Overview –

The role will ensure that the quality standards of customers are maintained within the facilities that manufacture or assemble customers’ products. The role will continually coordinate with customer quality to maintain and enhance quality in all aspects throughout the manufacturing or assembly process to ensure a consistent product of the highest quality is delivered every shipment.

Responsibilities

• Inspect production process on an on-going basis to identify deviations from quality standards
• Includes manufacturing at final assembly and sub suppliers
• Approve the right products or reject deficiencies
• Deficiencies include anything that fails to meet the product quality requirements
• Submit detailed reports to customers on quality outcomes on a daily/weekly interval
• These reports should include – In-process and release testing completed and supporting data, IQC data, Non-conforming materials and paperwork verifications
• Monitor sub-suppliers to ensure consistent output of approved components
• Identify and recommend continual improvement activities at the factory
• Assess and report on the effectiveness of changes made that were approved by customers
• Report any changes made that were not approved by customers
• Continually ensure that all customers quality requirements are met
• Incoming component testing
• In-process verifications
• Final product release criteria met
• Approved change implementation
• Analyze data output from manufacturing to identify trends and present recommended improvements to customers
• Failure rates, Component issues, test data
• Notify customers immediately when a significant quality deficiency is recognized
• Defined as any failure of parts that impact daily productivity to a level that may impact customers
• Audit the manufacturing facility and sub-suppliers on a routine basis and provide detailed reports to customers
• Assist in the corrective action program at the manufacturing facility to ensure that appropriate root cause analysis is performed, and appropriate long-term corrective actions are implemented
• Report on the outcomes of this program to customers on a daily/weekly/monthly basis
• Verify the effectiveness of corrective actions on an on-going basis and report those results to customers
• Report on the outcomes of this program to customers on a daily/weekly/monthly basis
• Oversee the investigation and outcome from OOS events
• Ensure the investigations are well documented and findings are appropriate
• Sign off on all testing and release criteria prior to final release and shipment to customers
• Verify all items have been completed as required by customers and any deviations have been approved by customers prior to shipment

Preferred Experience

• Work experience in a highly regulated market such as pharmaceutical or medical device or semiconductor.
• Experience with Quality in a high-volume manufacturing environment
• Work experience in an organization certified to ISO 9001 or ISO 13485 TS 16949
• Proven experience driving continual improvement within an organization
• Experience auditing suppliers to identify deficiencies and recommend improvement activities
• Experience compiling detailed reports and charts for data analysis
• Experience performing root cause analysis on identified problem and coordinating/implementing long-term corrective actions.
• Managing Quality systems
• Managing Supplier Quality

Required Skills

• Fluent in English both written and verbal
• High level of attention to detail
• Strong knowledge of cGMP requirements and relevant industry standard practices is required. Demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems.
• Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment.
• Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project

Background:

Requires a bachelor’s degree, prefer Masters preferably in a life science, engineering or business related field plus a desired 5-10 years of relevant experience.  Experience includes Quality Assurance in a pharmaceutical or other GMP environment.  Experience with international regulatory requirements and international business partners is preferred.

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