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Quality Control Training Specialist II

1 month ago

Oakland, California, United States Penumbra Full time
Job Summary

The Quality Control Training Specialist II will play a critical role in developing and executing training programs to support the stability and growth of our Quality Inspection environments. This position will perform tasks as assigned to increase the knowledge and understanding of GMP and Quality processes, which include, but are not limited to:

  • Developing, revising, and maintaining current training programs and materials with minimal guidance from management.
  • Training and testing personnel for comprehension in inspecting medical devices per Penumbra's Quality System.
  • Providing required training on SOPs, ECOs, WIs, MQIs, and Quality System requirements to inspectors.
  • Providing training in other Penumbra manufacturing locations when needed.
  • Responding to training requests identified by supervisors and managers.
  • Driving 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.
  • Resolving and responding to training issues and questions from throughout the Quality organization.
  • Recommending solutions for systemic training-related issues.
  • Communicating effectively with all levels of the organization to determine training needs.
  • Designing, developing, and updating training content as needed to ensure optimal learning experience and retention.
  • Adhering to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
  • Understanding relevant security, privacy, and compliance principles and adhering to the regulations, standards, and procedures applicable to the Company.
  • Ensuring other members of the department follow the QMS, regulations, standards, and procedures.
Requirements
  • Bachelor's degree required with three plus (3+) years of quality systems experience in a regulated device or pharmaceutical environment, and three plus (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.
  • 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 PowerPoint.
  • 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.
Benefits

Penumbra offers a competitive compensation package, including an annual base salary range of $72,817 - $103,644, plus a $300 shift differential. We also offer a generous benefits package for eligible employees, including 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 is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment where everyone feels valued and respected. If you are passionate about quality and training, and want to be part of a team that is revolutionizing the treatment of some of the world's most devastating diseases, please submit your application.