Senior Quality Engineer

NeoGenomics Laboratories in Aliso Viejo, CA

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
  • Compensation: $103,730.00 - 157,700.00 / Year*
position filled
The Sr. Quality Engineer is a key contributor to the Quality team in implementing and maintaining and effective Quality Management System (QMS). This position collaborates with the Manager of QMS to maintain a constant state of regulatory compliance and ensuring customer satisfaction by providing outstanding quality services. Specifically, this position improves and maintains the company s CAPA and Complaint processes as well as executing equipment and process validations in the operations environment.

Responsibilities:
  • The Quality Engineer will be responsible for the investigation of complex quality and compliance issues (e.g., CAPA, Nonconformance, audit observations) for both Clinical and Pharma divisions
  • Lead Production and process controls CAPA projects and serve as a technical review of validation deliverables
  • Manage the validation deliverables of CAPA projects ensuring new equipment and systems are implemented within predetermined timelines, escalating any potential misses and develop remediation plans when possible.
  • Lead cross functional teams/initiatives to drive validation activities, change control and improvement projects, including projects aimed at improving TAT performance, projects to improve yield, reduce cost, or lower our processing cycle times.
  • Represent Quality/Validation needs on multifunctional project core teams
  • Responsible for developing validation strategy and coordinating validation activities required to complete large scale validation projects according to the NeoGenomics quality and safety policies, SOPs, and FDA regulations.
  • Responsible for performing product, process and equipment validations/qualification and other quality related activities with minimal guidance and supervision
  • Employ risk analysis tools to determine appropriate corrections required
  • Develop and employ sound investigative techniques to fully understand and document problems
  • Will support and maybe the lead quality engineer for medical device design and development activities
  • Utilize, lead, and facilitate formal Root Cause analysis/techniques
  • Thoroughly document all aspects of the CAPA process to develop an audit ready CAPA record
  • Interface with cross-functional teams throughout CAPA process to ensure effective outcomes
  • Determine training needs for changes implemented through the CAPA process
  • Collaborate with Management to establish and meet CAPA targets and timelines
Qualifications:
  • Bachelor s Degree, preferably in the Life Sciences, Engineering or an equivalent field of study.
  • ASQ CQE and Six Sigma/Lean Six Sigma, preferred.
  • Travel will be less than 25%. Some overnight travel may be required.
  • 5-10+ years experience of relevant Diagnostic Laboratory, pharmaceutical, medical device or experience in a Quality Assurance position. (FDA 21CFR Part 820, ISO13485, CAP/CLIA).
    • Strong knowledge of QMS in a regulated environment
    • Minimum of 2 years of experience performing CAPA investigations, documentation and performing effectiveness verifications of CAPAs.
    • Experience in FDA regulated industry required, specifically knowledge of applicable regulations, i.e. current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
    • Strong CAPA Root Cause Investigations to lead and train the organization
    • Strong QMS experience in relation to the below elements
      • Production & Process Controls (Validations, Calibrations)
      • Technical analysis/Sampling plans
    • Strong computer skills, i.e., word processing, spreadsheets, data analysis, etc.
    • Must exhibit strong and effective communication skills to develop and write technical presentations and documentation
    • Must have excellent and effective writing skills.
    • Must be able to maintain a high activity level, and be able to effectively manage and prioritize numerous projects and responsibilities.
    • Ability to work under deadline pressure and extra hours if needed on assignments.
    • Detail-oriented, proven problem solver and analytical thinker with exceptional organization skills.
    • Ability to work independently, displaying good judgment and decision making.
    • Demonstrated skills to handle a variety of assignments simultaneously.
    • Demonstrated skills in training, validation, written/oral communication, and computer skills to support the Quality Improvement activities preferred.
    • Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.

Associated topics: bioengineering, biological engineer, biology, biomedical engineer, biophysics, medical, metabolic, msat, nutrition, pharmaceutical

* Estimated salary


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