Senior Quality Engineer - Combination Product

medmix • Flowery Branch, GA

2d

About The Position

Provide Quality Engineering support for combination products, molding, assembly and automated manufacturing lines, and medical device operations. Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable global regulatory requirements. Participate in or lead risk management activities per ISO 14971, including DFMEA, PFMEA, hazard analyses, and control strategy development. Own and maintain Quality System documentation including work instructions, specifications, and control plans. Lead or support investigations for nonconformances, deviations, and customer complaints through root cause analysis using tools such as 5 Whys, Fishbone, Fault Tree Analysis, or DOE. Develop and implement effective Corrective and Preventive Actions (CAPA); verify and validate effectiveness. Monitor manufacturing risks and develop mitigation strategies focused on patient safety and product quality. Lead compliance efforts for handling scheduled drug products . Assist in training compliance DEA requirements

Requirements

• Technical Knowledge: Proficiency in AutoCAD/SolidWorks, GD&T (Geometric Dimensioning and Tolerancing), and statistical software.
• Methodologies: Strong experience with Lean manufacturing, Six Sigma, and DMAIC (Define, Measure, Analyze, Improve, Control).
• Analytical Skills: Ability to interpret data, charts, and reports to drive improvements.
• Education/Experience: Usually requires a bachelor’s degree in engineering (Mechanical, Industrial, Chemical) and 5+ years of experience in regulated environments.

Responsibilities

• Provide Quality Engineering support for combination products, molding, assembly and automated manufacturing lines, and medical device operations.
• Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable global regulatory requirements.
• Participate in or lead risk management activities per ISO 14971, including DFMEA, PFMEA, hazard analyses, and control strategy development.
• Own and maintain Quality System documentation including work instructions, specifications, and control plans.
• Lead or support investigations for nonconformances, deviations, and customer complaints through root cause analysis using tools such as 5 Whys, Fishbone, Fault Tree Analysis, or DOE.
• Develop and implement effective Corrective and Preventive Actions (CAPA); verify and validate effectiveness.
• Monitor manufacturing risks and develop mitigation strategies focused on patient safety and product quality.
• Lead compliance efforts for handling scheduled drug products .
• Assist in training compliance DEA requirements

Benefits

• An innovative, vibrant and agile culture
• Growth opportunities in a globally successful and dynamic business on a growth trajectory
• Excellent employee benefits including: Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability
• Employee Savings Plan / 401k with 100% employer match

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level