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Quality System Manager – Document Control and Training
Requisition ID: 9687180423
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality System Manager – Document Control and Training to be located in Milpitas, CA.
Johnson & Johnson Vision (JJV), is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the J&J Vision brands brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
You, the Quality System Manager – Document Control and Training will be responsible for all functions related to document control process such as change management process/procedures, change orders, life cycle management (LCM) electronic database and working with internal customers to manage change control priorities. Lead training management system assessment and improvements. Responsible for providing oversight of the training and qualification programs and ensure the training effectiveness of the program by developing and implementing effective processes and tools for identifying training needs developing training content, monitoring and reporting compliance to the program. Mentor and develop staff involved in the preparation, documentation and dissemination of controlled documents, records management & training in accordance with ISO, GMP standards.
You, Quality System Manager – Document Control and Training will:
- Manage & oversee Document Control, Training & Records Management processes, system administration, performance, reporting and updates.
- Ensure effective interactions at a departmental level to efficiently incorporate departmental activities into overall company strategies and quality systems.
- Be responsible for overseeing the Document Control and Training department staff and will manage 6 to 9 subordinates.
- Ensure compliance with Federal, State and Local regulations pertaining to training, GMP/QSR, ISO13485 and associated regulatory agencies through effective change management.
- Assist Department Managers to develop plan and revise procedures and implement changes/programs for the site.
- Assist during FDA inspections, Notified Body, customer audits and other third party Quality System evaluations.
- Provide Quality Management Systems assistance for all facilities.
- Provide subject matter expertise during audits; investigate and respond to Quality System issues identified.
- Participate in project management/performance team meeting on behalf of the quality department in order to provide ideas, methods or processes for unit/company performance improvement.
- Work on complex assignments with high degree of independence; provide recommendations and resolve problems
- Perform other job-related duties as assigned.
- A Bachelor's Degree is required.
- A minimum of 8 years of previous work experience within a highly regulated environment.
- Experience in Document Control, Records & Training management experience in an ISO/FDA environment is required.
- A Minimum of 3-5years people management experience (experience managing, leading and developing a Quality team) is required.
- Experience with Quality Systems based on 21 CFR 820 and ISO 13485 Quality System Requirements is preferred.
- Solid understanding and experience using electronic document control system is preferred.
- This position will be located in Milpitas, CA and may require up to 15% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
AMO Manufacturing USA, LLC (6240)