Quality Engineer II — Med Device QC & Process Improvement

Penumbra, Inc.; Roseville (CA); In loco; USD 85.000 - 114.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision

401(k) with employer match

Paid holidays

Vacation days

Paid sick time

Descrizione del lavoro

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements, ensuring product quality and regulatory compliance. The role involves collaboration across teams to create testing methods, QC processes, and SOPs, while performing internal audits and ensuring adherence to QMS and regulatory standards.

Strong communication and familiarity with QSR/ISO are required. The position is based in Roseville, CA, with an annual base salary and comprehensive benefits.

Competenze

• 2+ years of quality engineering or relevant experience, preferably in a medical devices environment
• Familiarity with QSR, ISO and other applicable regulations and laws
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint

Mansioni

• Collaborate in development and qualification activities for new and existing products
• Collaborate in development of testing and inspection methodology and documentation
• Collaborate on Quality Objective teams
• Design and install QC process sampling systems, procedures, and statistical techniques
• Design or specify inspection and testing mechanisms and equipment
• Perform failure analyses and defect investigations
• Analyze production limitations and standards
• Recommend revision of specifications
• Interface with other engineering departments, customers, and suppliers on quality issues
• Collaborate in development of standard operating procedures
• Facilitate and perform internal audits
• Adhere to the company’s QMS and applicable regs and procedures
• Understand security, privacy and compliance principles and adhere to applicable regs
• Ensure other members of the department follow QMS etc
• Perform other work-related duties as assigned

Conoscenze

Communication

Regulatory knowledge

Formazione

Associate’s degree in Engineering or related field

Bachelor’s degree in Engineering or Life Science or related field

Strumenti

MS Word

MS Excel

PowerPoint

Descrizione del lavoro

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements, ensuring product quality and regulatory compliance. The role involves collaboration across teams to create testing methods, QC processes, and SOPs, while performing internal audits and ensuring adherence to QMS and regulatory standards.

Strong communication and familiarity with QSR/ISO are required. The position is based in Roseville, CA, with an annual base salary and comprehensive benefits.