Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.
Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.
But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours.
The Quality Inspector will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.
Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
Read and interpret sampling pan as per the American national standard institute (ANSI),
Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
Promote and participate in continuous improvement initiatives.
Responsible for the maintenance of appropriate conditions of all quarantine locations.
Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
Maintain records of inspection and all testing performed on the appropriate test records.
Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
May also perform other related duties, responsibilities, and special projects as assigned.
High School diploma (or GED) and some college level courses
3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
QA experience in the medical device industry preferred.
Must have strong written and verbal communication skills.
Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
Knowledge of CAPA, Validations, Change Control, preferred.
Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
Ability to define problems, collect data, establish facts and draw valid conclusions
Ability to work effectively in a cross functional environment
Ability to integrate quality objectives across multiple functions
Attention to detail, strong time management are essential
Must be able to work independently with minimal supervision.
Integra Lifesciences Holdings Corporation