Assistant Quality Manager

Position Summary

Principal Responsibilities

1.    Ensure compliance to the Quality System Regulations (QSR), MDSAP, ISO134585, MDD or EU MDR and other relevant site standard.
2.    Where appropriate, provide relevant Quality support in achieving Site Operational, Financial and continuous improvement goal such as CIPs and Quality Improvement Program.
3.    Quality Management of Operations – control of in-process inspection, sampling, testing, disposition, reporting, record maintenance, headcount management, CIPs, and testing equipment maintenance.
4.    The Assistant QA Manager is front line Quality Leader who lead a team of QA Supervisors and are expected to work well with the employees they supervise. The QA Supervisor should be able to function well without a lot of supervision yet also report important events or problems to the manager they work under.
5.    The Assistant QA Manager understands the expectations of higher management and how to meet or exceed these goals. The QA Supervisor is responsible for getting the most of the goals from the Operations by inspiring and motivating them by communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; initiating, coordinating, and enforcing quality, systems, policies, and procedures. 
6.    To organize and control all Quality inspections activities ensuring smooth running of the production floor so that the desired level of quality as per assigned standard is achieved. An Assistant QA Manager also must work directly alongside QA Operations Manager, QA Engineering and Operations Assistant Manager to accomplish tasks
7.    This role required budgeting skills to plan expenses annually to sustain Quality Operations performance.
8.    This role required to manage QA supervisors at shop floor who are managing the Quality Inspectors in the shop floor.
9.    This role is responsible to ensure high quality products are being manufactured by ensuring all in-process quality related checks performed at specified intervals. This role also required to review and ensuring completeness of all manufacturing batch records prior to release of finished products in market.
10.    Resolves Quality problems by analysing data; investigating issues; identifying solutions; recommending actions.
11.    To follow up in implementation of preventive maintenance of inspection equipment handled by QA.
12.    To develop Quality Inspection & Detection for continuous improvement activities
13.    Having good data analysis skills and able to manage/ prioritize tasks
14.    Maintains workflow by monitoring steps of the process; setting Quality Detection variables; observing Quality & Critical control points and equipment; monitoring personnel and resources allocated is effectively; studying methods; implementing cost reductions; developing reporting procedures and systems; facilitating corrections to malfunctions within Quality control points; initiating and fostering a spirit of cooperation within and between departments. 
15.    To ensure workstations are well keeping all the times and properly maintain premises and work environment safe and clean by ensure the team under supervision is comply with Safety Regulation, Occupational Safety and Health Act 1994 and other legislative requirements.   
16.    Ensure all activities comply with industry standards and regulatory requirements (e.g., FDA, ISO 13485).
17.    To ensure quality initiatives i.e. TPS, 5S Poka-Yoke, TPM, Kaizen and other continuous improvement activities are promoted and carried out in the shift.
18.    Conduct regular audits and inspections.
19.    Ensure accurate and timely documentation of processes, procedures, and incidents.

Education / Experience Requirements

Qualification    
•    Bachelor’s degree in engineering, Life Sciences, or a related field.

Experience    
•    Minimum of 4 years of experience in the medical device or related industries

Other Competencies/Skills    
•    Strong knowledge of USFDA regulations, ISO 13485, and GMP standards.
•    Proven ability to lead and develop a high-performing team
•    Good problem-solving, organizational, and communication skills.
•    Proficiency in relevant software and tools (MS Office), SAP shall be an additional benefit
•    Proven skills of budgeting.

Working conditions    
•    Standard office and manufacturing environment.
•    Ability to work flexible hours as needed.

Specialized Skills / Other Requirements