QA Supervisor - DHR Review

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.

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 through 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

Requirements

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; Willingness and ability to work on site; Ability to lift and move up to 25 pounds; Ability to move between buildings and floors; Ability to remain stationary and use a computer or other standard office equipment for an extensive period of time each day; Ability to read, prepare emails, and produce documents and spreadsheets; Ability to move within the office and access file cabinets or supplies, as needed

Nice to have

Prior supervisory experience preferred

Benefits

Competitive compensation package plus a benefits and equity program, when applicable; 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, 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)