(Contract) QC Inspector

Kymanox•Petersburg, VA

About The Position

Job Description: 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.

Requirements

The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.
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.
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.

Nice To Haves

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.
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

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.