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QA Supervisor - DHR Review

PenumbraRoseville, CA

$71,000 - $98,000 / year

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Overview

Schedule
Full-time
Career level
Senior-level
Remote
On-site
Compensation
$71,000-$98,000/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance

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:  $71,000 - $98,000 / 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, 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).
    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 seePenumbra's AAP Policy Statement.

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    FAQs About QA Supervisor - DHR Review Jobs at Penumbra

    What is the work location for this position at Penumbra?
    This job at Penumbra is located in Roseville, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
    What pay range can candidates expect for this role at Penumbra?
    Candidates can expect a pay range of $71,000 and $98,000 per year.
    What employment applies to this position at Penumbra?
    Penumbra lists this role as a Full-time position.
    What experience level is required for this role at Penumbra?
    Penumbra is looking for a candidate with "Senior-level" experience level.
    What is the process to apply for this position at Penumbra?
    You can apply for this role at Penumbra either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.