Quality Assurance Coordinator

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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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Reports To: Quality Assurance Manager

FLSA Status: Non-exempt

Location: West Valley City Utah

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.

Key Responsibilities

To perform this job successfully an individual must be able to execute the following responsibilities satisfactorily:

• 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.

Desired Minimum Qualifications

• 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

Education & Experience

• 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.

TOOLS AND EQUIPMENT USED

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.

Skills & Competencies

• 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.

Tools & Equipment Used

• 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.

Physical Requirements

• 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).

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The absence of specific statements of duties does not exclude them.

Salary Pay Range:

Our salary ranges are determined by role level and location. Individual pay is determined by several factors including job-related skills experience and relevant education or training. In addition to base pay employees may be eligible for bonus commission equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire Employees are eligible for the following Total Rewards Integra LifeSciences

Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.

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