Quality Systems Manager

LGTmedical Technologies

August 27, 2014

Original postings on the Viatec site are removed after the position is closed, but the posting will be archived here. The original posting was at
http://www.viatec.ca/job-board/12174

Job Category: 
Technical
Job Specialization: 
Engineering
Job
Company Overview: 

Founded in 2012, LGTmedical is a Vancouver-based technology company tackling the mobile health market. Using a proprietary connectivity technology, LGTmedical connects low-cost medical sensors – such as a pulse oximeter sensor, blood pressure cuff, or temperature sensor - to the audio port of mobile phones, laptops, tablets, and PCs. By replacing most of the conventional hardware with software running on a mobile general- purpose computing platform, we offer a first-of-its-kind software-defined medical app-device solution. This technology has the potential to save millions of lives globally and billions of dollars in the developed world.

Job Summary: 

The QSM is responsible for ensuring that all managers, process owners and supervisors help develop and maintain their part of the quality management system. The QSM oversees documentation efforts to ensure compliance with relevant regulations and standards; and manages activities such as audits, regulatory agency inspections, or product recalls.

Responsibilities:

  • Manages and maintains the corporate quality system compliant with ISO 13485 and FDA GMP.
  • Works with stakeholders to develop and evolve procedures and standards of practice for each primary area and job responsibility.
  • Trains staff and consultants on relevant procedures.
  • Maintains records training records.
  • Conducts internal audits.
  • Functions as the compliance officer.
  • Acts as primary liaison for all quality related issues.
  • Develops audit plans.
  • Presents and defends the quality system to appropriate external auditors.
  • Assists in compiling filings for FDA 510(k), Europe (CE Technical File), Health Canada application, Asia, Africa and others countries as needed.
  • Investigates product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Carries out other related duties and projects as required

Qualifications:

  • BSc in Electrical Engineering, Biomedical Engineering, Computer Science, Health Information Science, or related discipline with 10 years regulatory compliance experience as pertains to a medical device under ISO 13485, FDA GMP and Health Canada; or equivalent Technical certifications plus 10 years of regulatory compliance experience.
  • Extensive experience with controlled documents, SOP processes and procedures, change control and CAPA systems
  • Experience with the implementation, maintenance, and management of Quality Systems
  • Certified to perform quality system audits
  • Experience with training
  • Understanding of software and hardware development lifecycles
  • Commitment to quality processes and controls
  • Strong teamwork skills, excellent written and verbal communication skills
  • Excellent problem solving skills
  • Detailed with a focus on documentation and evidence.
  • Ability to work independently.
How To Apply: 

Please send your cover letter and resume (PDF, plain text, MS Word or html) to HR@LGTmedical.com. Applications must have QSM-VIATEC in the subject line.