Quality Assurance Coordinator

Integra LifeSciences•West Valley City, UT

3d•$20 - $27•Onsite

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The QA Coordinator is responsible for coordinating key Quality Control processes to ensure effective execution of inspection activities, environmental monitoring, and nonconforming material management within the facility. This role serves as Process Owner for the Non-Conforming Material Management process and ensures proper identification, documentation, review, and coordination of disposition activities for nonconforming materials. The QA Coordinator works closely with the Quality Assurance Manager to identify pending quality tasks, prioritize activities, and coordinate their execution across the Quality Control team and other departments. The position provides training and guidance to Quality Control Technicians and other personnel involved in quality processes. While the role primarily coordinates quality activities, the QA Coordinator remains qualified to perform inspections when operational needs require additional support or coverage.

Requirements

Experience in quality inspection or quality control within a regulated manufacturing environment preferred
Knowledge of ISO, FDA and QMSR concepts and guidelines preferred
Excellent communication and organizational skills
Outstanding attention to detail
Strong interpersonal skills and ability to work with others in a positive and collaborative manner
Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
Ability to utilize multiple gauges and measurement tools for inspection.
Knowledge of various MS Office applications such as: Word and Excel
Ability to train new inspectors in the use of inspection equipment and gauging
1 – 5 years of experience in quality inspection or a similar role within the medical device, pharmaceutical, or regulated manufacturing industry.
High School Diploma or Equivalent; combination of education and experience will be considered.
Ability to use inspection tools such as calipers, optical comparator, pin gauges, etc. as other general office equipment.
Ability to perform RODAC Plate testing, Viable Air Sampling and Particulate Monitoring using calibrated equipment.
Strong knowledge of inspection techniques, measurement tools, and quality control methods.
Ability to interpret technical drawings, specifications, and work instructions.
Excellent attention to detail and documentation skills.
Proficiency in Microsoft Office (Excel, Word, Outlook) and ability to use electronic quality management systems (eQMS).
Effective communication and collaboration skills to work across departments.
Inspection tools and gauges, including calipers, micrometers, and visual inspection equipment.
Computers and general office equipment (telephone, printer, scanner, etc.).
Electronic documentation systems for tracking nonconformances and quality data.
Ability to sit, stand, bend, and move throughout the facility for extended periods.
Repetitive use of hands and fingers to operate equipment and perform inspections.
Must be capable of using a keyboard for data entry and documentation.
Reasonable accommodations may be made in accordance with the Americans with Disabilities Act (ADA).

Responsibilities

Coordinate and support the execution of quality control activities across the facility.
Collaborate with the Quality Assurance Manager to identify, prioritize, and monitor quality-related tasks and objectives.
Facilitate execution of assigned quality system processes in accordance with internal procedures and regulatory requirements.
Provide guidance and training to Quality Control Technicians and personnel involved in quality processes.
Support coordination of inspection activities and remain qualified to perform inspections when operational support is required.
Support the execution and monitoring of environmental monitoring activities and ensure timely review of related data.
Serve as process owner or coordinator for assigned quality system processes as defined in controlled procedures or standard work documents.
Support document control activities and serve as backup for document control and training coordination functions when required.
Promote compliance with cleanroom behavior, personal practices, and gowning procedures to ensure contamination control standards are maintained.
Communicate status of quality activities and escalate issues that may impact timelines, compliance, or quality objectives.
Support internal, external, and regulatory audits as required.