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Quality Engineer III
Ref No.: 18-13444
Location: WEST IRVINE, California
Position Type:Engg
Start Date / End Date: 09/17/2018 to 12/31/2018
Job Title: Quality Engineer III
Duration: 3+ months
Location: West Irvine, CA- 92618
 
 
 
Job Description:
 
  • Oversight Quality Systems and Post Market Quality performance and metrics.
  • Drive standardization and simplification of performance reporting process including collection, trending, predictions and reporting of outcomes.
  • Convey issues/trends/opportunities for Quality System and Post Market Quality performance to Quality Management Representatives and process owners.
 
Principal Duties and Responsibilities:
 
  • Reporting on performance of quality system elements through creation of result summaries and data in support of Management Review.
  • Assure efficient and effective assembly of monthly and quarterly performance reporting and predictions for businesses.
  • Monitor key quality system performance metrics, communicate status and identify opportunities for metric improvements across the organization.
  • Provide leadership for special quality systems projects.
  • Provide direction on department audit findings and CAPA's.
  • Provide support to internal audit process. Serve as SME in responsible areas for internal and external audits.
  • Support and Influence Enterprise systems and standards related to areas of responsibility – training, management review, metrics
 
Education and/or Experience
 
  • B.S. in engineering, scientific, business or technical field
  • Minimum of 5 years experience in quality or compliance field
 
Other Skills and Abilities
 
  • Strategic thinker as it pertains to compliance programs with strong leadership ability, interpersonal, communication, and influencing skills.
  • Experience working in a matrixed environment.
  • Demonstrated compliance experience in domestic and international medical device and combination product quality systems.
  • Strong technical, planning, and execution capabilities.
  • Ability to analyze, balance, and prioritize risk.
  • Direct experience supporting FDA/Health Authority inspections.
 

Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331