Sr Quality Technician

Freudenberg•Jeffersonville, IN

11d

About The Position

The Sr Quality Technician applies advanced knowledge of quality procedures and equipment in a regulated medical device manufacturing environment. The role independently resolves most issues, prioritizes tasks, supports training, and leads by example. It also serves as a resource for less-experienced colleagues and formally trains junior staff. The technician applies relevant FDA regulations and quality standards, supports product quality and testing, leads quality investigations and corrective actions, and participates in audits.

Requirements

3–5+ years of experience in the medical device industry, including at least 3 years in Quality Engineering or Quality Systems.
Proven experience with nonconformance management, CAPA, root cause analysis, and product quality.
Experience working within a regulated manufacturing environment.
Strong working knowledge of medical device quality and regulatory requirements, including FDA Quality System requirements, ISO 13485, EU MDR, and GMP.
Understanding of quality system requirements and industry best practices.
Experience managing and investigating nonconformances.
Experience leading CAPA activities and root cause investigations.
Experience with process validation and manufacturing process controls.
Experience with change control and change management.
Experience with software validation, as applicable.
Ability to analyze quality data, identify trends, and drive corrective and preventive actions.
Experience partnering with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.

Nice To Haves

Bachelor’s degree in Engineering, Quality, Biomedical Engineering, or a related technical field preferred; experience may be accepted in lieu of a degree.

Responsibilities

Apply advanced understanding of quality procedures and equipment, resolving most issues independently.
Prioritize tasks and support training.
Lead by example, formally train junior staff, and act as a resource for less-experienced colleagues.
Apply FDA regulations, ISO 13485, GMP principles, and other relevant standards.
Perform product testing, inspection, and statistical quality control.
Apply risk management methodologies and support post-market surveillance.
Lead CAPA investigations and implement sustainable corrective actions.
Use design control processes to ensure compliance with performance criteria.
Participate in internal and external audits.
Manage and investigate nonconformances, conduct root cause investigations, and address product quality issues.
Support process validation, manufacturing process controls, change control, and software validation as applicable.
Analyze quality data, identify trends, and drive corrective and preventive actions.
Partner with Manufacturing, Engineering, Operations, and other cross-functional teams to resolve quality issues.