Job Description

Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. We are looking for a Senior Documentation Control Specialist for a medical device manufacturing company .

Job Summary:

The Senior Documentation Control Specialist will support the corporate documentation control system, ensuring compliance with company policies, procedures, and regulatory requirements. This role involves creating, editing, and maintaining manufacturing and quality system documentation while leading document change processes with minimal supervision.

Responsibilities:

Change Control:

• Collaborate with Quality Assurance Management and other departments to generate, modify, and process document changes related to new products, equipment, and components.
• Ensure accuracy, clarity, and compliance of new and revised documents.
• Facilitate cross-functional review and approval of document changes, resolving issues and ensuring full participation.
• Assess how changes affect Bill of Materials (BOMs) and implement updates in Electronic Data Management Systems (e.g., Master Control, ERP).
• Prioritize and coordinate processing of change packets while maintaining high quality and efficiency.
• Recommend and implement improvements to the change control process.
• Support product launch teams by attending meetings and maintaining Quality Assurance (QA) deliverables.
• Conduct training on change control processes as needed.

File Maintenance and Auditing:

• Archive Quality Records, including Device History Records (DHRs), Change Packets, Design History Files, Validations, Complaints, and Receivers.
• Maintain and audit document control and QA department files to ensure compliance with GMPs, Federal Regulations, International Standards, and company procedures.
• Address Corrective/Preventive Action Requests related to document control.

Administration:

• Generate status reports and Management Operations Review reports.
• Collaborate with Department Managers to align department goals with corporate objectives.
• Represent the department in internal and external audits and other meetings as required.
• Perform additional duties as assigned.

Qualifications:

• High school diploma or equivalent required; Bachelor's degree in Business Administration, Management, or equivalent work experience preferred.
• Minimum of 5 years of experience in documentation control systems, preferably within a Medical Device Single Audit Program (MDSAP)/ISO and high-volume manufacturing environment.
• Strong knowledge of document change management.
• Advanced proficiency in English (writing, grammar, proofreading, redlining).
• Advanced computer skills (Microsoft Word, Excel, Access, and other Office software).
• Technical experience in developing and coordinating documentation systems.
• Excellent verbal communication and time management skills.
• Ability to work independently with meticulous attention to detail and lead multi-functional teams in document change processes.

Work Environment & Physical Demands:

• Hybrid role operating in both office and manufacturing environments, with flexible hours to meet project deadlines.
• Occasional travel by airplane or automobile may be required.
• Ability to lift up to 30 lbs regularly.
• Work involves 15% meetings and 85% desk work, including computer-based tasks, paperwork, and analysis.
• May require use of Personal Protective Equipment (PPE).

Benefits : Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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