Sr. Global QMS Documentation & Records Control Specialist

We Make Life More Rewarding and Dignified

Location
:
Libertyville
Department
:
Quality

The Sr. Global QMS Documentation and Records Control Specialist is responsible for managing the end-to-end lifecycle of controlled documents and quality records. This involves ensuring that the control of quality procedures and records complies with all applicable global requirements/standards (e.g., FDA QMSR, ISO 13485). This role is essential for ensuring that medical device products are designed, manufactured, and maintained to validated specifications every time and maintaining audit/inspection readiness.

Hollister Incorporated operates in a hybrid work environment. For this position, we require the Associate to be onsite a minimum of 4 days per week

Change Control Management: Coordinate the review, approval, and release of new or revised documents (e.g., GPDs, WIDs, drawings, specifications) via the electronic Document Management System (eDMS).

System Administration Support: Help manage system administration, user access, and resolve minor access/system function issues/elevate to IT for support, as required.

Quality Record Maintenance: Audit and archive critical QMS documents and records, including Internal Audit Records, External Inspection Records, Approved Supplier Records, etc. to ensure they are properly retained and made available, as necessary.

Audit & Inspection Support: Act as a primary point of contact for document retrieval during internal audits and external regulatory inspections (e.g., FDA, Notified Bodies).

Training Administration: Link released documents to training requirements ensuring timely assignment of training requirements to associates.

Good Documentation Practices (GDP): Enforce GDP across the organization, identifying and correcting errors in metadata, templates, signatures, and versioning.

• Archival & Retention: Manage physical and electronic archives, overseeing retention schedules and secure off-site storage through approved vendors (e.g., Iron Mountain).
• Process document changes and track approval workflows
• Work with internal stakeholders to collect, distribute and update required documents as required
• Provides reports and metrics regarding the performance of document control management
• Supports driving continues improvement regarding the document control process and system
• Supports investigation and driving corrective actions regarding the document control process
• Maintenance of the Approved Vendor List
• Other duties as assigned

Manage the creation, review, approval, and distribution of critical documents (e.g., Standard Operating Procedures [SOPs], Work Instructions [Wis], and Engineering Change Controls (ECCs).

Ensuring only the most current, effective versions of documents are available for use while properly retiring and archiving obsolete versions to prevent unintended misuse.

Oversee the maintenance of critical QMS files (e.g., Internal Audit Records, External Inspection Records, Approved Supplier Records)

Serve as a primary point of contact for procuring records during internal audits or external regulatory inspections.

Partner with the Training Department to facilitate the proper linkage of QMS documents to employee training requirements in a timely manner.

Ensures compliance with record retention policies and disposal according to established procedures.

• Communicate effectively via email, phone, and virtual platforms.
• Collaborate across departments to support organizational goals.
• Participate in cross-functional meetings and initiatives.
• Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
• Prepare reports and dashboards for internal stakeholders.
• Ensure data accuracy and confidentiality in compliance with company and legal standards.
• Manage multiple priorities and deadlines in a fast-paced environment.
• Lead or support special projects aligned with departmental objectives.
• Demonstrate initiative in identifying process improvements or automation opportunities.
• Serve as a point of contact for internal and external stakeholders.
• Resolve inquiries and issues with professionalism and discretion.
• Maintain secure handling of sensitive information.
• Support audits and regulatory reporting as needed.

• Bachelor's Degree with 2-5 years of related experience

• Candidates must have 5-8 years of experience to be considered for a Sr. level.
• Experience with an eDMS (e.g., Veeva Vault, Master Control, etc.)
• Equivelant experience in lieu of Bachelors degree will be considered
• Strong understanding of document control in the medical device industry
• Strong understanding of applicable standards (e.g., FDA QMSR, ISO 13485, ISO 14971)
• Experience in regulated environments; medical device industry is highly desirable.
• Proficiency in…