Quality Assurance Manager

4 weeks ago

Oakland, California, United States Penumbra Full time
Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Penumbra, Inc. in Alameda, California. As a key member of our quality team, you will play a pivotal role in overseeing the Device History Record (DHR) review process and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Lead and manage a team of Quality Specialists performing DHR review activities, 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, including FDA and ISO 13485.
  • Develop and maintain quality metrics for the area of responsibility, formulating and carrying out company directives based on knowledge of the Quality Management System (QMS).
  • Participate in internal and external audits, including the retrieval of quality records and documentation, and represent DHR review processes.
  • Provide additional analysis of situations, reviewing various factors to solve problems and proactively seek and implement improvements.
Requirements
  • 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, with strong analytical, problem-solving, decision-making, and leadership skills.
  • High degree of accuracy and attention to detail, with strong oral, written, and interpersonal communication skills.
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, including 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).
About Penumbra

Penumbra, Inc. is a global healthcare company focused on innovative therapies. We design, develop, manufacture, and market novel products that address challenging medical conditions in markets with significant unmet need. Our products are sold to hospitals and healthcare providers primarily through our direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets.

We are an equal opportunity employer and welcome applications from qualified candidates 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.

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