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.
What You Contribute
• 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
• Experience with MDSAP preferred
• 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
Working Conditions
General office environment. Willingness and ability to work on site. Business travel from 0% - 10%. Requires some lifting and moving of up to 25 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range: $137,000 - $194,000 / year
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
• 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).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.