Quality Control Inspector I

Duration: 12+ Months

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• 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.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• High School diploma (or GED) and some college level courses

• 2-7 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.

Shift:

2nd shift - Second Shift – 3:00PM – 11:30PM