QA Manager - Singapore - Venture Corporation Limited

Venture Corporation Limited

Verified Company

Singapore

2 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

JOB RESPONSIBILITIES / AUTHORIZATION LEVEL

Support TCS Director by providing all the necessary Quality function support for the customers in the TCS. Responsible to coordinate the dedicated quality resource, and to step in as required to fill in temporary gaps, and be the point of escalation for customer quality counterparts.
Ensure the customer feedback are rapidly reviewed and effective containment actions, including Quality Alert, screening, and if required purge and stop shipment/production, are taken.
Bridge to ensure material issues detected by customers are reviewed against internal production material performance, and ensure SQE and CQE jointly take rapid actions (including Purge, Stop Shipment/Production) to contain the material problem and to address to suppliers.
Manage and support CQEs on timely and effective NC / SCAR investigation and review/ approve the reports.
Guide Supplier Quality Engineers in supplier investigation to Material NC Issues through the NCMR FA and SCAR systems, and to review and approve SCAR reports for adequate actions by suppliers.
Drive for Quality Improvement for TCS selected problematic suppliers, targeting effective containment actions (supplier inprocess and outgoing QC, as well as GES incoming) on top defects, while addressing the longerterm fixes. Participate in supplier audits with respective SQE to understand supplier process controls.
Early involvement with R&D to understand product and part issues. Engage SQE team for timely and effective review of FAQ package, follow up with R&D to close NPI Open Issues (update drawing or supplier resolve dimensional issues) for lots released under DA.
Manage RMA team on timely turnaround of units, sending of NC parts for supplier FA.
Manage Quality Inspectors effectiveness and efficiency, through regular review of control plan and quality checklists against quality feedbacks and product PFMEA.
Regularly conduct comprehensive data analysis and action plan for RC categories of issues related to Workmanship and Material, and drive for effective countermeasures from internal stakeholders, to improve product quality performance.
Adopt a growth and learner mindset to continually build up respective product knowledge including functionality, assembly process, test process, critical parts, cosmetic and functional requirements, and failure modes, effects and existing controls; and encourage the knowledge and skill development of the team.
With stable Product Quality established, Quality Manager shall pursue productivity improvement initiatives including digitalisation and automation, by engaging resources such as AMTC (Advanced Manufacturing Technology Center, AMK), MIS (Management of Infomation System) and external IHL (Institute of Higher Learning).
Review various requests, including Deviation Authorization, RoHS, Documentation, and Engineering Change, for adequacy before approval.
Manage the quality requirements for the respective TCS customers' Change Management. These changes could originate from GES suppliers, customer or internal.
Responsible for the TCS customer specific quality documentation procedures, forms and record, to maintain and revise for adequacy and efficiency.
Engage with System Quality team to prepare and coordinate customer audits.
Responsible for the TCS customer specific quality agreement, to promote the awareness and compliance.
Coordinate and drive Sustainability initiatives for customer impact

EDUCATION and EXPERIENCE

Good Degree in Engineering;
Technically inclined with handson Product Quality experience
Minimum 3 years of Managerial experience in Quality Assurance
Experience in IVD Medical Devices Manufacturing environment

JOB-RELATED SKILLS

Working knowledge of ISO13485 and FDA 21 CFR Part 820 & Part 11, cGMP
Effective communication skill to engage multiple stakeholders, internal and external
Effective teambuilder, able to motivate and harness potential
Working knowledge of SAP Material Master (MM) and Quality Module (QM) will be advantageous
Working knowledge of CAPA system, Validation system and DHR system