Manager I Manufacturing Quality

Education

Bachelor’s degree in Mechanical Engineering or Industrial Engineering, Specialty and or Master Degree

Requirements

Work Experience  

 6 – 12 years of Quality Assurance experience in medical devices manufacturing or high volume of consumable products with medium automation environment. Which at least 1 years in Leadership position covering a large spectrum of QA work.

Knowledge  

•    Familiar with 7 sub-systems of Quality System, 
•    US Food and Drug Administration (FDA), 
•    ISO9001 and or ISO13485 international standard, 
•    Quality tools, e.g., Plan Do Check Act (PDCA), Statistical Process Control (SPC),
•    Measurement System Analysis (MSA),
•    Change Management
•    Root Cause Analysis Methodologies
•    Costumer Complaints Handling
•    Quality Operations
•    Process Validation, Software Validation, 
•    Process Characterization, 
•    Design of Experiments (DOE) and others
•    Process Capability (Cp, Cpk, Ppk)
•    Quality Assurance knowledge
•    Internal Audit and/or Lead auditor certification.
•    Lean Manufacturing Basics.

Skills    

•    Problem solving skills
•    Interpersonal skills
•    Critical Thinking
•    Facilitating and communication skills
•    Focus on Customer and Deliver Results
•    Collaboration and Teamwork
•    Communication with Impact
•    Lead by Empowerment
•    Strategic and Analytical Mindset
•    Creativity and Continuous Improvement
•    Adapt to Changes
•    Take Initiatives to Decide and Act
•    Commit to Regulations and Values
•    Business and Professional Excellence

Others    

• Proficiency in English
• Computer literacy
• Use of statistical analysis software, e.g. minitab

Job Responsibilities

1.    Formulate and implement quality strategies for all phases of manufacturing operation to ensure that all products manufactured meet the quality, safety and regulatory standards. Assess business processes, identifying continuous improvement opportunities for efficiency, scalability, and risk Reduction, for the area assigned. 

2.     Establish and monitor KPI and meet operation targets across business units. Monitors IQC/IPQC/FQA/OQC and FPY activities to ensure that Operational personnel follow through and timely escalating abnormal incidences. Drive internal improvement using 8D / CAPA (Corrective and Preventive Action) improvement system. Work with cross-functional teams to perform FA (failure analysis), investigation and follow up improvement areas across BU.

3.    Plans and manages the assigned resources, KPI and operation budget are within the agreed targets.

4.    Establish the strategies to determine and assign resources to support the New Product introduction (NPI) and sustaining projects in order to complete all the QA readiness and deliverables related to the project.

5    Lead, Coach and facilitate root cause investigation thru 8D CAPA’s, of Customer Complaints, QA incidents, QA events.

6    Approve SOPs, Work Instructions (WI) and qualification documents to support production activities for the area assigned