Release Analyst

• Prepare and release product documentation.
• Process Change Notifications (CNs).
• Maintain product data in PLM systems.
• Review labeling and packaging components.
• Perform labeling proofs and quality audits.
• Release electronic manuals (eManuals).
• Support new product launches.
• Verify UDI registration requirements.
• Maintain Device Master Records (DMR).
• Analyze process metrics and improvements.
• Identify root causes of issues.
• Collaborate with cross-functional teams.
• Ensure compliance with quality standards.
• Support continuous process improvements.

• Bachelor’s degree with 2+ years’ experience, or Master’s with 6+ months.
• Experience in documentation or product release.
• Strong attention to detail.
• Good analytical and problem-solving skills.
• Proficient in Microsoft Office.
• Strong written and verbal communication.
• Ability to manage multiple priorities.
• Ability to work independently and in teams., * Medical device industry experience.
• Experience in regulated environments.
• Knowledge of FDA, ISO, EN, or GMP standards.
• Experience with PLM systems.
• Lean or Six Sigma knowledge.
• Experience with quality systems.
• Familiarity with eManuals and labeling processes.
• Experience with UDI and DMR documentation., * Bachelor’s (Required), * Configuration management: 5 years (Required)
• Release management: 5 years (Required)
• Medical Device: 2 years (Required)

4.44.4 out of 5 stars 5761 2nd St NE, Minneapolis, MN 55432 $60 - $65 an hour - Contract