Senior Quality Engineer - 2600

FloodGate Medical; Birmingham (AL); On-site; USD 90,000 - 120,000; Full time

Job summary

FloodGate Medical is seeking a Senior Quality Engineer to support production of a patient-safety-focused product line on the manufacturing floor in Birmingham, AL. You will be the technical backbone of quality, driving continuous improvement and ensuring design controls are followed.

You will lead CAPA/NCR investigations, own supplier quality and risk management, and serve as a key decision-maker where compliance and production intersect, championing integrity and accountability in every action.

Qualifications

• 3+ years of hands-on quality engineering experience in medical device manufacturing.
• Fluency in ISO 13485, QSR, CAPA, and design controls — translate regulatory requirements into floor-level actions.
• Proactive, see-it-and-fix-it mindset driving continuous improvement.

Responsibilities

• Drive continuous improvement on the manufacturing floor.
• Lead CAPA/NCR investigations and root-cause analysis.
• Own supplier quality and risk management responsibilities.
• Serve as a key decision-maker where compliance and production intersect.

Skills

Quality engineering

CAPA investigations

Regulatory knowledge

Job description

A growing medical device manufacturer is seeking a Senior Quality Engineer to support the production of a specialized, patient-safety-focused product line. This is a newly created role driven by company growth, reporting directly to the Director of Quality Assurance/Regulatory Affairs. You\'ll be the technical backbone of quality on the manufacturing floor- driving continuous improvement, leading CAPA/NCR investigations, owning supplier quality and risk management, and stepping in as a key decision-maker when compliance and production intersect. The company operates with a strong, values-driven culture built around integrity and accountability, the kind of place where doing things the right way isn\'t just policy, it\'s how people actually operate day to day.

Why You\'ll Love It

• Real ownership from day one — this is a newly created seat with genuine influence over how quality operates, not a role where you\'re boxed into someone else\'s process
• Mission-driven, high-character culture — you\'ll work alongside people who take accountability seriously and treat their work as more than just a job
• Tangible impact — your work directly protects the safety of physicians and patients in real clinical settings, not abstract compliance for its own sake

Ideal Candidate

• 3+ years of hands-on quality engineering experience in medical device manufacturing (or strong adjacent experience in a highly regulated industry)
• Fluency in ISO 13485, QSR, CAPA, and design controls — able to translate regulatory requirements into practical, floor-level action
• A proactive, "see it and fix it" mindset — someone who drives continuous improvement rather than just maintaining the status quo