Quality Systems & Compliance Lead – Medical Devices

MBC Talent Connections; Albany (GA); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Competitive salary

Performance bonus

Employer-paid medical/dental/vision

401(k) with match

Tuition reimbursement

Generous PTO

On-site position

Job summary

MBC Talent Connections is seeking a Quality Systems & Compliance Manager in Albany, GA to lead our quality and regulatory programs for medical device manufacturing. You will ensure device lifecycle compliance with ISO 13485, EU MDR, 21 CFR Part 820, and risk management per ISO 14971.

You will direct QA/QC activities, drive continuous improvement, manage audits, and develop training, labeling, and change-control processes to maintain inspection readiness and product safety.

Qualifications

• Minimum 5 years in pharmaceutical or medical device industries.
• At least 3 years in a supervisory or leadership capacity.
• Bachelor's degree in life sciences, engineering, or related field.

Responsibilities

• Oversee compliance activities across device lifecycle per ISO 13485, EU MDR, 21 CFR 820.
• Direct QA and QC activities including validation strategies and protocols.
• Develop training programs for all personnel.
• Manage internal and supplier audits and maintain inspection readiness.
• Administer the supplier quality program with vendors.
• Guide product documentation, design verification, and regulatory requirements.
• Approve labeling and artwork per international standards.
• Manage change controls and regulatory impact assessments.

Skills

Quality management

Regulatory compliance

Leadership

Cross-functional collaboration

Education

Bachelor's degree in life sciences, engineering, or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

MBC Talent Connections is seeking a Quality Systems & Compliance Manager in Albany, GA to lead our quality and regulatory programs for medical device manufacturing. You will ensure device lifecycle compliance with ISO 13485, EU MDR, 21 CFR Part 820, and risk management per ISO 14971.

You will direct QA/QC activities, drive continuous improvement, manage audits, and develop training, labeling, and change-control processes to maintain inspection readiness and product safety.