QA Supervisor - DHR Review

Penumbra Inc. • Roseville, CA

46d • $71,000 - $98,000 • Onsite

About The Position

As a QA Supervisor of DHR Review, you will play a pivotal role in maintaining the integrity of our Quality systems and processes. You will be responsible for supervising and overseeing DHR Review areas of the Quality System and the DHR Reviewers who work in those areas.

Requirements

• A Bachelor's degree with 2+ years of experience, or equivalent combination of demonstrated education and experience
• Proficiency with Microsoft Office (e.g., Word, Excel, Access, PowerPoint, etc.)
• Demonstrated working knowledge of Medical Device regulations
• Solid problem solving, decision-making, and supervisory skills required
• High degree of accuracy and attention to detail
• Excellent organizational skills with ability to prioritize assignments while handling various assignments simultaneously

Nice To Haves

• Prior supervisory experience preferred

Responsibilities

• Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
• Manage the scheduling of DHR Reviewers for coverage, prioritization and workload
• Coordinate with internal customers to establish prioritizations and work though discrepancies
• Communicate and train internal customers when processes are changed
• Complete DHR Review when needed
• Analyze and generate trending data to support system effectiveness
• Evaluate procedures and work instructions for processing improvements and implement changes as necessary
• Support Quality System processes during internal and external regulatory audits
• Proactively seek system improvements while maintaining compliance to applicable requirements.
• Communicate Quality System issues to upper management, presenting solutions as appropriate

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 5,001-10,000 employees