Four Pharmaceuticals is currently seeking a Quality Engineer to support the Quality Assurance organization with compliance and ongoing conformance to established quality assurance processes and procedures for developing inhalation products and medical devices projects. The Quality Engineer will ensure that all medical device projects will be delivered with the right quality and documentation and be responsible to ensure that the right working procedures and best practice are implemented in the projects. The Quality Engineer will also participate in validation projects.

Description of Duties:
*Provide expert knowledge when it comes to GXP work within the device development.
*Be responsible for the working procedures within device development.
*Ensure that best practice, templates, working procedures, regulations and other standards are implemented within the device projects.
*Facilitate risk events and ensure that risks are mitigated in an effective and secured way within device projects.
*Follow and review new regulations and other standards within the device area.
*Reviews and approves associated protocols and reports.
*Applies risk-based analysis to assess and prioritize the requirements for validation.
*Reviews test requirements and scripts, identifies, resolves and approves test discrepancies to ensure accurate records and summaries of test results.
*Applies quality standards, policies, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution and completion.
*Reviews change controls for new and upgraded processes, computer systems, equipment, and facilities to meet internal company and external government requirements.
*Represent QA in device/validation meetings, discussions and decisions.
*Notify management of quality/compliance trends or failures.
Support GXP compliance and inspection readiness within organization.
Assist during Internal/External Inspections.


Minimum Requirements
*A BS in Life Sciences, or equivalent.
*Minimum of ten years of experience working in the pharmaceutical and/or biotechnology field with a focus on *GMP studies; experience with Inhalation products/devices is a plus.
*At least five years of experience in Quality Assurance preferred.
*Exceptional interpersonal, problem-solving, and written/verbal communication skills.
Ability to work Independently and as a Team Player.

Four Pharmaceuticals offers employees a comprehensive benefits package that includes competitive salaries, comprehensive medical, dental and vision benefits, paid time off and volunteer hours, education assistance and much more.