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Quality Engineer III

Permanente, CA 95014

Posted: 12/05/2024 Employment Type: Contract Job Category: Engineering Job Number: 615317 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 45-55/hr **salary will be commensurate with experience 

Job Description:


The Health Special Projects group is looking for a contract Design Quality Engineer to perform sustaining quality engineering activities, and support Quality management system efforts for its software medical device products.

Key Qualifications:

• 3+ years of medical device experience in a quality/regulatory role
• Familiarity with 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations
• Experience interpreting requirements and following standard operating procedures
• Experience with design control, and risk management activities for medical devices, including development and maintenance of design history files
• Exceptional organizational and management skills
• Excellent interpersonal skills, both verbal and written

Quality Engineers Are Responsible For:
  • Ensuring that Design Controls are properly executed in accordance to established standard operating procedures
  • Leading risk management activities in relation to new product development projects
  • Identifying and implementing effective systems to support products post market
  • Leading the execution of systems which identify and resolve quality issues (CAPAs)
  • Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Leading and implementing various product and process improvement methodologies
  • Leading the investigation, resolution and prevention of product and process nonconformances
  • Participating in new product development teams (represent the Quality function as a Core Team Member)
  • Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
  • Complying with applicable regulatory requirements, procedures, and processes, requirements
Additionally, cross-functional social skills and experience are essential to success in this role. This person will interact with various engineering design disciplines. You will be responsible for managing communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to cross functional teams.

Education & Experience:

B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline

Additional Requirements-
• Experience in working on software as a medical device (SaMD) products
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About Permanente, CA

Ready to embark on a thrilling career journey in vibrant Permanente, California? Nestled in the heart of Silicon Valley, this region boasts an exceptional blend of innovation and natural beauty, with job opportunities as enticing as the view from the top of nearby Mount Hamilton. From tech startups to renowned companies like Google and Apple, Permanente is a hotbed for professional growth in diverse industries. With the verdant trails of Rancho San Antonio County Park, the striking artworks at the Cantor Arts Center, and performances at the Mountain View Center for the Performing Arts, Permanente offers a rich tapestry of cultural experiences. Don't miss out on the chance to write the next chapter of your career story in this dynamic and enchanting location - explore our job listings today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.