Medical Device Quality Engineer II – QA & Compliance

Penumbra, Inc.; San Francisco (CA); On-site; USD 95,000 - 127,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with employer match

Paid parental leave

Eleven paid company holidays

Accrued vacation (15+ days)

Job summary

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements ensuring high-quality medical devices conform to regulatory standards.

You will analyze problems of moderate scope, exercise judgment, and communicate quality objectives across teams. Responsibilities include collaboration on product qualification, PCB issue tracking, QA testing methodology, QC sampling, and internal audits.

Qualifications

• Associate’s or Bachelor's degree in Engineering, a Life Science, or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment, or equivalent combination of education and experience.
• Familiarity with QSR, ISO and other applicable regulations and laws required
• Familiarity with IEC 60601
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Experience with Electronic devices and or PCBAs
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint

Responsibilities

• Collaborate in the development and qualification activities for new and existing products
• Maintain and track critical hardware PCB issues, document findings, and ensure effective communication with relevant stakeholders
• Collaborate in the development of testing and inspection methodology and documentation for new and existing products
• 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 within the company, customers, and suppliers on quality related issues
• Collaborate in the development of standard operating procedures
• Facilitate and perform internal audits
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
• Ensure other members of the department follow the QMS, regulations, standards, and procedures
• Perform other work-related duties as assigned

Skills

Communication skills

MS Word, Excel, PowerPoint

Education

Engineering degree or related field

Job description

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements ensuring high-quality medical devices conform to regulatory standards.

You will analyze problems of moderate scope, exercise judgment, and communicate quality objectives across teams. Responsibilities include collaboration on product qualification, PCB issue tracking, QA testing methodology, QC sampling, and internal audits.