Oferta de trabajo: Global Regulatory Services Quality Compliance Proj

Empresa
Humera
Ubicación
Maple Grove, MN
Publicado en
el 13 de marzo de 2025

Global Regulatory Services Quality Compliance Proj | Maple Grove, MN

Global Regulatory Services Quality Compliance Proj

Maple Grove, MN

Are you ready to take your career to the next level? Join our client, a global leader in medical devices, as a Global Regulatory Services Quality Compliance Project Lead!

This role offers the chance to drive critical regulatory process alignment across six business units, ensuring compliance and procedural excellence. If you have a passion for quality systems, CAPA management, and regulatory affairs, this is the perfect opportunity to make a meaningful impact.

What You’ll Do:

  • Lead procedural updates and implement emerging regulations across multiple business units.

  • Manage and oversee CAPA processes, ensuring accuracy, completeness, and effectiveness.

  • Drive change order activities, develop training materials, and facilitate implementation.

  • Execute CAPA Review Board and Management Review forums.

  • Structure procedures, work instructions, and guidance documents within Abbott’s Quality Systems.

  • Organize and lead team meetings, document meeting minutes, and track action items.

  • Identify opportunities for continuous improvement and cross-functional collaboration.

What We’re Looking For:

  • Strong procedural writing expertise.

  • Hands-on CAPA management experience.

  • Excellent project management skills—ability to organize and lead procedural development meetings.

  • 5+ years in a regulated industry (medical devices, pharmaceuticals, etc.).

  • Familiarity with Regulatory Affairs processes and responsibilities.

Preferred Qualifications:

  • Bachelor’s Degree in a relevant field.

  • Experience with Quality Systems and technical writing.

  • Strong communication skills (both written and verbal).

  • Proven success in managing multiple projects and priorities.

  • Proficiency in Microsoft Word, Visio, and PowerPoint.

  • Experience with Windchill (a plus but not required).

Post Date: 03.13.2025

Salary: $90.00 /hr - $105.00 /hr

Shift: 1st

Benefits: Health care insurance benefits available first of the month following 60 days of employment. Thirty (30) hours worked per week must be averaged in order to maintain coverage. 401k enrollment is available per the Secure Act guidelines. Earned Sick and Safe time is accrued and can be used per the State of MN guidelines.

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If you would prefer to speak directly to a Humera Staffing Consultant, please call us at 612-977-1440 and reference OrderID 819068

Estos datos son entregados por una API de CareerOneStop sitio externo, patrocinada por la Administración de Empleo y Capacitación del Departamento de Trabajo de los Estados Unidos. Las ofertas de trabajo provienen de NLx sitio externo, que está copatrocinado por la Asociación de Empleadores Directos sitio externo y la Asociación Nacional de Agencias de Fuerza Laboral del Estado sitio externo.