Quality Assurance Coordinator at Integra… · West…

Summary: Integra LifeSciences is dedicated to creating change in healthcare and shaping future treatment pathways. The Quality Assurance Coordinator is responsible for coordinating key Quality Control processes to ensure effective execution of inspection activities and nonconforming material management, while also providing training and guidance to Quality Control Technicians. 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 Required Qualifications: - Experience in quality inspection or quality control within a regulated manufacturing environment - Knowledge of ISO, FDA and QMSR concepts and guidelines - 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 - 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 - 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 Required Skills: Quality inspection, Quality control, Nonconforming material management, ISO standards, FDA regulations, Quality Management System Regulation (QMSR), Inspection tools, Calipers, Optical comparator, Pin gauges, R.O.D.A.C. plate testing, Viable air sampling, Particulate monitoring, Microsoft Excel, Microsoft Word, Electronic Quality Management Systems (eQMS), Technical drawing interpretation, Specification interpretation, Work instruction interpretation Benefits: Bonus, Commission, Equity, Medical, Dental, Vision, Life insurance, Short- and long-term disability, Business accident insurance, Group legal insurance, Savings plan (401(k))