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Senior Quality Engineer for Medical Devices

Senior Quality Engineer for Medical Devices

PenumbraRoseville, CA, United States
4 days ago
Job type
  • Full-time
Job description

General Summary

Join Penumbra as a Senior Quality Engineer, where your expertise will be essential in supporting process development, supplier enhancement, and manufacturing excellence. Your critical eye for detail will help ensure top-tier quality in both new and existing products, while you navigate regulatory compliance. You'll foster a culture of quality across the organization through clear communication of quality objectives.

What You'll Work On

  • Represent Quality Engineering in cross-functional teams, collaborating with Manufacturing, QC, R&D, Regulatory Affairs, Operations, and Marketing.
  • Continuously evaluate, analyze, and enhance manufacturing processes, quality controls, and engineering systems for your assigned product lines.
  • Manage Engineering Change Orders for designated projects and product lines.
  • Design and implement effective testing and inspection methods to meet product quality control standards.
  • Build strong partnerships with suppliers to improve technical processes and ensure adherence to Penumbra's quality standards.
  • Lead risk analysis initiatives and documentation efforts.
  • Coordinate quality efforts on project teams to achieve project objectives.
  • Plan and execute engineering projects to align with business and quality goals.
  • Provide leadership to ensure compliance with quality systems and regulations for your projects and products.
  • Oversee investigations of nonconforming reports and recommend corrective actions.
  • Initiate, implement, and close Corrective Action Preventative Actions (CAPA).
  • Design experiments, apply statistical analysis, and interpret engineering test data.
  • Mentor junior staff and possibly supervise their work.

Position Qualifications

  • Education and Experience : Bachelor's degree in Engineering, Life Science, or related field with 5+ years of relevant experience in Quality Assurance, including ISO experience.
  • Additional Qualifications : Advanced degree preferred. Desired experience in auditing, design review, sterilization, project management, or product development.

    • What You'll Bring

  • A strong analytical mindset focused on problem-solving.
  • Abilities to effectively tackle quality control challenges.
  • Team-oriented with enthusiasm for working in cross-functional technical environments.
  • Excellent oral and written communication skills.
  • Adaptability and flexibility to thrive amidst changing priorities.
  • Thorough knowledge of relevant regulations and standards (e.g., QSR, ISO 13485).
  • Familiarity with sterilization, biocompatibility, and shelf-life standards.
  • Proficient in data collection, analysis, and scientific methods.
  • Experience in R&D or new product development is a plus.
  • ASQ CQE certification preferred.

    • Working Conditions

  • Office, laboratory, and cleanroom environments.
  • Business travel expected to be 0% - 10%.
  • Exposure to blood-borne pathogens may occur.
  • Ability to lift up to 25 pounds.
  • Mobility across multiple buildings and floors is required.
  • Capacity to remain stationary and operate standard office equipment for extended periods.
  • Competence in reading, preparing emails, and producing documents and reports.
  • Ability to communicate effectively with staff at all levels.

    • Location and Salary :

    Roseville, CA. Starting Base Salary : $113,000 / year - $157,000 / year. Individual compensation may vary based on performance, skills, competencies, and location.

    What We Offer

    Become part of a collaborative team where continuous learning is valued and performance is recognized. Join us in revolutionizing the treatment of significant medical conditions. Our benefits package includes medical, dental, vision, life insurance, 401(k) with employer match, stock purchase plan, paid parental leave, eleven paid holidays, a minimum of fifteen days of vacation per year, and paid sick leave, compliant with legal requirements.

    Penumbra, Inc., based in Alameda, California, is dedicated to innovative healthcare solutions. We design and develop groundbreaking products targeting medical needs with significant gaps in treatment options. Our products are marketed primarily to healthcare providers and hospitals through our direct sales teams in the United States and various international markets.

    We celebrate diversity and are committed to providing equal employment opportunities as outlined in federal, state, and local laws.

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    Quality Engineer • Roseville, CA, United States