Release Analyst

Job Title Release Analyst Exempt 13186

Number of Positions 1
Job Location Minneapolis Minnesota 55432. Typical Week: 3 days on site 2 days work from home.)
Job Start Date 3/25/24
Job End Date 3/28/25

Job Description

The Release Analyst (RA) works under general supervision to prepare process and implement quality systems configuration management and product design documentation deliverables to support Neuromodulation and Pelvic Health Labeling and Packaging 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 Neuromodulation and Pelvic Health electronic manuals on our eManuals 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 jobrelated experience OR
* Masters degree with 6 months of jobrelated 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 detailoriented work skills.
* Proven ability to easily adapt to multitask 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.

Top 3 skills:

1. Experience working with data inside systems where quality attention to detail and efficiency are important.
2. Experience collaborating with internal partners to implement changes and/or manage data within controlled systems
3. Experience supporting multiple projects with potentially competing priorities knowing how to manage priorities between projects daytoday knowing when to escalate proven ability to be accountable to commitments