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Quality Engineer

In United States

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Quality Engineer   

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JOB TITLE:

Quality Engineer

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

North Chicago, IL United States

JOB DESCRIPTION:

Position Name: Quality Engineer

Location: North Chicago, IL

Duration: Long term

Hiring Mode:-C2C

Need Post Market Surveillance exp…

 

Job Description:

The Quality Engineer works within the Divisional Post Market Surveillance team which supports and guides the Business Units in discharging their regulatory obligations to conduct Complaint Handling, Vigilance reporting and Post Market Surveillance activities.

Responsibilities and Duties

  • Contributes as part of a geographically dispersed team of quality and data analysis professionals that constitute the Divisional Post Market Surveillance team.
  • Possesses and applies comprehensive knowledge of Quality, and its application to the field of Complaint Handling, Vigilance Reporting and Post Market Surveillance.
  • Support Global Business Units in executing on Complaint Handling, Vigilance Reporting and Post Market Surveillance activities to meet corporate and regulatory timelines
  • Obtain a thorough knowledge of ARDxs global operations and structures in order to enable informed decisions and to provide direction to BU Quality and Regulatory teams and other functional areas.
  • Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
  • Drives compliance cross functionally in alignment with the divisional for collaboration and multi-site adherence to relevant regulatory requirements.
  • Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances.
  • Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.
  • Drives business improvements through continuous improvement initiatives.
  • Responsibility for delivery of projects on behalf of the Division and with the support of the Business Units
  • Escalation point for quality related non-conformances and CAPAs.

Requirements

Qualifications (essential):

  • Third Level Qualification in related field (Science, engineering or nursing preferable)
  • Minimum 8 years of experience in medical device industry with minimum 3 years of progressively responsible positions, including;
    • Experience with Post market Surveillance, both active and passive, including the generation of periodic reports.
    • Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
  • Experience working in electronic complaint management systems
  • Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.
  • Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
  • Excellent computer skills including all MS Office applications
  • Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
  • Able to travel internationally (approximately 15% annually)

 

Qualifications (preferred):

  • Experience supporting in-vitro diagnostics products
  • Experience managing customer complaints for medical device or in-vitro diagnostics
  • Broad knowledge of engineering and technical applications applied in development of medical devices useful

 

Surjeet

TalentmoversInc.

M- +1 (703) 993-0200

Email-surjeet@talentmoversinc.com

Position Details

POSTED:

Oct 06, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16549056548876168

LOCATION:

United States

CITY:

North Chicago, IL

Job Origin:

OORWIN_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Quality Engineer    Apply

