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Engineer I (Quality / Post Market Surveillance)

Date Posted: 2/8/2019

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Job Description

A Global Medical Device company in Irvine, CA is looking to add an Engineer I to their team!
Job Purpose:

  • The Post Market Surveillance Quality Engineer I will provide engineering support for PMS system to collect and perform trend analysis assessing the following data sources on products: adverse events, complaints, product feedback, customer requirements and market needs, patient follow-up after clinical trials/investigations, service reports, scientific papers in peer-reviewed journals, reports on similar products by competitors, Field Corrective Action, CAPA, NCR and SCAR review and changes to relevant standards and regulations. This PMS Quality Engineer will also be focused on activities associated with the implementation of the EU Medical Device Regulation (MDR) Program
Essential Job Functions:
  • This would include usability engineering plan, review of and evaluation of historical data and summative evaluation plan
  • Conduct and support the Post-Market Surveillance activities to ensure compliance to EU Medical Device Regulation (MDR) requirements
  • Provide quality engineering expertise in the areas of Risk Management, Design Controls, Usability Engineering, Quality Assurance/Control, Regulatory Compliance, and Statistical Techniques, as needed
  • Ensure compliance with all Federal, State, local and company regulations, policies and procedures
  • Highly organized and drive project plans per timeline
  • Ability to effectively analyzing data and report data with large datasets is required
  • Effective communication and presentation skills
  • Strong statistical analysis skills using Excel
 
Skills:
  • Proven expertise in MS Office Suite and ability to operate general office machinery
  • Excellent written and verbal communication skills and interpersonal relationship skills
  • Demonstrated problem-solving, critical thinking, and investigative skills
  • Full knowledge and understanding of company policies, procedures, and guidelines relevant to quality compliance
  • Good knowledge of medical terms and human anatomy
  • Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
  • Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
  • Ability to manage confidential information with discretion
  • Attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Work is performed independently on complex work and reviewed for accuracy and soundness
Education & Experience:
  • Bachelor's degree or equivalent in engineering field with a minimum of 1-2 years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries
  • Must have experience in medical device industry (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment
  • CAPA Certification


We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Job Requirements

A Global Medical Device company in Irvine, CA is looking to add an Engineer I to their team!
Job Purpose:
The Post Market Surveillance Quality Engineer I will provide engineering support for PMS system to collect and perform trend analysis assessing the following data sources on products: adverse events, complaints, product feedback, customer requirements and market needs, patient follow-up after clinical trials/investigations, service reports, scientific papers in peer-reviewed journals, reports on similar products by competitors, Field Corrective Action, CAPA, NCR and SCAR review and changes to relevant standards and regulations. This PMS Quality Engineer will also be focused on activities associated with the implementation of the EU Medical Device Regulation (MDR) Program
Essential Job Functions:
This would include usability engineering plan, review of and evaluation of historical data and summative evaluation plan
Conduct and support the Post-Market Surveillance activities to ensure compliance to EU Medical Device Regulation (MDR) requirements
Provide quality engineering expertise in the areas of Risk Management, Design Controls, Usability Engineering, Quality Assurance/Control, Regulatory Compliance, and Statistical Techniques, as needed
Ensure compliance with all Federal, State, local and company regulations, policies and procedures
Highly organized and drive project plans per timeline
Ability to effectively analyzing data and report data with large datasets is required
Effective communication and presentation skills
Strong statistical analysis skills using Excel
 
Skills:
Proven expertise in MS Office Suite and ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship skills
Demonstrated problem-solving, critical thinking, and investigative skills
Full knowledge and understanding of company policies, procedures, and guidelines relevant to quality compliance
Good knowledge of medical terms and human anatomy
Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Ability to manage confidential information with discretion
Attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Work is performed independently on complex work and reviewed for accuracy and soundness
Education & Experience:
Bachelor's degree or equivalent in engineering field with a minimum of 1-2 years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries
Must have experience in medical device industry (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment
CAPA Certification
Posted By: jchang@ultimatestaffing.com

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Engineering
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:2/8/2019
  • Contact: Joshua Chang (949) 265-6070
  • Pay Range: $22.00 - $27.59 Hourly
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Job Reference: JO-1902-50334