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Bus Proc Impvmt Analyst - Exempt Bus Proc Impvmt Analyst - Exempt

Mindlance

Minneapolis, MN

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JOB DETAILS
SKILLS
Acceptance Testing, Adobe Product Family, Analysis Skills, Auditing, Best Practices, Change Control, Configuration Management, Data Collection, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Medical Equipment, Metrics, Microsoft Excel, Microsoft Word, Multitasking, Negotiation Skills, Package Layout Design, Performance Metrics, Problem Solving Skills, Product Design, Product Documentation, Product Lifecycle Management, Product Requirements Document (PRD), Product/Service Launch, Requirements Management, Root Cause Analysis, Support Documentation, Systems Administration/Management, Team Player, Test Requirements
LOCATION
Minneapolis, MN
POSTED
30+ days ago


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 finished goods. This individual works with a team to release and control Neuromodulation and Pelvic Health electronic manuals on the *** eManuals websites.
A Day in the Life
Configuration Management:
o Coordinates with Product Release and Configuration Assurance to prepare and route Change Notifications (CNs).
o Fulfill internal customer requests for electronic versions of labeling.
o Review parts prior to CN release to ensure that all requirements for components and specifications are met, escalating issues as necessary.
o Create and maintain finished goods and models in a product lifecycle management (PLM) system.
Quality System:
o Coordinate with Product Release and Quality Systems to prepare and route product design documentation.
o Perform change control audits of labeling and packaging components.
o Perform proofs of labeling components and print vendor labeling.
o Ensure personal understanding of all quality policy/system items that are applicable.
o Follow all work/quality procedures to ensure quality system compliance and high-quality work.
eManuals Release:
o Perform the eManuals Release Administrator (ERA) role by staging and releasing manuals to the eManuals website for the operating unit, including specifying the attributes.
o Coordinate activities surrounding the qualification and release of eManuals for product launches.
o Participate in user acceptance testing for the eManuals website as needed.
o Follow established editorial guidelines for populating the attributes of eManual records on the eManuals website.
o Participate in requirements definition and testing for new features on the eManuals website.
o Work closely with internal and external partners to assist in troubleshooting problems with content, quality, or schedule and negotiate resolution of issues.
Product Release:
o Analyze and verify requirements for Unique Device Identification (UDI) registration.
o Support Device Master Record (DMR) indexing as needed.
o Contributes to metrics that provide data for process measurement.
o Contributes to diagrams and evaluates existing processes.
o Collects data to identify root cause of problems.
o Measures performance against process requirements.
o Surveys and analyzes best practices for techniques and processes.
o Perform other related tasks as assigned.
Must Haves
Bachelor s degree with 2+ years of job-related experience, OR
Master s 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.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

About the Company

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Mindlance