General Summary:

The Quality Assurance Specialist will support the Quality Assurance Manager carrying out a wide range of Quality related tasks to help ensure the overall Quality System requirements and standards are met including FDA, ISO, OSHA and other applicable regulatory agencies.

Key Responsibilities:

Responsible for supporting day-to-day activities of the Quality Assurance department to ensure FDA, GMP and ISO compliance.
Assisting Team Members to ensure that proper GDP is being utilized.
Responsible for maintaining customer files, as well as batch record files.
Responsible for trending of data.
Responsible for archiving of all quality documents.
Responsible for the disposition of all quality documents as per procedure.
Reviews and prepares Sterilization Batch Records ensuring quality standards and specifications are achieved.
Responsible for reviewing cycle data for compliance to customer’s specifications.
Supports and assists the Quality Assurance Manager with complaint handling, investigations, non-conformances, deviations, corrective/preventive action and reporting.
Supports and assists the Quality Assurance Manager with engineering change notices, FMEA’s, equipment qualifications, as well as the monitoring of the Calibration program.
Responsible for preparation of the shipment of test samples.
Responsible for the Biological Indicator tracking program.
Assists with audit preparations, as needed.
Assists Quality Assurance Manager during Audits, as needed.
Assists in the updates and modifications to ISO/QSR procedures, work instructions and forms.
Assists in the Product Damage Reports process.
Assists General Manager, Quality Assurance Manager, and Team Members with other duties and projects, as assigned.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty/key responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

Bachelor’s degree Biology or related science is preferred, not required. Ongoing training / seminars in Quality Assurance / Medical Device desired.

Experience:

3+ years of related Quality Assurance experience in a similar environment preferred. Prior Quality experience in Sterilization, Ethylene Oxide (EO) and / or a Medical Device facility is highly preferred.

Skills & Abilities:

Must have a sound understanding of FDA, QSR and ISO regulations as well, as basic Quality Assurance principles required. Detailed oriented, organizational skills, precise handwriting, good documentation skills, self-motivator, time management, goal oriented and effective interpersonal skills are also required. Must be able to apply mathematical concepts such as probability and statistical data, have strong computer skills including Microsoft Word, Excel, Power Point and Outlook, and also able to handle multiple projects simultaneously. Must be able to bend, stoop, and lift up to 50 pounds, as necessary.