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Document Control & Quality Management Specialist in San Jose, CA at Nelson

Date Posted: 2/9/2018

Job Snapshot

Job Description

Job Number: 2115993

Document Control & Quality Management Specialist
San Jose, CA
Compensation based on experience

The Compliance and Quality Assurance Supervisor will provide hands-on support for all Quality and Regulatory compliance functions, including management of RA/QA and Worker Training systems. The RA/QA Supervisor shall continuously improve the RA/QA processes and tools in support of quality and compliance objectives. This position reports to the Head of RA/QA.

* Responsible for the issuance, tracking, maintenance, storage and retrieval of records associated with product and Quality Assurance and Training Programs.
* Create, develop and implement appropriate document control policies, procedures, systems and programs to ensure document control expectations are achieved
* Participates in formal problem solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes and Client-side findings.
* Supports the Head of RA/QA for all Quality and Regulatory plans, actions, implementation and upskilling as the Business grows.
* Keeps abreast of the requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of regulatory compliance questions and issues.
* Organizes and documents training sessions and presentations in support of quality objectives
* Maintain Employee training records
* Supports all facets of the internal, Supplier and Agency audit system including scheduling, auditing, reporting, and corrective actions.

* 5 years document control, document management, data management, or similar related experience in a manufacturing or engineering environment
* Proficient computer skills with MS office programs
* Experience with automated document control software is strongly desired
* Working knowledge of Quality Management Systems - 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.
* Marked ability to learn new applicable standards, determine how they apply to the Business and provide related guidance cross-functionally.
* Strong interpersonal skills with the aptitude to be a team player and Leader; setting a professional tone and establishing a cooperative partnership within the department and other areas of the Company to effectively resolve problems.
* Ability to interpret trends and data, translating the information into actions, outcomes and improvements
* Excellent documentation skills, with a solid process orientation and effective attention to detail
* In-depth knowledge of regulatory quality principles and technical tools (technical writing, problem analysis, control charts and other quality methodologies) with the ability to train others.

Document Control & Quality Management Specialist
San Jose, CA

About Nelson:

For more than 45 years, we've been passionate about helping people find jobs they love - rewarding jobs that further career goals. At Nelson, we partner with companies that have outstanding reputations. Working with innovative startups to Fortune 500 companies, our skilled recruiters have access to opportunities beyond what you can find on your own.

With Nelson, you'll get the most out of your career. Together, we'll set career goals and find you a position where your skills shine. Whether you are looking for a position in: accounting & finance, administration, computer gaming, digital media, engineering, human resources, legal, light industrial, manufacturing, or technology, Nelson helps place people in full-time, temporary, temp-to-hire, project, and contract positions. For a full listing of jobs, go to: and click "Find Work."