The Quality Training Manager is responsible for supporting all aspects of the QC Inspector training & certification program and ensuring compliance with Penumbra procedures and regulatory requirements. 

This includes developing, implementing and building training content as well as certification quizzes to ensure competency of QC inspectors. 

• Select, develop, train and manage a team of Quality Training Specialists

• Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans

• Oversee the QC Inspector Training and Certification Program, which is designed to evaluate personnel for competency before inspecting medical devices per Penumbra’s Quality System.

• Design, Develops and implement training curricula and/or recommends programs to enhance learning goals and objectives

• Selects or develops training aids, demo models, multimedia visual aids, computer tutorials, and reference works to enhance QC training program 

• Develop and maintain training materials and content (e.g. PowerPoint presentations, assessments, certification tests, worksheets, job aids, etc.) from the training program

• Provide QC training & certification in other Penumbra manufacturing locations when needed

• Evaluates procedures and work instructions for processing improvements, recommends changes to policies and procedures and implement changes as necessary

• Responsible for resolving and responding to training issues within the QC department

• Evaluates effectiveness of training programs and analyze regulatory, business and customer requirements or relevant data to propose and implement the improvements to the QC training & certification program

• Recommends, implements and documents solutions for systemic training related issues

• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures 

• Ensure other members of the department follow the QMS, regulations, standards and procedures

• Perform other work-related duties as assigned

• Bachelor’s degree with 8+ years of related experience in the fields of Education or Training or Biomedical/Life Sciences, or equivalent combination of education and experience 

• Proficiency with Learning Management Systems, Microsoft Office Professional Suite (Word, Excel, Access, PowerPoint) 

• Knowledge of FDA QSRs, ISO standards, 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 

• Strong presentation skills

• High degree of accuracy and attention to detail 

• General office, laboratory, and cleanroom environments 

• Potential exposure to blood-borne pathogens

• Requires some lifting and moving of up to 25 pounds 

• The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. 

• Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception. 

• Travel to other Penumbra sites may be required

•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, an employee stock purchase plan, 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.