Project Quality Assurance Specialist

1 week ago

Scottsdale, Arizona, United States CND Life Sciences Full time
Job Overview

CND Life Sciences is seeking a highly skilled Project Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for providing project support to all scoped projects impacting quality assurance, continuous improvement, and compliance of Laboratory Operations.

The successful candidate will establish strategies for quality engineering, inspection & testing, suppliers, and supply chain activities, including LIMS, to achieve operational excellence. You will collaborate with cross-functional representatives to develop validation strategies and industry best practices in the implementation of manufacturing operations in a clinical/CLIA/CAP/LDT laboratory environment.

Key Responsibilities
  • Establish and maintain quality engineering processes and procedures to ensure compliance with regulatory requirements.
  • Develop and implement validation strategies for products, equipment, and processes to ensure quality and reliability.
  • Collaborate with regulatory and quality leadership to 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.
  • Lead the quality processes within enterprise-wide projects to ensure validation and regulatory requirements are met.
  • Develop and maintain quality metrics and monitor laboratory processes to identify potential failure modes, risks, controls, and opportunities for improvement.
Requirements
  • 7+ years of experience in Quality Assurance or a related functional area, preferably in the IVD or medical device manufacturing environment or CLIA/CAP/LDT laboratory operations.
  • Development and implementation of production and process controls, including PDCA and 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.
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.

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