Quality Engineer II - Design Assurance

Company: Freudenberg Group
Location: Carpinteria
Posted on: March 16, 2023

Job Description:

Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments. The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.

At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,000 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.

You support our team as

Quality Engineer II - Design Assurance


Responsibilities

• 
  
• Perform Quality Engineering tasks associated with Design & Development activities:
  
• review/approve Design Control documentation (e.g. Design Verification, Process or component validation)
  
• participate in Test Method validation activities associated with Design Verification activities
  
• represent Quality in NPD project team meetings & Design Reviews
  
• prepare and release Inspection Plans and Quality Control Inspection Criteria (QCICs)
  
• support qualification of purchased components
  
• audit D&D activities to ensure compliance with procedures and standards
  
• 
  
• Lead Risk Management activities for new or legacy products (RMP, Risk Analysis, RMR).
  
• Lead complaints analysis investigations and trend reporting for IHT products.
  
• Analyze internal and external quality product performance and address non-conformities.
  
• Represent Quality engineering in Engineering Change Order process for IHT products.
  
• Lead elements of the Quality System as necessary.
  
• Participate in both Internal and/or External audits.
  
• Follow safe systems of work, taking care of personal health and safety and that of others, along with environmental awareness for the site and community. Eliminating or reducing risks where practicable by complying with site safety rules and instructions and reporting hazards to management for prompt action.
  
• Drive and embrace the continuous improvement system and culture created by Freudenberg.
  
• Onsite or Hybrid (minimum 3 days per week in the Carpinteria, CA office, contingent on business need with 1 to 2 days per week working from a home office).
  
  
  
  
  
  Qualifications
  
  
  
  • 
    
  • Bachelor's Degree in engineering, Sciences or related discipline.
    
  • 5+ years of experience in a regulated industry (e.g., medical or pharma products).
    
  • Demonstrated experience with Quality System Tools (Control Plan, MSA, SPC, etc.).
    
  • Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
    
  • Statistics and statistical analysis software (e.g. Minitab)
    
  • Demonstrated experience with Risk Management (ISO 14971)
    
  • Design Controls (21CFR 820)
    
  • ISO 13485
    
  • Experience with GD&T and fixturing is preferred
    
  • Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team
    
  • Outstanding written and verbal communication skills
    
  • Keen ability to prioritize work and execute
    
  • Strong organizational skills; strong technical/computer skills
    
  • Ability to travel as required (minimal).
    
    
    
    

Keywords: Freudenberg Group, Santa Barbara , Quality Engineer II - Design Assurance, Engineering , Carpinteria, California