Position Description
The Quality Assurance Specialist administers document control and related quality records within the Quality Management System (QMS). This individual contributor supports QA's mission to define, maintain, and improve the QMS by keeping approved information current, changes traceable, and records complete and retrievable. The role focuses on controlled documents, Arena administration, training records, and documentation support for QA activities. The Specialist works with process owners and designated approvers and performs reviews or approvals within documented training and delegated authority.
Responsibilities
Controlled documents and change orders
- Process document and engineering change orders, verifying document details, supporting records, and approvals before release.
- Coordinate document creation, revision, approval, distribution, and archival, including effective dates and required implementation and training actions.
- Review documents for format, completeness, consistency, and cross-references. Resolve discrepancies with owners responsible for technical content and impact assessments.
- Maintain controlled documents and records, ensuring current revisions are available at points of use and superseded versions are controlled.
Arena administration and data integrity
- Administer Arena templates, workflows, attributes, and authorized user access under approved change controls; provide user support.
- Import and verify approved master data, resolve discrepancies, and maintain traceability of corrections.
- Support change assessments and validation through assigned checks, documented results, and evidence approved before implementation.
Training administration and user support
- Onboard employees into the QMS and assign training using approved role requirements and curricula, coordinating with managers responsible for role-specific competence.
- Maintain training records, track completion, follow up on overdue assignments, and escalate gaps to managers.
- Report training status and guide employees on document control procedures.
Quality records and audit support
- Maintain quality records under approved access, confidentiality, and retention requirements; retrieve documents and evidence for audits and inspections.
- Check assigned QA records for completeness and required approvals, return deficiencies to owners, and archive approved records, including patient-specific preproduction files and DHRs.
- Maintain supplier and other QMS files, track documentation due dates, and follow up with owners.
- Support controlled label templates, approved label data, assigned BarTender administration, and device identifier records under approved procedures.
- Identify recurring errors and recommend improvements to document control workflows and user guidance.
Qualifications
- 7+ years in document control or QA within a regulated industry, preferably medical devices.
- Working knowledge of controlled documents, change control, training records, and good documentation practices; familiarity with ISO 13485, applicable FDA quality system requirements, and MDSAP.
- Experience with an electronic QMS or product lifecycle management system; Arena experience preferred.
- Proficiency with Microsoft Office and accurate data entry and record retrieval.
- Strong attention to detail, organization, written communication, and follow-through; ability to coordinate with multiple functions and escalate missing evidence or overdue work.
- Experience supporting audits and electronic system changes preferred; BarTender or other controlled labeling system experience is beneficial.
Compensation
The anticipated annual base salary range for this position is $85,000 - $95,000. Individual compensation is determined based on factors such as experience, skills, education, certifications, and geographic location.
In addition to base salary, eligible employees may participate in incentive compensation programs and receive a comprehensive benefits package. Our benefits reflect our commitment to the health and well-being of our employees and their families and include 100% employer-paid medical, dental, and vision insurance premiums, a 401(k) plan with employer matching, and unlimited paid time off (PTO). Your recruiter can provide additional details about our total rewards package during the hiring process.
