Quality Assurance Specialist

SUMMARY The Quality Assurance Specialist supports the business by performing a variety of quality-related activities. The Quality Assurance Specialist will spend approximately half their time working within the compliance team in QA/RA and various personnel in Operations to ensure procedures are executed as written to ensure product and quality system requirements are met. The remaining time will be spent working on other quality tasks related to this position, mostly on their own, but occasionally in a team setting.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Reviews and revise quality system documents and procedures as required to meet compliance requirements, remediate identified gaps or implement improved controls. Maintain quality system procedures and work instructions and take appropriate action when non-compliance is observed through gap analyses, root cause determinations, coordination of nonconformances and corrective actions. Write and manage the routing, reviewing, and publishing of equipment, system, software, process, and test method validation documentation within a validated electronic quality management system. Monitor the proper setup, scheduling, and completion of system preventive and corrective maintenance within a validated electronic quality management system; including, when required, reporting of metrics. Initiate and/or participate in resolution of quality concerns through approved systems, including, but not limited to corrective or preventive actions (CAPA), nonconformances (NCR), reworks, and temporary deviations (TDN). Perform CAPA verifications. Ensure compliance with regulatory and quality system requirements. Serve as liaison between various areas within Operations to effectively promote quality. Perform internal audits and support external audits by regulatory agencies, ISO registrars, and customers. Independently assess situations, propose solutions, and determine acceptability of actions (by self and others) to ensure the integrity of the quality system. Other duties as assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Ability to follow requirements of quality standards and regulations such as ISO 13485 and 21 CFR Part 820 Ability to effectively communicate quality system requirements to diverse groups at all levels of the organization Ability to work as a part of a team and in a collaborative manner, in a rapidly evolving environment.' Knowledge of European IVD directive or regulation is preferred. Keen eye for detail Decision-making skills Computer literate, including basic operation of Microsoft Office applications such as Office, Excel, and Visio EDUCATION and/or

EXPERIENCE

High school diploma or equivalent required, B.S or A.S. preferred. A minimum of 2-years of experience is required in the Quality discipline. Familiarity with

ISO 13485, FDA 21 CFR

Part 820, and IVDD and IVDR is strongly preferred.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EQUAL OPPORTUNITY EMPLOYER

PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

STATEMENT

of

OTHER DUTIES DISCLAIMER

This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.