Previous Job
Previous
Quality Engineer III
Ref No.: 18-03728
Location: Shoreview, Minnesota
Start Date / End Date: 06/04/2018 to 05/31/2019
Description:
JOB DESCRIPTION – ENGINEER, QUALITY SYSTEMS AND INTEGRATION

Responsibilities:
This position will assist with day to day execution, and integration, of a newly acquired medical device company with the new parent company.

This person will provide leadership and project management skills to plan, organize, and execute activities required to ensure the newly acquired company meets the quality system requirements of both federal and regulatory standards, as well as corporate procedures

This person will help to integrate the quality system procedures, processes, and systems between the acquired company and the parent company.

This person will collaborate with cross-functional teams to support the overall integration effort.

This person will communicate progress of quality integration efforts and quality system compliance risks.

Perform gap assessments between the two quality systems and ensure timely corrective and preventive actions to address any remediation efforts that are required as the result of gaps found.

Support internal and external audits

Support day to day execution of CAPA and Non-Conformance processes.

Support day to day document control management

Support day to day training system execution

Other responsibilities may be assigned and not all responsibilities listed may be assigned.


Job Qualifications:
• A BS Degree in technical science or engineering or BA in business, quality is required.
• A minimum of 4 years of related experience is required, preferably in a regulated industry
• Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software
• Experience in audits (either as auditor or auditee) to ISO standards for QMS, MDD, FDA QSR and CMDR, required.
• Experience with quality systems is required.
• Experience in the management of document control, CAPA, Non-Conformance, and training processes preferred
• General knowledge of medical devices regulatory requirements is necessary. Experience in the medical devices or pharmaceutical industry is preferred. Possess a demonstrated track record of achieving successful compliance.
• Proven success in: Accountability, with a strong desire to commit, and be held accountable for delivering results.
• Must have strong collaboration skills to partner effectively with Operating Company functions and across Operating Units. Proven track record of demonstrating collaboration across organizations at multiple levels
• Strong analytical skills and experience
• Change management and project management experience
• Communication – demonstrate the ability to discuss complex quality issues and concepts in a clear and concise manner, orally and in writing - with all levels of management
• Detail oriented
Bring Your Own Device (BYOD)
Yes
Will this position require the handling of a controlled substance?
No
Hours per Day 8
Hours per Week 40
Total Hours 2,080.00

Attachments

Job Description: Engineer, Quality Systems and Integration


Responsibilities:

This position will assist with day to day execution, and integration, of a newly acquired medical device company with the new parent company.

This person will provide leadership and project management skills to plan, organize, and execute activities required to ensure the newly acquired company meets the quality system requirements of both federal and regulatory standards, as well as corporate procedures

This person will help to integrate the quality system procedures, processes, and systems between the acquired company and the parent company.

This person will collaborate with cross-functional teams to support the overall integration effort.

This person will communicate progress of quality integration efforts and quality system compliance risks.

Perform gap assessments between the two quality systems and ensure timely corrective and preventive actions to address any remediation efforts that are required as the result of gaps found.

Support internal and external audits

Support day to day execution of CAPA and NonConformance processes.

Support day to day document control management

Support day to day training system execution

Other responsibilities may be assigned and not all responsibilities listed may be assigned.


Job Qualifications:
  • A BS Degree in technical science or engineering or BA in business, quality is required.
  • A minimum of 4 years of related experience is required, preferably in a regulated industry
  • Personal computer skills, Windows: word processing, project planning, presentation, e-mail and spreadsheet software
  • Experience in audits (either as auditor or auditee) to ISO standards for QMS, MDD, FDA QSR and CMDR, required.
  • Experience with quality systems is required.
  • Experience in the management of document control, CAPA, NonConformance, and training processes preffered
  • General knowledge of medical devices regulatory requirements is necessary. Experience in the medical devices or pharmaceutical industry is preferred. Possess a demonstrated track record of achieving successful compliance.
  • Proven success in: Accountability, with a strong desire to commit, and be held accountable for delivering results.
  • Must have strong collaboration skills to partner effectively with Operating Company functions and across Operating Units. Proven track record of demonstrating collaboration across organizations at multiple levels
  • Strong analytical skills and experience
  • Change management and project management experience
  • Communication – demonstrate the ability to discuss complex quality issues and concepts in a clear and concise manner, orally and in writing - with all levels of management
  • Detail oriented