As a QA Manager of DHR Review, you will play a pivotal role in overseeing the team of Quality Specialists that performs Device History Record (DHR) review.
The QA Manager - DHR Review drives improvements and efficiencies in the area and ensures compliance with Penumbra procedures and regulatory requirements.
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.
• Lead, manage, and motivate a team performing DHR review activities while providing guidance, training, and support to ensure high performance and continuous development.
• Oversee the DHR review process to ensure compliance with applicable regulations and standards and internal quality policies.
• Communicate effectively both within area of responsibility and cross-functionally to ensure daily priorities are in alignment.
• Develop and maintain quality metrics for area of responsibility.
• Formulate and carry out company directives based on knowledge of the company's Quality Management System (QMS).
• Evaluate procedures for processing improvements, recommend changes to procedures and implement changes, as necessary.
• Participate in internal and external audits, including the retrieval of quality records and any other documentation requested, and represent DHR review processes.
• Provide additional analysis of situations reviewing various factors to solve problems and proactively seek and implement improvements.
What You Contribute
• A Bachelor's degree with 4+ years of experience in Quality Assurance, Quality Control, biotechnology, document control, or a related field, or equivalent combination of education and demonstrated experience
• Proficiency with Microsoft Office (e.g., Word, Excel, PowerPoint, etc.)
• Knowledge of global medical device regulations and standards including FDA and ISO 13485
• Demonstrated experience in managing and leading a team
• Strong analytical, problem solving, decision-making, and leadership skills are required
• High degree of accuracy and attention to detail
• Strong oral, written and interpersonal communication skills
Working Conditions
General office environment.
Willingness and ability to work on site.
Ability to travel up 25% of the time to other company sites as needed 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: $105,000 - $165,000 / 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 see Penumbra's AAP Policy Statement.