Sr. Quality Systems Manager

Gallin Associates; Gainesville (FL); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Gallin Associates seeks a senior Quality Systems leader to oversee site-wide quality programs and a team focused on regulatory compliance and continuous improvement. The role emphasizes audits, NC/CAPA, and post-market surveillance across medical device or pharma quality systems.

The ideal candidate brings 10+ years in regulated environments, 5+ years in Quality/Regulatory Affairs, and 3+ years of staff management, with hands-on experience in FDA Part 820, Part 1271, ISO 13485, or AATB standards.

Qualifications

• Bachelor's degree in life sciences or related field preferred.
• 10+ years' experience in a regulated industry, preferably Medical Devices or Pharma.
• 5+ years in Quality or Regulatory Affairs.
• 3+ years managing staff.
• Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards.
• Experienced in supporting NC/CAPA and audit responses.

Responsabilités

• Manage site-wide Quality Systems programs and team responsible for driving quality activity and compliance including managing audits, document control, NC/CAPA and post-market surveillance activity.

Connaissances

Audits

Document control

NC/CAPA

Post-market surveillance

Regulatory affairs

Team leadership

Formation

Bachelor's degree in life sciences or related field

Description du poste

CLIENT CANNOT SPONSOR/TRANSFER WORK VISA AUTHORIZATION

Manage site-wide Quality Systems programs and team responsible for driving quality activity and compliance including managing audits, document control, NC/CAPA and post-market surveillance activity.

REQUIREMENTS

• Bachelor's degree in life sciences or related field preferred
• 10+ years' experience in a regulated industry, preferably Medical Devices or Pharma
• 5+ years in Quality or Regulatory Affairs
• 3+ years managing staff
• Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards
• Experienced in supporting NC/CAPA and audit responses