QA Manager, Training Services (Medtech)

TL;DR

QA Manager, Training Services (Medtech): Overseeing the Quality Training System and staff management to ensure compliance with regulatory requirements and internal procedures with an accent on cGMP compliance and process improvement. Focus on managing global training activities, solving systemic training issues, and defending Quality System processes during FDA and ISO inspections.

Location: Must be able to work on site in Alameda, CA

Salary: $137,000 - $194,000 / year

Company

hirify.global is a global healthcare company focused on designing and manufacturing innovative therapies for challenging medical conditions.

What you will do

• Select, manage, and develop staff, providing ongoing feedback through performance reviews and development plans.
• Coordinate global training activities to ensure compliance with regulatory requirements.
• Act as a subject matter expert for Training during cGMP compliance inspections by the FDA and other regulatory bodies.
• Own and drive NCRs and CAPAs related to the Training System.
• Design, develop, and implement Training System curriculum in collaboration with functional leadership.
• Evaluate and implement improvements to policies, procedures, and work instructions.

Requirements

• Bachelor's degree with 8+ years of experience in QA, QC, biotechnology, or document control.
• 5+ years of experience in a position with direct people management.
• Proficiency with Training Systems such as MasterControl or SAP Litmos.
• Deep knowledge of FDA QSR, ISO13485, and MDD/MDR.
• Willingness and ability to work on site in Alameda, CA.
• Strong oral, written, and interpersonal communication skills.

Nice to have

• Experience with MDSAP.

Culture & Benefits

• Collaborative teamwork environment focused on revolutionizing treatment for devastating diseases.
• Generous benefits package including medical, dental, vision, life, and disability insurance.
• 401(k) plan with employer match.
• Paid parental leave, 11 paid company holidays, and a minimum of 15 days of accrued vacation per year.
• Paid sick time in compliance with applicable laws.