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Engineer II (Quality/Post Market Surveillance)

Job Description

Job Req #: 19-06400
Job Description: Post Market Surveillance Quality Engineer II
Location:  Irvine, CA
Position Type: 6+ Months
 
Position Summary:
The Post Market Surveillance Quality Engineer II 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, Client and SCAR review and changes to relevant standards and regulations.

Key Responsibilities:
  • 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
  • Must have experience in medical device industry

Qualifications:
  • A Bachelor’s Degree or equivalent in Engineering field with a minimum of three (3) years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.
  • Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
  • 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 Edwards 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
Brierly Lindberg
Recruiter
Ascent
blindberg@ascentsg.com
925-627-4329

Job Requirements

 

Job Snapshot

Location US-CA-Irvine
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Engineering & Aerospace
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-CA-Irvine
Brierly Lindberg
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Snapshot
Ascent
Company:
US-CA-Irvine
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description

Job Req #: 19-06400
Job Description: Post Market Surveillance Quality Engineer II
Location:  Irvine, CA
Position Type: 6+ Months
 
Position Summary:
The Post Market Surveillance Quality Engineer II 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, Client and SCAR review and changes to relevant standards and regulations.

Key Responsibilities:
  • 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
  • Must have experience in medical device industry

Qualifications:
  • A Bachelor’s Degree or equivalent in Engineering field with a minimum of three (3) years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.
  • Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
  • 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 Edwards 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
Brierly Lindberg
Recruiter
Ascent
blindberg@ascentsg.com
925-627-4329

Job Requirements

 
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Engineer II (Quality/Post Market Surveillance) Apply now