*completed 4 year degree (no exceptions)
*background check required

The Release Analyst (RA) works under general supervision to prepare, process, and implement quality systems, configuration management, and product design documentation deliverables to support Product components (i.e., manuals, instructions for use (IFUs), cards, package labels, package configurations, etc.) and Product Release end items. This individual works with a team to release and control electronic manuals on the websites.


A Day in the Life

Configuration Management:

• Coordinates with Product Release and Configuration Assurance to prepare and route Engineering Change Orders and Change Actions (CO/CAs).
• Fulfill internal customer requests for electronic versions of labeling.
• Review parts prior to CO/CA release to ensure that all requirements for end item components and specifications are met, escalating issues as necessary.
• Create and maintain end items in a product lifecycle management (PLM) system.


Quality System:

• Coordinate with Product Release and Quality Systems to prepare and route product design documentation.
• Perform change control audits of labeling and packaging components.
• Perform proofs of labeling components and print vendor labeling.
• Ensure personal understanding of all quality policy/system items that are applicable.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.


eManuals Release:

• Perform the eManuals Release Administrator (ERA) role by staging and releasing manuals to the eManuals website for the operating unit, including specifying the attributes.
• Coordinate activities surrounding the qualification and release of eManuals for product launches.
• Participate in user acceptance testing for the eManuals website as needed.
• Follow established editorial guidelines for populating the attributes of eManual records on the eManuals website.
• Participate in requirements definition and testing for new features on the eManuals website.
• Work closely with internal and external partners to assist in troubleshooting problems with content, quality, or schedule and negotiate resolution of issues.


Product Release:

• Analyze and verify requirements for Unique Device Identification (UDI) registration.
• Support Device Master Record (DMR) indexing as needed.
• Contributes to metrics that provide data for process measurement.
• Contributes to diagrams and evaluates existing processes.
• Collects data to identify root cause of problems.
• Measures performance against process requirements.
• Surveys and analyzes best practices for techniques and processes.
• Perform other related tasks as assigned.



Must Haves

• Bachelors degree with 2+ years of job-related experience, OR
• Masters degree with 6+ months of job-related experience




Nice to Haves

• Experience working in a regulated environment.
• Experience working in a medical device environment.
• Experience working with FDA, ISO, EN, and/or GMP standards.
• Proven, strong detail-oriented work skills.
• Proven ability to easily adapt to multi-task and shift priorities effectively and expediently.
• Demonstrated proficiency with common software packages (e.g., Word, Excel, Adobe Reader).
• Proven ability to easily adapt to and master proprietary programs.
• Demonstrated ability to work independently and with a team.