Werfen · 21 hours ago
Coordinator I, Quality Records
San Diego, CA, US
Full-time
Onsite
Entry Level
1+ years expWerfen is a growing, family-owned company specializing in diagnostics in areas such as Hemostasis and Acute Care Diagnostics. The Quality Records Coordinator is responsible for reviewing and auditing Manufacturing and Quality Control records, primarily focusing on Device History Records to ensure timely product release.
Health CareHospitalManufacturingMedical Device
Responsibilities
Review DHRs for assigned products; as appropriate, approve product release through the Enterprise Resource Planning system (ERP)
Audit DHRs to ensure accuracy, legibility, and traceability
Continually work to achieve assigned review time goals; meet unscheduled in workload as necessary to ensure timely release of product
Responsible to scan/archive completed DHRs
Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve questions, inconsistencies, or missing data issues
Remain current with all specifications and requirements on which quality records are based
Remain up to date with current Good Manufacturing Processes (cGMP), as well as with manufacturing’s material/product process flow
Provide data and metrics related to accuracy, completeness and cycle times for records being reviewed
Ensure priority to urgent matters
Provide additional administrative support as directed
Participate in regulatory audits as needed
Ensure and maintain compliance with the company’s quality system requirements through training and adherence to policies, procedures, and processes
Other duties as assigned
Carries out duties in compliance with established business policies
Interface with all functions and levels of management as needed
Other duties as assigned, according to the changing needs of the business
DHR Review and Release
Deviation process (Affected DHRs)
Nonconformance process
Validation DHR Review
Qualification
Required
High school diploma; Bachelor's degree (Life Sciences) a plus
Minimum one year's previous related Quality Records/Quality Assurance experience preferred; previous experience within a regulated medical device manufacturing or pharmaceutical environment strongly preferred
Knowledge of cGMP, GDP, FDA, and ISO preferred
Working knowledge of Microsoft Office
Experience with large enterprise resource planning (ERP) system and accounting software packages preferred
Previous regulatory audit experience a plus
Technical writing background/experience a plus
Must be self-motivated and could work with minimal supervision; must also be able to work as part of a team
Good communication, organizational, and time management skills; ability to pay close attention to detail
Ability to work as part of a team
Ability to identify and correct problems
Preferred
Minimum one year's previous related Quality Records/Quality Assurance experience preferred; previous experience within a regulated medical device manufacturing or pharmaceutical environment strongly preferred
Knowledge of cGMP, GDP, FDA, and ISO preferred
Experience with large enterprise resource planning (ERP) system and accounting software packages preferred
Previous regulatory audit experience a plus
Technical writing background/experience a plus
Company
Werfen
Werfen is a developer, manufacturer and distributer of IVD testing solutions.
5001-10000 employees
H1B Sponsorship
Werfen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Dominique Petitgenet
Chief Operating Officer, Transfusion & Transplant
Ken Vogel, HCS
Human Resources Business Partner
Recent News
MarketScreener
2025-12-17
2025-12-08
Company data provided by crunchbase