QA Supervisor - DHR Review

Penumbra, Inc.; Roseville (CA); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Benefits package

401(k) with employer match

Paid parental leave

Vacation and holidays

Job summary

Penumbra, Inc. in California seeks a QA Supervisor of DHR Review to lead and develop the DHR Review staff, ensuring the integrity of our Quality System and related processes. The role supervises DHR Review areas, coordinates with internal customers, analyzes data, and supports regulatory audits. A BS degree with 2+ years’ experience and MS Office proficiency are required; prior supervisory experience is preferred. On-site role with competitive compensation.

Qualifications

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

Responsibilities

• Select, manage, train, and develop staff; establish objectives and assignments; provide feedback.
• Manage scheduling of DHR Reviewers for coverage, prioritization and workload.
• Coordinate with internal customers to establish prioritizations and resolve 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.

Skills

Staff supervision

MS Office proficiency

Regulatory knowledge

Problem solving

Organizational skills

Education

Bachelor's degree

Job description

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.

What You’ll Work On

• 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

What You Contribute

• 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
• Prior supervisory experience preferred
• 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

Working Conditions

General office environment. Willingness and ability to work on site. Requires some lifting and moving of up to 25 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed.

Annual Base Salary Range: $75,000 - $100,000/ year

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

What We Offer

• 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).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.