Staff Operations Quality Engineer

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