• Job Description

  Req#: R2605781
  Employer Industry: Medical Device and Pharmaceutical Manufacturing
  
  Why consider this job opportunity:
  - Salary up to $119,000 annually
  - Bonus and/or incentive eligibility
  - Comprehensive benefits package including health insurance, life and disability, and 401(k) contributions
  - Opportunity for career advancement within a growing worldwide organization
  - Supportive work environment promoting diversity and inclusion
  - Travel opportunities for audits both domestically and internationally
  
  What to Expect (Job Responsibilities):
  - Plan, schedule, and execute complex supplier audits to evaluate QMS and regulatory compliance
  - Manage quality initiatives, evaluate internal processes, and suggest improvements
  - Conduct internal audits in accordance with applicable FDA regulations and ISO standards
  - Write audit reports and communicate results to upper management
  - Provide training and consulting services to internal departments to comply with Quality Management System requirements
  
  What is Required (Qualifications):
  - Bachelor’s degree in microbiology, chemistry, engineering, or a related field
  - At least 2 years of experience auditing FDA-regulated medical device or pharmaceuticals manufacturing or testing, or at least 3 years in a quality role within medical device or pharmaceutical manufacturing
  - Detail-oriented with excellent oral and written communication skills
  - Ability to manage concurrent projects and meet critical deadlines
  - Willingness to travel up to 50% of the time for business purposes
  
  How to Stand Out (Preferred Qualifications):
  - Experience with FDA regulations (21 CFR 820, 21 CFR 210/211)
  - Knowledge of ISO 13485
  - Familiarity with process validation, method validation, and sterilization processes
  - Experience in CAPA (Corrective and Preventive Actions) management
  
  #MedicalDevice #Pharmaceuticals #QualityAssurance #CareerGrowth #DiversityAndInclusion
  
  "We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
  We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."

• About the company

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