Quality Systems Specialist

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Quality Systems Specialist


  Hartford,, Connecticut   $80,000 - $100,000

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  Quality    Permanent

Opportunity to join a local Connecticut Medical Devices manufacturer that are expanding their quality team due to an increase in their product portfolio! As part of the larger quality team, you'll have the chance to use your quality systems expertise to advise on new quality system process improvements and define procedures for the site!

Responsibilities 
•    Lead Quality Management System initiatives and continuous improvement activities.
•    Generate project Quality Plans for the QMS and Organizational Objectives.
•    Facilitate organizational compliance training and continual audit/assessment preparedness.
•    Actively support site customer-requested auditing activities (Customer and Regulatory Agencies).

Experience Required:

•    Quality certification(s) (e.g. ASQ CQE, QCI, etc.).
•    Class I, II and/or III Medical Device manufacturing experience.
•    Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
•    Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Callum.Sparkes

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