QA & Regulatory Affairs Manager - Medical Devices

RRD; Houston (TX); Presencial; USD 107.000 - 171.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Disability insurance

Life insurance

Parental leave

Tuition assistance

Employer/partner discounts

Descripción de la vacante

RRD is seeking a Manager – QA/RA to lead the site Quality Management System and Regulatory affairs for assigned locations, ensuring compliance with ISO and FDA requirements in regulated markets.

The role directs a team of quality professionals, oversees software quality and product releases for medical devices, and guides validation strategies while coordinating with customers and suppliers to maintain quality agreements.

Formación

• Bachelor's degree in a technical or life sciences field.
• 5+ years related work experience including team leadership.
• 3 years medical device or pharma QA or RA experience.
• Advanced training in ISO 13485:2016, ISO 14971:2019 and FDA QSR.
• Ability to interpret federal regulations and procedures for manufacturing.
• ISO class cleanrooms experience desirable and sterile production qualification.
• ISO Lead Auditor certification or ASQ Auditor.
• Proficient with Microsoft Word/Excel and standard PC tools.

Responsabilidades

• Lead and maintain the site's Quality Management System (QMS).
• Manage Quality Engineers, Supervisors, Specialists and Auditors.
• Oversee software quality activities and product releases for medical devices.
• Guide process validation strategies and QMS improvements.
• Ensure compliance with ISO 13485, ISO 9001, ISO 14971, ISO 11137, EUMDR and FDA QSR.
• Coordinate root cause analyses and CAPAs.
• Develop quality agreements with customers and suppliers.
• Monitor QMS metrics, CAPAs, NCMRs, and preventive actions.
• Lead internal audits and supervise quality staff across sites.

Conocimientos

Team Leadership

Regulatory compliance

Quality Management System

Problem-solving

Communication skills

Educación

Bachelor's degree in Technical or Life Sciences

ISO Lead Auditor certification or ASQ Auditor

Herramientas

Microsoft Office Suite

PC systems

Descripción del empleo

RRD is seeking a Manager – QA/RA to lead the site Quality Management System and Regulatory affairs for assigned locations, ensuring compliance with ISO and FDA requirements in regulated markets.

The role directs a team of quality professionals, oversees software quality and product releases for medical devices, and guides validation strategies while coordinating with customers and suppliers to maintain quality agreements.