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..

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, fumes and bio-hazardous material in the lab environment.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires periodic travel and some evenings, weekends and/or Holidays.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.