Penumbra
General Summary
The Quality Control Training Specialist II will develop and execute training programs to support the stability and growth of our Quality Inspection environments. You will perform tasks as assigned to increase the knowledge and understanding of GMP and Quality processes, which include, but are not limited to: New Inspector Training, Train the Trainer, Lead Training and Quality System (QSR) initiatives, etc. You will also develop and maintain current programs and materials and independently develop new programs as future needs are identified from cross-functional sources (e.g. SMEs, inspectors, supervisors, production), and work independently to solve problems and actively participate in departmental process improvements linked to training.
Specific Duties and Responsibilities
• Develop, revise & maintain current training programs and materials (e.g., PowerPoint presentations, assessments, certification tests, worksheets, job aids, etc.) with minimal guidance from management.
• Train and test personnel for comprehension in inspecting medical devices per Penumbra’s Quality System.
• Provide required training on SOPs, ECOs, WIs, MQIs and Quality System requirements to inspectors.
• Provide training in other Penumbra manufacturing locations when needed.
• Respond to training requests identified by supervisors and managers.
• Drive resolution of process and/or documentation issues including origination and implementation of change requests.
• Responsible for completion of personnel training records and training record monitoring and maintenance such as scanning, filing, matrices.
• Resolve and respond to training issues and questions from throughout the Quality organization.
• Recommend solutions for systemic training related issues.
• Communicate effectively with all levels of the organization to determine training needs.
• Design, develop and update training content as needed to ensure optimal learning experience and retention.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.
Position Qualifications
• Bachelor’s degree with 3+ years of quality systems experience in a regulated device or pharmaceutical environment, and 3+ years of learning and development or training experience, ideally acquired in the medical device, pharmaceutical or biotechnology industries, or an equivalent combination of education and experience in an equivalent industry are required.
Additional Qualifications
• Strong project and process management skills.
• Strong verbal, written and interpersonal communication skills.
• Strong presentation skills.
• Ability to independently develop content (PowerPoint) and simplify complex processes.
• Basic math skills are required, as well as proficiency with Microsoft Word, Excel, Access, and Power Point.
• Strong attention to detail, organization, and teamwork skills.
• Basic knowledge of GMP/QSR requirements.
• Ability to work in the Alameda office during swing shift hours of: 3 pm to 11:30 pm.
Working Conditions
• General office, production, and cleanroom environments.
• Willingness and ability to work on site in Alameda.
• Potential exposure to blood-borne pathogens
• 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: $72,817 – $103,644 + $300 Shift Differential
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, 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.
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.
If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra’s AAP Policy Statement.
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