QC Inspector (Contract)

I s 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

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20 countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.

To learn more about our company, please visit our website: Life Science Solutions | Kymanox

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.