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Position Summary
+ Staff Operations Quality Engineer provides quality assurance support for all aspects of manufacturing operations, including process quality, quality control, testing, inspections (incoming, in-process and final), supplier quality and various QMS activities through the operations lifecycle. Furthermore, this role focuses on establishing strategies for quality engineering, inspection & testing, suppliers and supply chain activities (including Oracle ERP ) to optimize operational efficiency and achieve excellence.
+ The role collaborates and build relationships with cross-functional stakeholders such as Laboratory Operations, Supply Chain, Supplier Quality, Equipment, Facilities, EH&S, Quality Assurance, Quality Control and QMS teams to develop ideas, information, use cases, and industry best practices in the implementation of manufacturing operations in a hybrid (diagnostic/ IVD and clinical/ CLIA / CAP / LDT ) laboratory environment.
Job Responsibilities
Process Controls/Quality
+ Work closely with laboratory/manufacturing operations and other functions to ensure quality performance of product workflows and associated processes.
+ Support process development and process characterization for the laboratory/manufacturing operations. Capture process knowledge to facilitate subsequent process validation activities.
+ Process Monitoring: Support process monitoring to ensure ongoing product quality, effectiveness and compliance using established statistical methods.
+ Process Improvement: Continuously monitor and analyze production processes, identifying potential failure modes, risks, and controls, and opportunities for improvement and implementing corrective and preventive actions.
+ Employ statistical analysis, and problem-solving techniques to drive product quality improvements, minimize defects, and enhance overall performance.
Production Controls (Manufacturing Quality)
+ Ensure the efficient and timely transfer of Process knowledge and Quality systems knowledge to Laboratory (Manufacturing) Operations.
+ Support the creation of production documents such as DMR (Device Master Record) and quality records such as DHR (Device History Record or batch records) for new medical device/ IVD products.
+ Coordinate the training of Laboratory Ops personnel, Quality Engineers and related personnel on various manufacturing procedures, quality systems, equipment etc.
+ Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential non-conforming product.
NPI /Manufacturing Transfer
+ Provide quality engineering support for the execution of quality assurance activities during new product introduction.
+ Develop quality assurance practices for NPI , and/or Manufacturing Transfers.
+ Risk Assessment: Conduct thorough risk assessments, utilizing tools such as FMEA (Failure Modes and Effects Analysis), to proactively identify and address potential product or process risks.
Inspection and Testing: Incoming, in-process and final
+ Support the development of material specification and incoming inspection process including test method development and test method validation.
+ Oversee incoming inventory material receiving records, and quality control testing documentation to release the materials for production use.
+ MRB (Material Review Board): Lead MRB activities including investigations of non-conforming products and materials to identify root causes and determine appropriate disposition. Lead complaints investigation related to products through MRB .
+ Final inspection/release: Review, sign-off and release of kit, batch and other manufacturing records to ensure the completeness of DHR (Device History Record).
Quality Control
+ Provide ongoing quality engineering support for reagent quality control testing and product release throughout the product life cycle.
Supplier Quality
+ Oversee supplier quality initiatives, including supplier selection, monitoring of supplier performance, conducting audits, and ensuring effective corrective actions to maintain a robust supplier quality program.
Change Controls
+ Lead change control activities throughout product life cycle, including in-house and supplier-facing design and manufacturing changes.
Regulatory Compliance
+ Drive a customer (internal and external) centric quality culture and maintain compliance to applicable standards, regulations and internal QMS requirements.
+ Support audit preparation strategy and execution. Participate and interface with internal & external audits with the QA team.
+ Support various QMS process including but not limited to NCs, CAPAs, deviations, and complaints root-cause investigations.
+ Ensure adherence to GMP , EH&S and other applicable procedures to manufacturing.
+ Maintain quality metrics and ensure proper documentation and reporting in compliance with the regulatory requirements.
Inter-Organization Collaboration
+ Build productive and collaborative internal/external professional relationships across various teams and functions associated with laboratory/manufacturing operations, supply chain, supplier quality, equipment, facilities, EH&S, quality assurance and quality control activities.
Other
+ ERP : Support the implementation, testing and maintenance of the new ERP system (Oracle). For various QMS related activities performed within ERP /Oracle , implement interfaces to eQMS including pertaining procedures, training of personnel and support of validation activities.
+ Provide mentorship and guidance to other operations quality team members, fostering a culture of growth and expertise within the department.
+ Other duties and responsibilities as assigned.
Required Qualifications
+ B.S. in Engineering, engineering related discipline or equivalent experience.
+ 5+ years in Quality Assurance or related functional area preferably in the IVD or medical device manufacturing environment or CLIA / CAP / LDT /clinical laboratory operations.
+ Development and implementation of production and process controls (i.e. PDCA , DMAIC experience).
+ Demonstrated knowledge of improvement and statistical tools/techniques used within process excellence activities.
+ Expert knowledge of process monitoring, quality assurance, quality engineering and quality control methodologies.
+ Experience in executing problem solving techniques related to manufacturing/design technical issues.
+ Proven ability to drive and develop improvement of critical business metrics.
+ Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.
Preferred Qualifications
+ ASQ - CQE , CQA experience desired.
+ Six Sigma Black Belt Certification preferred.
+ Knowledge of regulations pertaining to, or experience working in, clinical/ CLIA / CAP / LDT and/or diagnostic/ FDA / IVD labs is a plus.
+ Experience working within FDA regulated environment, preferably in the IVD or medical device manufacturing space.
+ Knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or CGMP is a plus.
+ Experience participating and providing support during regulatory inspections.
+ Experience in risk management techniques.
+ Our ideal candidate will embrace working in a fast-paced, entrepreneurial, and collaborative environment; be a self-starter, independent, results-oriented team player with a demonstrated ability to manage multiple projects and deadlines including shifting priorities.
Physical Demands
+ Employee may be required to lift routine office supplies and use standard office equipment.
+ Ability to sit for extended periods of time.
+ Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center
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