Manufacturing Quality Engineer - Med Devices

Femasys Inc.; Suwanee (GA); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Comprehensive health benefits

401(k) with match

Meaningful impact in women’s health

Job summary

Femasys Inc. in Suwanee, GA is seeking a Manufacturing Quality Engineer to support production and ensure medical devices meet quality and regulatory requirements.

You will collaborate with Manufacturing, Operations, Supply Chain, and Engineering to drive improvement from concept to market. The role emphasizes CAPA investigations, process validation, and inspection, with exposure to FDA 21 CFR 820 and ISO 13485; a hands-on, fast-paced environment with opportunities to influence product quality

Qualifications

• Bachelor’s degree required with 5+ years in Quality Assurance or Quality Engineering in medical devices.
• Strong knowledge of FDA QSR 21 CFR Part 820 and ISO 13485.
• Experience with design controls and risk management is required.
• Excellent communication and project management skills.

Responsibilities

• Provide day-to-day quality engineering support to manufacturing operations.
• Lead nonconformances, CAPAs, deviations and investigations.
• Support process validation, change control and qualification activities.
• Review and approve quality documentation and records.
• Collaborate with manufacturing, operations, supply chain and engineering to drive improvements.

Skills

Quality Assurance

Quality Engineering

Project management

Statistical analysis

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in Engineering or Science

Tools

MS Office

GxP/Regulatory knowledge

Job description

Femasys Inc. in Suwanee, GA is seeking a Manufacturing Quality Engineer to support production and ensure medical devices meet quality and regulatory requirements.

You will collaborate with Manufacturing, Operations, Supply Chain, and Engineering to drive improvement from concept to market. The role emphasizes CAPA investigations, process validation, and inspection, with exposure to FDA 21 CFR 820 and ISO 13485; a hands-on, fast-paced environment with opportunities to influence product quality