Quality Assurance Inspector

Purpose The Quality Inspector, under general supervision, will perform activities to determine acceptability of product and materials to appropriate standards, guidelines and conformance criteria specified in procedures, work instructions, drawings and products (parts, sub-assemblies and finished) specifications.

Responsibilities

Inspect, measure and test product materials in accordance with specification, drawing, SOP’s and regulatory requirements. Perform and document incoming, in-process and finished product inspection of components, material and products and maintain accurate records of inspection results. Utilize calipers, snap gage, coordinate measuring machine (micro-vu), microscope and other technical measuring devices to determine product conformance to specifications and product requirements.

Must be able to work in clean room environment that requires gowning. Generate Non-conformance Reports (NCRs) for corrective action and disposition of non-conforming products and material. Maintain accurate inventory log of product retains. Perform and document Device History record review and release of sub-assembly and finished products.

File and maintain records in accordance with standard operating procedures. Evaluate product returns in support of complaint investigations, including related issues (for NCR and CAPA) Act as a backup support for departmental needs. Occasionally move or lift up to 25 pounds. Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.

Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures. Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.

Perform other duties as assigned. Skills Ability to read and interpret mechanical drawings and specifications Knowledge of FDA’s Quality System Regulation GMPs Ability to function in an FDA regulated environment. Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.

Ability to communicate effectively, both orally and in writing. Ability to work independently and in a team environment. Highest level of ethics and integrity. Ability to multi-task and work in a fast-paced environment. Proficiency in Microsoft Office and ability to learn various software programs. Qualifications/Requirements High school diploma or equivalent required from an accredited institution.

At least 3 years of work experience in Medical Devices or Pharmaceutical Industry; or equivalent combination of education and experience. Clearance of favorable background investigation required.