QA Supervisor - DHR Review

TL;DR

QA Supervisor (DHR Review): Supervising DHR Review team and maintaining quality systems in medical device manufacturing with an accent on staff management, process compliance, and system improvements. Focus on scheduling reviewers, analyzing trends, coordinating priorities, and supporting regulatory audits.

Location: Onsite in Roseville, CA

Salary: $75,000 - $100,000 / year

Company

Global healthcare company designing, developing, manufacturing, and marketing innovative therapies for challenging medical conditions.

What you will do

• Select, manage, train, and develop DHR Review staff with performance reviews and development plans.
• Manage scheduling, prioritization, and workload for DHR Reviewers.
• Coordinate with internal customers on priorities and resolve discrepancies.
• Train internal customers on process changes and perform DHR Reviews when needed.
• Analyze trending data, evaluate procedures for improvements, and implement changes.
• Support Quality System processes during internal and external regulatory audits and communicate issues to management.

Requirements

• Bachelor's degree with 2+ years of experience or equivalent.
• Proficiency with Microsoft Office (Word, Excel, Access, PowerPoint).
• Demonstrated knowledge of Medical Device regulations.
• Prior supervisory experience preferred.
• Solid problem-solving, decision-making, and supervisory skills.
• High accuracy, attention to detail, and organizational skills.

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Competitive compensation plus benefits including medical, dental, vision, life insurance, 401(k) with match, paid parental leave, 11 paid holidays, 15+ days vacation, and paid sick time.
• Opportunity to contribute to revolutionizing treatments for devastating diseases.