Quality Assurance Lead

Responsibilities

Lead Change Control Committee in the evaluations of Change Proposals to assure appropriateness

Provide training and mentorship to change initiators in assuring Change Proposals address requirements for change implementation

Compile and analyze change control information required for Management Review, and other business needs, and prepare associated reports and/or presentation slides

Determines need for Change Control Effectiveness Checks and Performs review/close out of Effectiveness Checks

Performs review of change controls and final approval for implementation of changes

Generating, implementing and/or reviewing completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Reviewing and providing quality oversight of results of validation activities

Reviewing the results of testing and determining the acceptability of results against pre-determined criteria

Investigating and troubleshooting problems and providing recommendations for changes and/or improvements

Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation

Coordinating with other departments or outside contractors/vendors to complete validation tasks

Assures compliance of local QMS procedure and updates as required

Authors new or revised site procedures as assigned

Participate on project teams as assigned

Qualification

Relevant degree (e.g., biomedical, mechanical engineering or related science / technical discipline)

At least 4 years’ related experience in a medical device company

CQE – an advantage

Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR, etc.)

Experience with statistical techniques, risk analysis, Process validation etc. an advantage

Excellent English language skills (verbal and writing)

Experience with Class III implantable medical devices – an advantage

Experience with working in controlled environment (clean room) – an advantage