional teams to support resolution of product and/or process quality related issues to meet plant quality goals/objectives.
• Provide leadership and direction to the plant in relation to all QA matters, including quality systems and compliance, material disposition.
• Adhere and comply with Safety and Environmental standard and policy
• Any other jobs/tasks assigned.

EDUCATION / ACADEMIC QUALIFICATION

• Bachelor of Science or Engineering Degree (eg. Biomedical, Mechanical, Mechatronics, Chemical, Polymer, Industrial, Quality Management)

KEY REQUIRED EXPERIENCE, SKILLS AND ABILITY

• Minimum 10 years of progressive responsibilities in quality assurance and control in manufacturing or equivalent.
• Robust and thorough knowledge and understanding of ISO 13485, FDA 21 CFR Part 820, and/or the Medical Device Directives for medical business and ISO 16949 for automotive business.
• Strong knowledge of GMP requirements in a regulated manufacturing environment.
• Strong understanding of injection molding process and tooling.
• Computer literate in Microsoft Office applications.
• Demonstrated proficiency utilizing engineering tools (i.e. FMEA, MSA, DOE, SPC, statistical tools, etc.).
• Demonstrated knowledge and proficiency in process analysis, problem solving skills and improvement using process flow and Lean Manufacturing methods.
• Ability to perform activities to support product development, manufacturing, and product release as identified by Senior Management.