Quality Analyst Job Listing at Kelly Services in Santa Rosa, CA (Job ID 9374288)

Description

Kelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking a Quality Analyst for a long-term engagement at one of our Global Medical Device Manufacturing clients located in Santa Rosa, CA.
 
Our client is a clinical-stage medical device company advancing transseptal left atrial appendage (LAA) closure. The growing incidence of atrial fibrillation and medical device developments have rapidly expanded the market.

This role is a full-time, fully benefited position.   As a Kelly employee, you will be eligible for our enhanced benefits, 50% paid Medical & Dental, 401K, and a variety of other benefits to choose from.  You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.  All Kelly employees in this group receive annual performance reviews.

Quality Analyst 

The Analyst, Quality Documentation is responsible for maintaining a Document Control system that meets regulatory, quality and company requirements. Activities will include but are not limited to, word processing, distributing, and maintaining documents and records both manual and within the Electronic Quality Management System (eQMS).

Description of Work

• Oversee the complete document lifecycle, including creation, review, approval, distribution, training, retrieval, and obsolescence to ensure full compliance.
• Reviews, edits, and formats, controlled documents according to approved procedures and templates, monitors document status and approval notifications, distribution and archiving.
• Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedures.
• Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks.
• Ensure the management of controlled documents are processed in a timely manner while safeguarding quality, accuracy and adherence to company and regulatory requirements.
• Maintains revision and approval status of all controlled documents.
• Responsible for issuing, executing, closing and archiving controlled documentation (including lab notebooks, logs, forms, procedures, test methods, specifications, batch documentation and labels and maintain issuance log).
• Assure applicable site personnel are adequately trained in the policies and procedures of the document control system.
• Oversee the training program and ensure compliance with regulations, procedures, and best industry practices.
• Support the maintenance of the document control system, including formatting, numbering, record retention and change control.
• Support improvement initiatives to strengthen document management processes and systems.
• Assist in development and use of document templates, standards, and conventions.
• Maintain filing and archiving of paper records.
• Issue and manage electronic records in the eQMS.

Required Skills & Experience

• Bachelor's degree or equivalent education and work experience.
• Minimum 3 years of experience providing document management and record control in an FDA-regulated environment, preferably medical device manufacturing.
• Knowledge of U.S. FDA medical device regulations (21 CFR 820) and/or International Standards (ISO 13485).
• Experience using electronic Quality Management System solutions in a regulated environment.
• Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution skills.
• Ability to make decisions and recommendations related to the role.
• Strong ability to multi-task and to meet business deadlines.
• Excellent organizational skills with an ability to think proactively and prioritize work.
• Ability to work with minimal supervision.
• Demonstrated experience with Microsoft Office suite and Adobe Acrobat.

Important information: 
Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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