Quality Assurance Lead

The opportunity:

In this role, you will support manufacturing and operation with establishment and overall responsibility of Change Control processes.

In this position you will be asked to:

Manage the overall activities of Change Control in the company, including:

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.

Generate, implement and/or review completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

Review and provide quality oversight of results of validation activities.

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

Investigate and troubleshoot problems and providing recommendations for changes and/or improvements.

Review, edit and approve deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation.

Coordinate 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.

A successful candidate will have the following qualifications:

2-4 years’ related experience in a medical device company

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

Experience with statistical techniques, risk analysis

Excellent English language skills (verbal and writing)

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

Bonus Points:

CQE and process validation knowledge

Experience with Class III implantable medical devices

Experience with working in controlled environment (clean room)