Senior Quality Manager

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.
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