QA/RA Manager, Medical Devices & Regulatory Compliance

Digitailor; Houston (TX); Sur place; USD 107 000 - 171 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) with company match

Parental leave and tuition assistance

Résumé du poste

RRD is seeking a Manager – QA/RA to oversee the site Quality Management System and Regulatory affairs for assigned locations. You will lead a team of Quality Engineers, Supervisors, Specialists and Auditors, ensuring sustainable compliance with ISO 13485, ISO 14971, FDA QSR and related standards throughout medical device and pharma operations.

You will drive product release, process validation strategies, and risk-based approaches, coordinating with customers and suppliers, and guiding

Qualifications

• Bachelor's degree in a technical or life sciences field.
• 5+ years of team leadership experience in QA/RA.
• 3+ years medical device or pharma QA/RA experience.
• ISO 13485:2016, ISO 14971:2019 and FDA QSR knowledge required.

Responsabilités

• Lead and maintain site QMS and regulatory compliance for medical devices and pharma.
• Manage a team of Quality Engineers, Supervisors, Specialists and Auditors.
• Oversee internal audits and risk-based improvements; drive CAPAs and root-cause analysis.

Connaissances

Team Leadership

Quality Management

Regulatory affairs

Risk Management

Communication skills

Formation

Bachelor's Degree in Technical or Life Sciences

ISO Lead Auditor certification

Outils

PC systems

Microsoft Office Suite

Description du poste

RRD is seeking a Manager – QA/RA to oversee the site Quality Management System and Regulatory affairs for assigned locations. You will lead a team of Quality Engineers, Supervisors, Specialists and Auditors, ensuring sustainable compliance with ISO 13485, ISO 14971, FDA QSR and related standards throughout medical device and pharma operations.

You will drive product release, process validation strategies, and risk-based approaches, coordinating with customers and suppliers, and guiding