Job Title : Sr. Quality System Analyst Training
Location: Santa Clara, CA.
- Provides quality systems support for the maintenance and improvement of a global quality/training management systems. Performs quality activities as directed, including but not limited to training, coordination and preparation for external/internal audits, managing training & competency CAPAs, and driving continuous improvement initiatives. Manages training projects & initiatives that assure the Organization is in continuous alignment with Client quality system standards and global expectations.
- Implements process-improvement projects, including rollout oversight of a new global learning management system (LMS), and/or integration activities.
- Reviews weekly HR employee reports & partners with managers of newly hired and transferring employees to verify required training is identified on a training matrix and assigned within the LMS. Initiates additional assignments and adjustments to the training matrix as needed for role.
- Working within the LMS assigns training, creates/revises assignment groups and curricula whenever new training is added or course material is revised.
- Generates training compliance reports/metrics (weekly, monthly, biannually) and actionable data for employee managers, Global Compliance Officer, and management reviews.
- Documents completion of training in the LMS based upon learner's participation in classroom, workshop, webinar, OJT, lecture/seminar, or other types of training. Manages and maintains training rosters (both electronic and paper-based) according to Good Documentation Practices and document retention rules.
- Responsible for creating, modifying and retiring courses in the LMS, as well as managing the scheduling of planned training events. Manages enrollment, cancelation, and wait listing of course participants.
- Participates in select scheduled and ad-hoc internal audits or inspections.
- Develops and maintains processes/procedures/documentation for ensuring compliance to internal and external requirements.
- Provides project management leadership to various Quality-driven initiatives and represents Quality Training as-needed for representation in Company-wide improvement initiatives.
- Provides training in quality/regulatory concepts and tools, Learning Management System (LMS), and applicable training programs and instructional materials.
- Interfaces with CAPA task owners to drive correct actions and documentation in accordance with FDA regulations and international standards.
- Reviews and maintains policies and procedures to ensure compliance with government regulations and international Quality System Regulations (QSR) including quality system standards such as 21 CFR Parts 803, 806, 820 and ISO 13485/9001 and ISO 14971, etc.
* 5 years related experience in relevant medical diagnostic/device industry, including 1-2 years of direct Quality operations. 3 years experience of learning management system oversight. Experience focused on quality systems, regulatory affairs/compliance or project management.
* Familiarity with relevant international ISO Standards (13485, 62304, 14971), and regulations (European medical/in-vitro devices directives, 21 CFR - part 820). * ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus.
* Ability to manage work process within an electronic Learning Management System (LMS) (i.e., SAP LSO, Cornerstone, MediaLab, Oracle, Plateau Systems, etc.).
* Demonstrated knowledge & proficiency of word processing and spreadsheets.
* Strong reasoning, interpersonal and organizational skills.
* Ability to work in a fast paced changing environment and cross-functionally with all levels of employees.
* Excellent oral and written communication skills. Ability to prepare and present information to groups.
* High degree of accuracy, quality, and initiative with the ability to work independently.
* Thorough understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
* Thorough understanding of a quality system and its development, documentation and implementation with respect to standards and requirements.
* Ability to develop and implement quality training programs including: tracking, analyzing, reporting and problem solving.
* Bachelors' degree in Biological/Life Sciences, Engineering or related field, or equivalent combination of education and work experience.
* Certification or certificates in the fields of training & development, education, instructional design or relevant learning fields of study, preferred.
* ASQ Certified Quality Auditor certification or equivalent nationally recognized certification, a plus.
Central Business Solutions, Inc,
37600 Central Ct.
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677