Project Quality Engineer

6 days ago

Scottsdale, United States CND Life Sciences Full time
Job DescriptionJob Description

The Project Quality Engineer provides project support to all scoped projects impacting quality assurance, continuous improvement and compliance of Laboratory Operations. Furthermore, this role focuses on establishing strategies for quality engineering, inspection & testing, suppliers and supply chain activities (including LIMS) and validations to achieve operational excellence.

The Project Quality Engineer will collaborate with cross functional representatives such as Laboratory Operations, Digital Pathology, Pathology Operations, Supply Chain, Facilities, to develop validation strategies, and industry best practices in the implementation of manufacturing operations in a clinical/CLIA/CAP/LDT) laboratory environment.

Job Responsibilities:

General Duties

  • Serve as the Company's Quality representative on all functional and enterprise-wide projects.
  • Responsible for establishing the validation and ongoing quality assurance of products moving through the R&D pipeline. Meet regularly with key commercial and R&D and Operations leaders to assess product and technology directions and offer recommendations on validation strategies in alignment with regulatory considerations for US and EU.
  • In collaboration with Regulatory and Quality leadership, represent the Company in interactions with regulatory authorities.
  • Work with outside consultancies to establish a roadmap to compliance with the recent FDA LDT ruling and other projects that support the regulatory evolution of the Company.
  • Collaborate regularly with the Company's head of quality on all laboratory quality requirements, quality manual, quality system, and compliance with laboratory-specific agencies including CLIA and CAP. Work together to achieve appropriate ISO certifications.
  • Independently manage and monitor multiple complexes, novel, and/or diverse projects simultaneously, including projects that involve several functional areas without direct supervision. Maintain a "focused urgency" as required by specific events.
  • Work closely with the quality team to maintain all necessary documents in an effective manner.
  • Other duties as assigned.

Sustaining Laboratory Operation Projects

  • Work closely with laboratory/manufacturing operations and other functions to ensure quality performance of product workflows and associated processes.
  • Support process development and process validation for the laboratory operations.
  • Establish process quality metrics and monitor laboratory processes, identifying potential failure modes, risks, controls and opportunities for improvement while leading large scope CAPA.
  • Utilizing statistical analysis and six sigma techniques, drive product / process improvements and set the foundation for operational excellence.
  • Lead the quality processes within enterprise-wide projects (i.e. LIMS) to ensure validation and regulatory requirements are met.
  • Lead the equipment commissioning, qualification and risk management process.

New Product Introduction (NPI)

  • Develop quality engineering processes within the NPI process to promote quality assurance during the technology transfer process.
  • Utilize risk assessments such as Failure Modes and Effects Analysis (FMEA) to identify and address potential product and process risks throughout the development and NPI process.
  • Lead the validation strategy development for products being transferred.

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.
  • Support the development of material specification and incoming inspection process including test method development and test method validation.
  • Lead the risk-based product/process validation strategy for all supply chain projects that impact product, equipment and process.

Knowledge, Skills & Experience:

  • 7+ 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.
  • Experience in executing problem solving techniques related to manufacturing/design technical issues.
  • Proven ability to drive and develop improvement of critical business metrics.
  • Direct responsibility for process development, design transfer or continuous improvement projects within the quality engineering function.
  • Knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or CGMP preferred.
  • Experience in the development of risk management processes preferred.

Education, Certifications & Licensures:

  • B.S. in Engineering, engineering related discipline or equivalent experience.
  • ASQ-CQE, CQA experience preferred.
  • Six Sigma Black Belt Certification preferred.

Special Training:

  • Fulfill the Company's manager training related to the Company's products, scientific foundation, and other areas

Physical Demands:

  • Ability to use copiers, fax machines, and PDF scanners to keep inventory and ordering records. Visual acuity and analytical skill to distinguish sufficient detail.
  • Must possess the ability to sit or stand for long periods.
  • Must possess the ability to perform repetitive motion.
  • May have exposure to biohazardous material in the lab environment.

