QA Manager, Training Services

Penumbra • Alameda, CA

1d • $137,000 - $194,000 • Onsite

About The Position

As a Quality Assurance Manager of Training Services, you will play a pivotal role in maintaining the integrity of our Quality System and processes. You will be responsible for overseeing the direction and supervision of the Quality Training System, Training Services, and leading projects to ensure compliance with Penumbra procedures and regulatory requirements. What You’ll Work On Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. Ensure the structure of all group activities is in alignment with corporate goals and initiatives. Coordinate global training activities to ensure compliance with regulatory requirements, ensuring that all team members are appropriately trained. Provide additional analysis of situations, reviewing various factors to solve problems, and proactively seek and implement improvements. Evaluate procedures and work instructions for process improvements, recommend changes to policies and procedures, and implement changes, as necessary. Act as subject matter expert for Training and participate in cGMP compliance inspections by the FDA, customers, and/or other regulatory bodies. This includes retrieval of quality documents/records/trend data and any other documentation requested during these inspections as well as defending Quality System processes. Own and drive any NCR’s and CAPA’s related to the Training System. Communicate and train internal customers when processes are changed. Responsible for providing Quality and MasterControl Orientation training. Resolve and respond to quality system training issues and questions from throughout the organization. Recommend, implement, and document solutions for systemic training related issues. Analyze regulatory, business, and customer requirements, as well as current industry best practices; propose and implement any required changes or improvements to the Training System. Design, develop and implement Training System curriculum in conjunction with functional leadership. Promote a safe, positive, and inclusive work environment.

Requirements

• A Bachelor's degree with 8+ years of experience in Quality Assurance, Quality Control, biotechnology, document control, or related field, or equivalent combination of education and experience
• 5+ year of experience in a position with direct management of people
• Proficiency with Training Systems (such as MasterControl, SAP Litmos)
• Ability to manage multiple, complex priorities within demanding timeframes with attention to detail
• Proficiency with Microsoft Office Professional Suite (Word, Excel, Access, PowerPoint)
• Knowledge of the FDA QSR, ISO13485, and the MDD/MDR
• Demonstrated strong supervisory experience and performance required
• Solid problem solving, decision-making, and leadership skills are required
• Strong oral, written and interpersonal communication skills
• High degree of accuracy and attention to detail
• Exercises judgment based on policies and management guidance to determine appropriate action

Nice To Haves

• Experience with MDSAP preferred

Responsibilities

• Select, manage, train, and develop staff.
• Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
• Ensure the structure of all group activities is in alignment with corporate goals and initiatives.
• Coordinate global training activities to ensure compliance with regulatory requirements, ensuring that all team members are appropriately trained.
• Provide additional analysis of situations, reviewing various factors to solve problems, and proactively seek and implement improvements.
• Evaluate procedures and work instructions for process improvements, recommend changes to policies and procedures, and implement changes, as necessary.
• Act as subject matter expert for Training and participate in cGMP compliance inspections by the FDA, customers, and/or other regulatory bodies.
• Own and drive any NCR’s and CAPA’s related to the Training System.
• Communicate and train internal customers when processes are changed.
• Responsible for providing Quality and MasterControl Orientation training.
• Resolve and respond to quality system training issues and questions from throughout the organization.
• Analyze regulatory, business, and customer requirements, as well as current industry best practices; propose and implement any required changes or improvements to the Training System.
• Design, develop and implement Training System curriculum in conjunction with functional leadership.
• Promote a safe, positive, and inclusive work environment.

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 501-1,000 employees