Global QA Training & Compliance Manager

Penumbrainc; Alameda (CA); On-site; USD 137,000 - 194,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) match

Parental leave

Holidays & vacation

Paid sick time

Job summary

Penumbra, Inc. is seeking a Quality Assurance Manager of Training Services to oversee the Quality Training System, Training Services, and drive projects ensuring compliance with Penumbra procedures and regulatory requirements.

You will coordinate global training activities, manage staff, and act as SME for Training in cGMP inspections by FDA and others, owning NCRs and CAPAs related to Training Systems. A strong background in QA, training platforms, and leadership is required.

Qualifications

• Bachelor's degree with 8+ years in QA or biotech.
• 5+ years of direct people management experience.
• Proficiency with Training Systems (MasterControl, SAP Litmos).
• Ability to manage multiple, complex priorities within demanding timeframes with attention to detail.
• Proficiency with Microsoft Office Suite (Word, Excel, Access, PowerPoint).
• Knowledge of FDA QSR, ISO13485, and the MDD/MDR; MDSAP preferred.
• Strong supervisory experience and leadership skills.
• Excellent written and verbal communication skills.

Responsibilities

• Select, manage, train, and develop staff with performance reviews and development plans.
• Coordinate global training activities to ensure regulatory compliance.
• Own NCRs and CAPAs related to the Training System.
• Provide Quality and MasterControl Orientation training.
• Resolve and respond to quality system training issues and implement solutions.
• Analyze regulatory, business, and customer requirements to improve the Training System.
• Design, develop, and implement Training System curriculum with leadership.
• Promote a safe, inclusive work environment.

Skills

Staff management

Regulatory knowledge

Quality training

Attention to detail

Communication

Problem solving

Leadership

cGMP compliance

Auditing

MasterControl

SAP Litmos

Education

Bachelor's degree

Tools

MasterControl

SAP Litmos

Job description

Penumbra, Inc. is seeking a Quality Assurance Manager of Training Services to oversee the Quality Training System, Training Services, and drive projects ensuring compliance with Penumbra procedures and regulatory requirements.

You will coordinate global training activities, manage staff, and act as SME for Training in cGMP inspections by FDA and others, owning NCRs and CAPAs related to Training Systems. A strong background in QA, training platforms, and leadership is required.