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(Contract) QC Inspector

Kymanox
Petersburg, United Statesfull_timeVerifiedPosted 21 Nov 2025

About the role

Is Kymanox the right fit for you?      You want to make a difference and have an impact…     You enjoy having an influence in your day-to-day work…     You are motivated by working alongside a team filled with                  subject matter experts who will help you learn and grow…     You wake up every day and do what you do            … because patients deserve better. If this sounds like you, you’ve come to the right place. We are looking for a meticulous (Contract) QC Inspector to support one of our projects for 1 year based in Petersburg, VA.  Responsibilities:
  • Verify engineering drawings and inspection plans against manufacturing facility inventory, maintain inventory control, and ensure compliance using NIST measuring devices
  • Follow written procedures for testing and legibly and accurately document all test data.
  • Maintaining compliance to appropriate US FDA regulations and ISO 13485 Quality Management System standards by following written procedures.
  • Lead and manage the inspection process (incoming, in-process and final) for medical devices, including developing and maintaining inspection procedures, and ensuring compliance with regulatory and company requirements.
  • Review and approve inspection results and related documentation, including NCRs and corrective actions.
  • Performing investigations for: NCR’s, Preventive and Corrective Actions, Deviations and Complaints
  • Reviewing Device History Records (DHR) and providing test/inspection support to all new process developments. Reviewing lab results and approve product release.
  • Maintain accurate and up-to-date records of inspection results and related documentation.
  • The ability to use manual dexterity to measure, using rulers, calipers, micrometers, and other instruments.
Educational Background:
  • The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.
 Experience:
  • 3-5 years of experience working in manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required. 
  • Demonstrated level of experience in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.  
  • Experience with pre-filled syringes, autoinjectors, co-packaged kits, other drug delivery platforms, and/or other combination product platforms is desired.   
  • Familiarity with risk management tools and applications as well as data analysis tools and applications.  
  • Strong knowledge of medical device regulations and standards, including FDA regulations and ISO 13485 and GMP.
  • Knowledgeable in applications of caliper use, calibration and verification of tools, basic math skills and blueprints/drawings comprehension, SPC, IQ/OQ/PQ and quality principles.
  • Proficiency in using a wide range of measuring tools and equipment.
  • Detail-oriented with excellent organizational and communication skills.
  • Attention to Detail in a fast-paced environment
  • Ability to work independently and as part of a team, and to lead and mentor others.
  • Proficient in Microsoft Office applications, including Word and Excel.
 Desired Aptitude and Skill Set:
  • Detail-oriented 
  • Strong organizational skills and verbal/written communication skills
  • Highly motivated self-starter with a sense of ownership and willingness to learn 
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Ability to form partnerships with internal stakeholders
  • Seasoned soft skills (i.e., high EQ)
  • Technology savvy
 Travel:  Up to 10% travel is possible.    Compensation:    Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.  
 About Kymanox:

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Kymanox

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