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QA Manager, Training Services
Education Training
💰 Salary 11,417 CAD–16,167 CAD/mo (137,000 CAD–194,000 CAD/yr)
📊 Market 6,500 CAD–8,500 CAD/mo (78,000 CAD–102,000 CAD/yr)
About the Company
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. Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant. No. 5 on the Greater Bay Area Manufacturers List, San Francisco Business Times, 2020 100 Fastest-Growing Companies, Fortune, 2019 Review our community guidelines for LinkedIn here: https://bit.ly/2Jmbw83. Medical Equipment Manufacturing Specialties: Neurointerventional devices, Stroke treatment, Vascular access, Thrombectomy systems, Interventional radiology, Medical device innovation
Responsibilities
- ● 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
- ● + 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
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