Senior Quality Engineer - Hybrid - San Francisco California

Company: CyberCoders
Location: San Francisco, California
Posted On: 05/19/2024

We are a leading Medical Device company located in Sunnyvale, CA, and are seeking a skilled Sr Quality Engineer to join the team! -
Position Overview:
We are looking for an experienced and detail-oriented Senior Quality Engineer to join our team. The Senior Quality Engineer will work closely with small teams of engineers to ensure the quality and safety of our products. The Senior Quality Engineer will be responsible for conducting quality checks, overseeing processes, and auditing product systems for compliance with regulatory standards. The ideal candidate should possess knowledge of and experience with eQMS systems, medical device regulations, and 21 CFR 820, ISO 13485, and ISO 14971. Additionally, knowledge of EU MDR, Master Control, Testing, Risk Analysis, Process Validation, CAPA, and NCR investigations would be a major plus.

Key Responsibilities:
-

• Develop and implement quality control systems to ensure compliance with applicable product standards
• Perform internal audits to ensure compliance with regulatory standards and guidelines
• Conduct risk analysis and generate reports for new products
• Review and approve product designs and specifications
• Identify process improvement opportunities and develop solutions to maximize efficiency and quality
• Investigate customer complaints and determine root causes for corrective action
• Perform process validations and document results
• Monitor and investigate NCRs and create CAPAs accordingly
• Collaborate with engineering and product teams to ensure quality requirements are met
  Qualifications:
  • Bachelor's degree in biomedical eng or equivalent -
  • 5+ years of professional experience as a Quality Engineer
  • Medical Device industry experience is a plus! -
  • Experience with eQMS systems, medical device regulations, and 21 CFR 820, ISO 13485, and ISO 14971
  • Knowledge of EU MDR, Master Control, Testing, Risk Analysis, Process Validation, CAPA, and NCR investigations
  • Excellent problem-solving, communication, and organizational skills
  • Ability to multitask and work in a fast-paced environmentPercentages of each part of the position:
    • Cybersecurity (5%)
    • SW Validation (15%)
    • Technical Complaint Investigation and CAPA determination (40%)
    • R&D Support / Design Transfer ( 40%)
    • 401K
    • PTO
    • Stock options -
    • Company perks and events -Applicants must be authorized to work in the U.S. South Plainfield, NJ Full-time $70,000.00 - $95,000.00 Job ID: AM23-1801349 Employees will receive paid leave to the extent required by state or local lawCyberCoders, Inc is proud to be an Equal Opportunity EmployerAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2024. CyberCoders, Inc. All rights reserved. CyberCoders is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email Benefits@cybercoders.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis. UnitedHealthcare creates and publishes the Transparency in Coverage -Machine-Readable Files -on behalf of CyberCoders.
      #J-18808-Ljbffr More...

          

      ---

      Register an account with us and set up job agents! We'll email you immediately when jobs like this are posted on our site.

      ---