  • Engineering Project Supervisor

    2 weeks ago

    Scottsdale, Arizona, United States Softworld Inc Full time

    Position: Engineering Project Supervisor & Release CoordinatorLocation: Scottsdale, AZOnsite Requirements:Expertise in Project Leadership - EVM, CAM, etc.Background in Software or Systems EngineeringExceptional Communication SkillsOverview: As an Engineering Project Supervisor at Softworld Inc, you will play a pivotal role in overseeing engineering projects...

  • Project Engineer

    3 months ago

    Scottsdale, United States Pulice Full time

    PRIMARY RESPONSIBILTIES:Lead project meetings to collect and disseminate information pertaining to the project. Responsible for technical specifications/drawings review and resolution. Coordinate the collection and dissemination of technical information between/within the company and the owner. Schedule and monitor program activity to achieve an on-time...

  • Project Engineer

    2 months ago

    Scottsdale, United States Westwood Professional Services Full time

    Overview: Project Engineer - Phoenix, Arizona Westwood Professional Services, Inc. Westwood Professional Services, Inc. is seeking a Project Engineer to join our land development operations in our Phoenix, Arizona office. Westwood has a highly experienced and dynamic team of individuals dedicated to providing high-level professional services to our clients....

  • Engineering Project Supervisor

    1 week ago

    Scottsdale, Arizona, United States GeoLogics Corporation Full time

    Position Title: Engineering Project Lead & Release ManagerLocation: Scottsdale, AZ - On-site or Hybrid/FlexCompensation: $56/hr W2 (no health benefits during contract)Company Overview: GeoLogics Corporation is actively seeking an Engineering Project Lead and Release Manager.Role Overview:In the capacity of Project Lead and Release Manager, you will...

  • Engineering Project Supervisor

    1 week ago

    Scottsdale, Arizona, United States GeoLogics Corporation Full time

    Position Title: Engineering Project Lead & Release ManagerLocation: Scottsdale, AZ (Fully on-site or Hybrid/Flex)Compensation: $56/hr W2 (No health benefits during contract)Company Overview: GeoLogics Corporation is seeking a qualified Engineering Project Lead and Release Manager.Role Overview:In the capacity of Project Lead and Release Manager, you will...

  • Engineering Project Supervisor

    2 weeks ago

    Scottsdale, Arizona, United States GeoLogics Corporation Full time

    Position Title: Engineering Project Lead & Release ManagerLocation: Scottsdale, AZ - Fully on-site or Hybrid/Flex options available.Compensation: $56/hr W2 (no health benefits during contract period)Company Overview: GeoLogics Corporation is actively seeking an Engineering Project Lead and Release Manager to join our team in Scottsdale, AZ.Role Overview:In...

  • Engineering Project Supervisor

    2 weeks ago

    Scottsdale, Arizona, United States GeoLogics Corporation Full time

    Position Title: Engineering Project Lead & Release ManagerLocation: Position is fully on-site or Hybrid/Flex. Must be available on-site as required.Compensation: Maximum Rate: $56/hr W2 (no health benefits during contract)Company Overview: GeoLogics Corporation is seeking an Engineering Project Lead and Release Manager.Role Overview:In the capacity of...

  • Structural Project Engineer

    2 weeks ago

    Scottsdale, Arizona, United States Water Works Engineers Full time

    Join Our Team as a Structural Engineer at Water Works EngineersAbout Water Works Engineers:Water Works Engineers (WWE) is a premier civil and environmental engineering firm dedicated to delivering innovative and sustainable solutions for water infrastructure projects throughout the United States.Since our inception, we have been at the forefront of planning,...

  • Structural Engineer

    7 days ago

    Scottsdale, Arizona, United States T.Y. Lin International Full time

    Job SummaryTYLin International is seeking a highly skilled Bridge Engineer to join our team. As a key technical role in both conventional and alternative delivery bridge projects, this position requires experience in the supervision and execution of design calculations and reports, as well as the preparation of drawings for projects.ResponsibilitiesProject...

  • Sr Principal Quality Engineer

    1 month ago

    Scottsdale, United States West Pharmaceutical Services Full time

    Job Summary : Maintain a safe work environment and ensure compliance with quality objectives and policies. Work with business leads to develop, implement, and maintain programs and enhance solutions for customer base. Provide quality assurance support to all functions with focus on compliance in accordance with ISO 13485, ISO 14791, 21 CFR 820, and...

