Quality Analyst

Kelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking an Analyst, Quality Documentation 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 LAA is a small pouch in the left atrium of the heart that is a major contributor to thromboembolic stroke in patients with atrial fibrillation. It has developmental, ultra-structural, and physiological characteristics distinct from the left atrium proper. 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.

Analyst, Quality Documentation

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

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, 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.