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Sr Quality Engineer
Temecula, California
Contract Position
It appears that you have already applied to this job.
Applied on March 7, 2021
Job Id #45278 Posted January 22, 2021


MAIN PURPOSE OF ROLE Summarize the main purpose of the role.

  • Quality Risk Management Team member responsible for providing Risk Management quality engineering support within new product development, manufacturing, or system/services. 

MAIN RESPONSIBILITIES

  • Own creation and updates of Risk Management Files.
  • Participate in  teams in supporting quality disciplines, decisions, and practices for risk management.
  • Resolves project issues by working with team members, project customers, and others as appropriate.
  • Interfaces with management and cross functional teams on significant matters, often requiring the coordination of activity across organizational units.
  • Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments
QUALIFICATIONS 
  • Education Level
    • Bachelors Degree (± 16 years)    
  • Major/Field of Study    
    • Engineering or Technical Field  
  •  Education Level
    • An equivalent combination of education and work experience
Experience/Background
  • Minimum 5 years    
  • Engineering experience and demonstrated use of Quality tools/methodologies.
  • Knowledge of FDA, GMP, ISO 13485, and ISO 14971.  
  • Solid communication and interpersonal skills.
  • Strong project management skills, including the demonstrated ability to lead multi-departmental project assignments and resolve quality-related issues in a timely and effective manner 
  • Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience preferred.  
  • Experience with risk management (ISO 14971) is preferred. 
  • Knowledge of devices used for PTCA and PTA is desirable.  
  • Knowledge of various tools and techniques for Risk Management is desirable. 

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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