Release Analyst

The Release Analyst works under general supervision to prepare, process, and implement quality systems, configuration management, and product design documentation deliverables. This role supports labeling and packaging components for Neuromodulation and Pelvic Health products and releases electronic manuals. The ideal candidate will possess strong attention to detail and experience working within complex, interconnected systems to maintain high-quality data., * Coordinate with Product Release and Configuration Assurance to prepare and route Change Notifications (CNs)

• Fulfill internal customer requests for electronic versions of labeling
• Review parts prior to CN release to ensure all requirements for components and specifications are met
• Create and maintain finished goods and models in a product lifecycle management (PLM) system
• Coordinate with Quality Systems to prepare and route product design documentation
• Perform change control audits and proofs of labeling and packaging components
• Perform the eManuals Release Administrator (ERA) role by staging and releasing manuals to the eManuals website
• Coordinate activities surrounding the qualification and release of eManuals for product launches
• Analyze and verify requirements for Unique Device Identification (UDI) registration
• Support Device Master Record (DMR) indexing as needed
• Plan, perform and implement process improvement initiatives
• Organize, lead, and facilitate cross-functional project teams
• Develop metrics that provide data for process measurement
• Collect data to identify the root cause of problems

• Bachelor’s degree with a minimum of 2+ years of relevant experience, internship experience is included
• High attention to detail with a focus on quality, particularly with data entry and system setup
• Ability to understand and navigate complex, interwoven systems and processes
• Experience working on cross-functional teams in a matrixed organization
• Practical knowledge and demonstrated competence within the job area

Desired Skills:

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

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:

• Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average)
• Behavioral Health Platform
• Medical, Dental, Vision
• Health Savings Account
• Voluntary Hospital Indemnity (Critical Illness & Accident), For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all of our available career opportunities, please visit us at our website.