Consultant, Quality Engineer, Medical Devices

Summary

Our client, a global medical device and diagnostic manufacturer, has engaged GForce Life Sciences to provide a Quality Engineer to assure quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards and Standards of the Medical Device Industry. The Quality Engineer will be responsible for supporting new product development and product maintenance using electromechanical knowledge and Quality Engineering Skills.

Job Duties

· Provide Quality engineering support to all assigned projects, manufacturing facilities and suppliers.

· Function as a Quality Representative on Design/Development and Manufacturing project teams.

· Assess current operations for quality and compliance.

· Develop & implement quality improvement programs.

· Ensure Design Control Elements are satisfied.

· Assist/conduct Failure Investigations and problem-solving sessions.

· Support and lead batch release activities.

· Lead complaints investigation. Review and approve commercial products.

Mandatory Requirements

· Bachelors degree in engineering or related field

· 3-5 years of experience in quality engineering

· Good understanding of Statistical Methods for Quality Assurance

· General working knowledge of the Six Sigma process methodology

· Experience in Risk management (ISO14971)

· Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards

Term & Start

· 6 month contract, opportunity to extend

· Opportunity for 100% Remote work

· Benefits available (Medical, Dental, Vision, 401k)