Quality Assurance Manager — Medical Devices (GMP/QSR)

SSI Diagnostica Group; Radford (VA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

TechLab, part of the SSI Diagnostica Group, seeks a Quality Assurance Manager to lead QA and Document Control and sustain the global quality system.

You will report to the Vice President of Global Quality Assurance and drive regulatory compliance, CAPA, training, and continuous improvement across a medical device manufacturing environment.

This role includes audits, supplier management, and product release oversight in a collaborative, patient-outcome focused team.

Qualifications

• B.A. or B.S. in a life sciences field with 10+ years in GMP/QSR environments.
• 3+ years supervisory experience and strong leadership.
• Proven ability to implement QMS frameworks in regulated industries.

Responsabilités

• Oversee QA and Document Control teams and maintain the quality system.
• Ensure compliance of the QMS with global regulatory requirements.
• Lead audits and host internal/external audits.
• Manage supplier and material release processes.
• Drive CAPA, training, and continuous improvement.

Connaissances

Leadership

Regulatory knowledge

QMS implementation

GMP/QSR experience

Formation

B.A./B.S. in life sciences

Description du poste

TechLab, part of the SSI Diagnostica Group, seeks a Quality Assurance Manager to lead QA and Document Control and sustain the global quality system.

You will report to the Vice President of Global Quality Assurance and drive regulatory compliance, CAPA, training, and continuous improvement across a medical device manufacturing environment.

This role includes audits, supplier management, and product release oversight in a collaborative, patient-outcome focused team.