Quality Systems Auditor

Apex Life Sciences Renton, WA

Apex Life Sciences is looking for a Quality Auditor for an organ bank in Renton, WA! Please see below and apply if interested!

  • Performs all facets of quality audits, including: plan development, initiation, observations/interviews, analysis of results, report compilation/distribution, presentation of results to auditees, approval and verification of corrective/preventive actions, and audit file maintenance.
  • Assists QS management with development of quality audit schedules and ensures audits are completed according to schedule.
  • Reviews elements of CAPA investigations for completeness and accuracy, verifies effectiveness of corrective actions, and works with key stakeholders to ensure related documentation adequately resolves the related issue(s); Serves as a QS technical resource/SME for CATSWeb related activities and provides training as required.
  • Develops, maintains, and analyzes quality metrics for Quality Systems related activities.
  • Evaluates the effectiveness and efficiency of regulated processes throughout the organization using a LEAN approach and makes recommendations for improvement.
  • Leads projects with cross-functional teams and promotes problem resolution methods, such as 8D, to solve problems throughout the organization. Participates on project teams as assigned.
  • Creates and revises Standard Operating Procedures consistent with QSR/GTP, AATB, and ISO requirements.
  • Supports third party audits voluntary accreditation agencies and business partners as needed.

Qualifications:

Required:

  • Bachelor’s Degree from a four year accredited college
  • 2 years tissue banking, blood banking, medical device, clinical trial or pharmaceutical experience; Quality or operations related activities
  • Auditing - Demonstrates understanding of quality auditing concepts
  • Analytical Thinking - Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
  • Industry regulations, standards, and guidelines - Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicable
  • Communication - Demonstrates excellent verbal and written communication skills
  • Problem Resolution - Demonstrates ability to anticipate and critically think through problems
  • Technical Writing - Able to create and revise documents, presentations and training materials according to established requirements

Preferred:

  • Bachelor of Science degree in Business Management, Public Health, Quality Engineering, Natural Sciences or Allied Health field
  • American Society for Quality (ASQ) Certification
  • American Association of Tissue Banks (AATB) Certified Tissue Banking Specialist
  • 2 years professional work experience in quality or operational auditing
  • Auditing - Ability to effectively apply auditing concepts to both familiar and unfamiliar areas of focus
  • Analytical Thinking - Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
  • Industry regulations, standards, and guidelines - Familiarity with applicable tissue banking/medical device related regulations, standards and guidelines 21 CFR 1271, 21 CFR 820, ISO 13485, AATB Standards
  • Communication - Ability to effectively communicate with a variety of internal and external customers
  • Problem Resolution - Proficient with advanced problem resolution tools 8D, Ishikawa
  • Technical Writing - Proficiency with word processing, publishing and other relevant software types Microsoft Office, Adobe Pro

Contact: Daniel | [Click Here to Email Your Resumé]

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.