Quality Assurance Consultant

Proclinical have teamed up exclusively with a Medical Device company in Massachusetts who specialise in providing functional care for people with Diabetes. They are looking for a Quality Assurance consultant to work in collaboration with the Device Quality Assurance manager who will establish the quality system necessary for pre-clinical studies and Phase I Clinical Device Manufacturing.

Job Responsibilities:

• Quality project planning for device manufacturing.
• Establishing appropriate training programs for employees as to their impact in the quality management system.
• Guiding the development, implementation and integration of the QMS.
• Supporting concurrent engineering efforts by participating in design development projects representing quality assurance.
• Establishment and implementation of metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.

Skills and Requirements:

• Masters degree, or equivalent number of years of experience. Engineering background preferred.
• Minimum 10-years' experience in QA systems implementation.
• Minimum 5-years' working in a regulated environment, including the medical devices industry.
• Experience with Quality Management System (ISO 13485), Medical Device Regulations (21 CFR 820) and applicable regulatory requirements and standards.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Joseph Emmott at +44 203 814 1316 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

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