Director Of Quality Assurance

  • Job Reference: 381671582-2
  • Date Posted: 27 September 2021
  • Recruiter: Codex DNA
  • Location: San Diego, California
  • Salary: On Application
  • Sector: Executive Positions
  • Job Type: Permanent

Job Description

Summary of Role:

This is an opportunity to be part of a re-focused QA function with an emphasis on adding value to the Company. The successful candidate will manage and implement Codex DNA Quality Program strategy and tactics for new and redesigned reagents and automation platforms across the business to supports growth and compliance readiness. The ideal candidate will have proven leadership capabilities in a Quality Systems role, be pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy. Must also be an effective communicator with ability to collaborate and form strong partnerships within teams and stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives. This position will manage the Codex DNA Quality Assurance program including maintaining, and continuously improving the quality management system, identifying process improvement opportunities and leading problem solving efforts, including Kaizen activities throughout the product life cycle. The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning and organizational skills.

Essential Duties and Responsibilities:

  • Lead the management and improvement of Codex DNA quality program addressing, process, hardware, software and reagents. Ensure compliance and inspection readiness of the Quality System and manufacturing. Develop new processes, as appropriate, to advance the maturity and capability of the quality management system
  • Identify, implement and sustain the Quality Management System for design and contract manufacturing of complex automation platforms. Continuously improve design and qualification processes, in partnership with Engineering, RD, and Program Management to ensure that quality and technical risk management principles are employed early in product life cycles
  • Manage and continuously improve the infrastructure required to perform the core activities of the Quality Management System, including complaints and deviations, Corrective & Preventative Actions (CAPAs), investigations, change control, validations, internal and external audit/inspections, supplier management program and customer inquiries
  • Provides subject matter expertise in quality engineering such as: risk management and risk assessments, design verification, equipment qualification, process validation, design transfer, configuration management, and change control
  • Collaborate across function, leveraging quality and manufacturing expertise to troubleshoot problems, interpret data, and determine next steps.Solves problems using established analysis techniques such as FMEAs, Fishbone Diagrams, 5 Why's analysis, or other standard problem-solving tools consistent with a six-sigma mindset as needed.
  • Manage Quality activities for receiving inspection and test, manufacturing process control, nonconforming material, review of design history files and final product release. Discuss inspection results with those responsible for products; and recommend necessary corrective actions.
  • Works closely with Supply Chain to maintain the ASL and establish supplier quality requirements, quality metrics and corrective actions for all external suppliers Interface with suppliers supporting design and manufacturing activities, manage supplier qualifications related to design and manufacturing activities and SCARs related to these suppliers
  • Promotes quality achievement and performance improvement throughout the organization. Reviews Product Realization metrics and shares analysis with the organization to drive attainment of quality objectives
  • Lead preparations for internal and external Quality Management Systems audits, including regulatory bodies and clients
  • Lead product risk management system; plans, hazard analysis and FMEA in compliance with the requirements of ISO14971
  • Provide training or mentoring to other leaders and teams to elevate efficiencies and facilitate compliance to the Product Development and Design Change Processes
  • Deploys excellent project management skills to develop quality objectives, manage overall quality plans, corrective and preventative actions, process improvement, and auditing timelines.

Overall Quality System Support:

  • Implement and manage the calibration and preventive maintenance program
  • Implement and manage management reviews
  • Develop and implement training program and identify relevant quality-related training needs and devise a training plan to support comprehension and consistent application
  • Manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs Perform internal and external audits
  • Lead change control activities for instrument and reagents manufacturing processes
  • Draft, revise and obsolete SOPs
  • Participate in theproduct review: reviews documents related to products; compiles trend-analysis data and assists in the writing of trend-analysis reports
  • Review and approve qualification, and validation protocols and reports
  • Perform quality assessments for Change Controls
  • Quality Metrics: Collecting, processing and reporting of quality metrics data


Required Qualifications:

  • 8-10 years of experience in progressive roles with manufacturing companies producing reagents and electro-mechanical products, with at least five years in a quality management role
  • 5+ years of relevant experience in ISO-13485:2016 and FDA QSR 21 CFR 820 FDA required. Preference will be given to candidates with experience with ISO 13485:2016 implementation
  • Excellent planning, organizational and communications skills. Experience in leading teams in the implementation of quality improvements systems resulting in reduced cost and cycle times with improved quality of products and services
  • Must have Design Controls experience for both instruments and reagents
  • Experience in world class Quality practices including LEAN Leadership methodologies, root cause analysis, preventative action deployment and quality function tools
  • Effective presentation skills to communicate to all levels on issues that include Quality Plans and Quality Management Systems, performance metrics and improvement systems
  • Excellent ability to navigate fluidly from strategic to tactical work, highly developed multi-tasking and prioritization skills, results-oriented with a strong self-motivation to move quickly to address opportunities thoroughly, while meeting tight deadlines

Education Requirements

  • Bachelor's degree from four-year College or university in an applied science or engineering field is required - Master's degree preferred
  • ASQ Manager of Quality/Organization Excellence certification (CMQ/OE) preferred
  • Certification as an ISO auditor a plus Experience:

Working Conditions:

  • This position is based in our San Diego, CA office, and requires the ability to report to the office daily
  • Prolonged periods of sitting at a desk and working on a computer
  • Ability to lift up to 15 pounds required

Travel Required:

  • 0-25%