Quality Manager,Kitting Job Buford area,Georgia USA,Quality Assurance

Join to apply for the Quality Manager, Kitting role at Resonant Clinical Solutions

Provide Quality leadership over a single site within the Kitting business unit, including overall responsibility for the administration of the Quality Management System, budget, and compliance with applicable regulations and standards.

Key Responsibilities:

Ensure compliance with 21 CFR 820 (QSR/QSMR) and/or ISO 13485 at the site level.

Administer Quality subsystems such as Document Control, Training, Complaints, CAPA, Nonconformance, Supplier Control, and Internal Auditing.

Host customer, regulatory, and notified body inspections/audits.

Serve as SME for Quality topics, providing technical support internally and externally.

Advise management on regulations and standards, and provide strategic insights.

Coordinate with departments to ensure compliance and meet Quality needs facility-wide.

Manage staffing levels and work assignments.

Support continuous improvement initiatives.

Coach and develop team members.

Perform other duties as assigned.

Qualifications:

Bachelor’s degree preferred.
6-8+ years in a regulated industry (medical devices, IVDs, pharmaceuticals).
At least 3 years of leadership experience.

Knowledge, Skills, and Abilities:

Strong interpersonal and management skills.
Working knowledge of ISO 13485, 21 CFR, and 820 (QSR).
Excellent communication skills.
Effective time management and prioritization skills.

Work Environment & Physical Effort:

Primarily office environment; may include production floor and warehouse areas.
Frequent walking, standing, bending, reaching, and lifting up to 30 lbs.

Travel: Up to 10% domestic and international travel.

We are an equal opportunity employer.

#J-18808-Ljbffr