  • Engineering Project Supervisor

    2 weeks ago

    Scottsdale, Arizona, United States APR Consulting Full time

    Our client operates in the high-tech sector, specializing in the integration of software and hardware systems, innovative research and development, and manufacturing solutions. They deliver top-tier systems, services, and products to the Department of Defense, governmental entities, and commercial clients. We are currently seeking an Engineering Project...

  • Structural Engineer

    7 days ago

    Scottsdale, Arizona, United States VLMK Engineering + Design Full time

    Job DescriptionAbout the Role:VLMK Engineering + Design is seeking a highly skilled Structural Engineer to join our team in Phoenix (Scottsdale). As a Structural Engineer at VLMK, you will have the opportunity to work on a diverse range of projects, from small to large-scale multidisciplinary projects, and analyze and design various types of structures,...

  • Project Management Engineer

    1 week ago

    Scottsdale, Arizona, United States Path Construction Full time

    Path Construction is seeking motivated recent graduates to become part of their dynamic team. As a rapidly growing commercial contractor, they offer a range of opportunities across various sectors. In the role of Project Engineer, you will be responsible for overseeing subcontractors and suppliers, managing contracts, procurement processes, estimating costs,...

  • Lead Engineering Project Manager

    1 week ago

    Scottsdale, Arizona, United States GeoLogics Corporation Full time

    Position Title: Engineering Project Lead & Release ManagerLocation: Scottsdale, AZ - On-site or Hybrid/FlexCompensation: $56/hr W2 (No health benefits during contract)Company Overview: GeoLogics Corporation is seeking a dedicated Engineering Project Lead and Release Manager to join our team in Scottsdale, AZ.Role Overview:In the capacity of Project Lead and...

  • Lead Engineering Project Manager

    2 weeks ago

    Scottsdale, Arizona, United States GeoLogics Corporation Full time

    Position Title: Engineering Project Lead & Release ManagerLocation: Scottsdale, AZ - On-site or Hybrid/FlexCompensation: $56/hr W2 (No health benefits during contract)Company Overview: GeoLogics Corporation is actively seeking an Engineering Project Lead and Release Manager.Role Overview:In this pivotal role, you will collaborate with a multifaceted...

  • Project Engineer

    4 weeks ago

    Scottsdale, United States Path Construction Full time

    Job DescriptionJob DescriptionPath Construction is seeking qualified college graduates to join our organization in the Scottsdale, AZ area. We are a rapidly growing commercial general contractor with offices in Arlington Heights, IL; Charlotte, NC; Knoxville, TN; Tamp, FL; Dallas, TX; and Scottsdale, AZ working on projects throughout the United States....

  • Project Engineer

    3 months ago

    Scottsdale, United States Path Construction Full time

    Job DescriptionJob DescriptionPath Construction is seeking qualified college graduates to join our organization in the Scottsdale, AZ area. We are a rapidly growing commercial general contractor with offices in Arlington Heights, IL; Charlotte, NC; Knoxville, TN; Tamp, FL; Dallas, TX; and Scottsdale, AZ working on projects throughout the United States....

  • Project Engineer

    3 months ago

    Scottsdale, United States Path Construction Full time

    Path Construction is seeking qualified college graduates to join our organization in the Scottsdale, AZ area. We are a rapidly growing commercial general contractor with offices in Arlington Heights, IL; Charlotte, NC; Knoxville, TN; Tamp, FL; Dallas, TX; and Scottsdale, AZ working on projects throughout the United States. Typical duties of a Project...

  • Senior Principal Quality Assurance Engineer

    2 weeks ago

    Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job Overview Ensure a secure working environment while adhering to quality standards and policies. Collaborate with business leaders to design, implement, and sustain programs that enhance solutions for the customer base. Deliver quality assurance support across all functions, emphasizing compliance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745...

  • Senior Principal Quality Assurance Engineer

    1 week ago

    Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job OverviewEnsure a secure working environment while upholding quality standards and regulations. Collaborate with business leaders to design, implement, and sustain programs that enhance solutions for our clientele. Provide quality assurance support across all departments, focusing on compliance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR)...