Global QMS Documentation & Records Control Specialist

We Make Life More Rewarding and Dignified

Location: Libertyville

Department: Quality

Summary

The 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

Responsibilities

Coordinate the lifecycle of controlled documents including creation, review, approval, release, distribution, revision, and retirement within the electronic document management system.

Maintain, audit, archive, and retrieve critical quality management system records including internal audit records, external inspection records, approved supplier records, and related quality documentation.

Serve as a primary point of contact for document and record retrieval in support of internal audits and external regulatory inspections.

Support training administration by linking released QMS documents to applicable associate training requirements.

Promote compliance with good documentation practices by identifying and resolving issues related to metadata, templates, signatures, versioning, and controlled document accuracy.

Manage physical and electronic archives, retention schedules, secure off-site storage through approved vendors, and maintenance of the Approved Vendor List.

Provide reports and metrics on document control performance to support compliance, visibility, and process monitoring.

Support continuous improvement initiatives, investigations, and corrective actions related to document control processes and systems.

Essentials of the role

• Experience supporting document control, records management, or quality systems within a regulated environment.
• Working knowledge of electronic document management systems, change control processes, and good documentation practices.
• Ability to maintain accurate records, manage competing priorities, and support audit or inspection readiness activities.
• Strong attention to detail, organizational skills, and ability to collaborate with cross functional and global teams.

Essential Functions of the Role

• 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.

Education & Work Requirements

• Bachelors Degree with 2-5 years of related experience

Education & Work Preferences

• Experience with an eDMS (e.g., Veeva Vault, Master Control, etc.)
• Equivalent experience in lieu of Bachelors degree may 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 Microsoft Office (specifically advanced Word formatting)
• Ability to work independently and in a focused manner
• Strong interpersonal communication and customer service skills
• Learning, technology, innovation and improvement orientated
• High energy, collaborative and team oriented
• Technology orientated (use of AI and other tools)
• Exceptional Attention to Detail: Ability to spot a missing signature or a minor typo in a multi-page document.
• Aptitude Toward Structure and Organization: Capability to manage and catalog thousands of active and archived documents and records while maintaining support of day-to-day document management needs.
• Analytical and Problem Solving Skills

Competencies

• Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
• Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
• Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
• Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
• Live The Schneiders' Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.
• Mid-year Rating and Comments for Competencies
• Mid-year Rating and Comments for Goals

Our Total Rewards package in aggregate is above market and includes competitive pay, paid time off programs, peer-to-peer recognition, health and life insurance, wellness programs and incentives, and generous retirement savings.

• The anticipated base pay range for this position is $62,000 - $87,000 yearly. The actual salary varies based on applicants location, education, experience, skills, abilities, and other legitimate business factors.
• This position is also eligible to participate in the Hollister Corporate Bonus Plan.
• The Company's health and welfare benefits include medical, prescription, dental, vision, spending/savings accounts, disability, company paid (parental and caregiver) leaves, statutory leaves/disability programs, accident, life, wellbeing, education assistance, adoption assistance, and voluntary benefit programs.
• The Company's 401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants "safe harbor" matching contributions.
• The Company's paid time off benefits include: 11 paid holidays, paid vacation based on length of service and exempt/non-exempt status, and sick days based on statutory requirements and/or exempt/non-exempt status.
• The Company's additional benefits include: education assistance and adoption assistance benefit programs.

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 35989