You're using an older version of Internet Explorer that is no longer supported. Please update your browser.
You're using an older version of Internet Explorer and some functionality may not work as expected. Please update your browser for the best experience.

Quality Assurance Investigator – Burnaby, BC

Category:
Quality Assurance
Type:
Full Time
Location:
Burnaby, BC     

Share job:



LivaNova is a global medical device company and a leader in the treatment of cardiac surgery, neuromodulation and cardiac Rhythm Management. We are an organization of growth and change. As such, we seek exceptional talent to propel our company forward and continue our tradition of innovation and excellence in everything we do.

 

The successful candidate will conduct investigations to determine root cause for the incidences.  Support all correction and removal to the FDA and/or World Wide Competent Authorities.  Prepares reports and maintains documentation in accordance with implemented quality programs and policies. In addition, the successful candidate will be responsible for the following:

 

Essential Functions:

 

  • Evaluate, investigate, track and complete complaint investigations
  • Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
  • Participate and collaborate objectively with productive conclusions in the complaint handling meetings.
  • Collaborate with Research and Development, Sales and Marketing, Clinical, and other appropriate departments for adequate initial evaluation and investigation of complaints.
  • Collaborate with the QA team to submit reportable complaints and assist in the activities for Correction and Removal process.
  • Monitors guidelines, collect process and quality data to determine trends and identify potential risks
  • Perform scheduled quality system audits for compliance to written controlled procedures and prepare thorough audit reports.
  • Assist in the development of tests and test plans with guidance from Quality Assurance Engineering. 
  • Lead and/or participate in CAPA and Problem Investigations by obtaining, analyzing, and documenting production and Quality Control data
  • Conducts audits to assure adherence to in-house and/or external specifications and standards, such ISO 9001/13485 and applicable medical device regulations.

Further requirements:

 

  • Bachelor Degree or higher in scientific, health care, nursing or related field, or relevant years work experience
  • 2-5 years experience in Quality Assurance, Complaint handling, in a regulated industry.
  • Knowledgeable in quality management and quality control systems and regulatory requirements.
  • Have general knowledge of product manufacturing, inspections, and assembly.
  • Have basic capabilities of reading and interpreting engineering drawings

Posted: February 23, 2017
Closes:April 24, 2017
Email Address:
Company Info
Industry:
Technology

Connect with employer:

About LivaNova

Joining our team is a rewarding experience.

We’re known across the globe as a company that delivers life-saving innovation, embraces change and adapts quickly. Staying ahead of a fast-pa...

vm