Sr Quality Engineer

Sr Quality Engineer Interactive Resources Ir - 3.6 Gainesville, FL Job Details $130,000 a year 20 hours ago Qualifications Incident investigation techniques for hazard identification Preventive action implementation Regulatory compliance Production deviation management Corrective and preventive actions (CAPA) Production validation processes Quality risk management Biomedical regulatory compliance Hazard analysis Product quality failure

ISO 13485 FDA

regulations Product lifecycle management Failure analysis

Full Job Description Location:

Gainesville, Florida Type:

Direct Hire Job #11640

Salary:

$130000

Location Type:

On-Site The Senior Quality Engineer will partner closely with R D, Manufacturing, Supply Chain, Regulatory Affairs, Clinical, and Marketing teams to drive quality excellence throughout product development, commercialization, and sustaining engineering activities. This role will be responsible for leading quality initiatives related to design controls, risk management, verification and validation, process validation, supplier quality, CAPA, change control, and continuous improvement efforts. Bachelor's Degree in Engineering or related technical discipline. Minimum of 5 years of experience within an FDA regulated environment or a combination of FDA and highly regulated manufacturing environment. Demonstrated experience supporting products throughout the full lifecycle, including development, commercialization, and post-market support. Experience supporting process validation activities, including

IQ/OQ/PQ.

Strong understanding of design controls and product lifecycle management processes. Experience with risk management methodologies, including ISO 14971, DFMEA, hazard analysis, and risk file maintenance. Working knowledge of

FDA 21 CFR

Part 820, ISO 13485, and applicable global regulatory requirements. Experience leading or supporting verification and validation activities. Experience with CAPA systems, root cause analysis, and nonconformance investigations. Preferred Qualifications Advanced degree in Engineering or related technical field. Experience supporting orthopedic implants, joint reconstruction systems, or other orthopedic medical device products. Familiarity with GD&T principles, inspection methods, and metrology systems. Experience working directly with suppliers on qualification, quality improvement, and readiness initiatives. Demonstrated ability to lead continuous improvement projects and drive quality-focused business results. Prior experience mentoring junior engineers or serving as a technical lead within a cross-functional product team.