Quality Engineer

5 days ago

Irvine, CA, United States Pacer Group Full time
Job Title: Sr Quality Engineer

Location: Irvine, CA 94404

Duration: 12 Months

Summary:
  • The main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation,Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.
Job Responsibilities:
  • Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
  • Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.
  • Lead Post Market Surveillance activities for products approved in EU.
  • Oversight of all complaints that require investigation through the different phases.
  • Ensure on time completion of complaints.
  • Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.
  • Ensure complaint investigations are adequate and comply with applicable procedures.
  • Develop, update, and maintain technical content of risk management files.
  • Other incidental duties assigned by Leadership.
Skills:
  • Proven expertise in usage of MS Office Suite including MS Project; Electronic Quality Management System.
  • Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
  • Basic understanding of statistical techniques.
  • Team player and detail oriented.
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
  • Strong problem-solving, organizational, analytical and critical thinking skills.
  • Substantial understanding of processes and equipment used in assigned work.
  • Good leadership skills and ability to influence change.
  • Knowledge of applicable FDA regulations for medical device industry.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast-paced environment.
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Education/Experience:
  • Bachelor's degree in engineering required.
  • 5-7 years experience required.

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