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<p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b>Position Name: Quality Engineer</b></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b>Location: North Chicago, IL</b></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b>Duration: Long term</b></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b>Hiring Mode:-C2C</b></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b><span lang="EN-GB" style="font-size:10.0pt"><span style="background:yellow">Need Post Market Surveillance exp…</span></span></b></span></span></p> <p> </p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b><span lang="EN-GB" style="font-size:10.0pt">Job Description:</span></b></span></span></p> <p style="margin-bottom:8px"><span style="font-size:11pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif">The Quality Engineer works within the Divisional <span style="background:yellow">Post Market Surveillance</span> team which supports and guides the Business Units in discharging their regulatory obligations to conduct Complaint Handling, Vigilance reporting and Post Market Surveillance activities. </span></span></span></p> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b>Responsibilities and Duties</b></span></span></p> <ul> <li class="Default"><span style="font-size:12pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="font-family:Arial,sans-serif"><span style="color:black"><span style="font-size:11.0pt"><span style="line-height:115%"><span style="font-family:"Calibri",sans-serif">Contributes as part of a geographically dispersed team of quality and data analysis professionals that constitute the </span></span></span><span lang="EN-IE" style="font-size:11.0pt"><span style="line-height:115%"><span style="font-family:"Calibri",sans-serif">Divisional Post Market Surveillance team. </span></span></span></span></span></span></span></span></li> <li class="Default"><span style="font-size:12pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="font-family:Arial,sans-serif"><span style="color:black"><span style="font-size:11.0pt"><span style="line-height:115%"><span style="font-family:"Calibri",sans-serif">Possesses and applies comprehensive knowledge of Quality, and its application to the field of Complaint Handling, Vigilance Reporting and Post Market Surveillance.</span></span></span></span></span></span></span></span></li> <li class="Default"><span style="font-size:12pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="font-family:Arial,sans-serif"><span style="color:black"><span style="font-size:11.0pt"><span style="line-height:115%"><span style="font-family:"Calibri",sans-serif">Support Global Business Units in executing on Complaint Handling, Vigilance Reporting and Post Market Surveillance activities to meet corporate and regulatory timelines</span></span></span></span></span></span></span></span></li> <li class="Default"><span style="font-size:12pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="font-family:Arial,sans-serif"><span style="color:black"><span style="font-size:11.0pt"><span style="line-height:115%"><span style="font-family:"Calibri",sans-serif">Obtain a thorough knowledge of ARDxs global operations and structures in order to enable informed decisions and to provide direction to BU Quality and Regulatory teams and other functional areas.</span></span></span></span></span></span></span></span></li> <li style="text-align:justify"><span style="font-size:11pt"><span style="tab-stops:list .25in"><span style="text-autospace:none"><span style="font-family:Calibri,sans-serif">Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, more complex, less clearly defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.</span></span></span></span></li> <li><span style="font-size:11pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Drives compliance cross functionally in alignment with the divisional for collaboration and multi-site adherence to relevant regulatory requirements.</span></span></span></span></span></li> <li style="text-align:justify"><span style="font-size:11pt"><span style="tab-stops:list .25in"><span style="text-autospace:none"><span style="font-family:Calibri,sans-serif">Seeks consensus for decisions under conditions of uncertainty, sometimes with incomplete information, in order to produce effective end results. Applies risk assessment techniques in such circumstances. </span></span></span></span></li> <li><span style="font-size:12pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="font-family:"Times New Roman",serif"><span lang="EN-GB" style="font-size:11.0pt"><span style="line-height:115%"><span style="font-family:"Calibri",sans-serif">Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions. </span></span></span></span></span></span></span></li> <li style="text-align:justify"><span style="font-size:11pt"><span style="tab-stops:list .25in"><span style="text-autospace:none"><span style="font-family:Calibri,sans-serif">Drives business improvements through continuous improvement initiatives.</span></span></span></span></li> <li class="Default"><span style="font-size:12pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="font-family:Arial,sans-serif"><span style="color:black"><span style="font-size:11.0pt"><span style="line-height:115%"><span style="font-family:"Calibri",sans-serif">Responsibility for delivery of projects on behalf of the Division and with the support of the Business Units</span></span></span></span></span></span></span></span></li> <li><span style="font-size:11pt"><span style="line-height:115%"><span style="tab-stops:list .25in"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Escalation point for quality related non-conformances and CAPAs.</span></span></span></span></span></li> </ul> <p style="text-align:justify"><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><b>Requirements</b></span></span></p> <p class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Qualifications (essential): </span></span></span></span></span></p> <ul> <li class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Third Level Qualification in related field (Science, engineering or nursing preferable) </span></span></span></span></span></li> <li><span style="font-size:11pt"><span style="color:black"><span style="line-height:115%"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Minimum 8 years of experience in medical device industry with minimum 3 years of progressively responsible positions, including; </span></span></span></span></span> <ul style="list-style-type:circle"> <li><span style="font-size:11pt"><span style="color:black"><span style="line-height:115%"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Experience with Post market Surveillance, both active and passive, including the generation of periodic reports.</span></span></span></span></span></li> <li><span style="font-size:11pt"><span style="color:black"><span style="line-height:115%"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP) </span></span></span></span></span></li> </ul> </li> <li class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Experience working in electronic complaint management systems </span></span></span></span></span></li> <li><span style="font-size:11pt"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness. </span></span></span></li> <li><span style="font-size:11pt"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time. </span></span></span></li> <li><span style="font-size:11pt"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Excellent computer skills including all MS Office applications</span></span></span></li> <li><span style="font-size:11pt"><span style="text-autospace:ideograph-other"><span style="font-family:Calibri,sans-serif">Proficient with MS Word, Excel, Power Point, and management of spreadsheets.</span></span></span></li> <li class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Able to travel internationally (approximately 15% annually) </span></span></span></span></span></li> </ul> <p class="Default"> </p> <p class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><b><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Qualifications (preferred): </span></span></b></span></span></span></p> <ul> <li class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Experience supporting in-vitro diagnostics products </span></span></span></span></span></li> <li class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Experience managing customer complaints for medical device or in-vitro diagnostics</span></span></span></span></span></li> <li class="Default"><span style="font-size:12pt"><span style="font-family:Arial,sans-serif"><span style="color:black"><span lang="EN-IE" style="font-size:11.0pt"><span style="font-family:"Calibri",sans-serif">Broad knowledge of engineering and technical applications applied in development of medical devices useful</span></span></span></span></span></li> </ul> <p class="Default"> </p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="color:black">Surjeet</span></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="background:white"><span style="color:black">TalentmoversInc. </span></span></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span lang="EN-IN" style="color:black">M- +1 (</span>703<span lang="EN-IN" style="color:black">) </span>993<span lang="EN-IN" style="color:black">-</span>0200</span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="color:black">Email-surjeet@talentmoversinc.com</span></span></span></p>


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