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Senior Quality Engineer

Company: Catalyst Careers
Location: manchester
Posted on: May 3, 2021

Job Description:

Position Summary

Opportunity for Quality individual to join a highly reputable local Medical Devices manufacturer on ensuring their quality systems are compliant and enable their products to be fully effective.

As aleader in their field, they are looking for a highly motivated and high performing individual to drive and streamline quality performances, determine and shape quality processes, and collaborate with this versatile team to achieve personal career goals.

Principal Duties and Essential Functions:

Maintain Quality Database and all ISO documents under ISO:9001 and 21 CFR 820 Lead quality process improvement projects and participate in management reviews Assist in customer, ISO, and FDA audits Customer Quality Assurance Plans Assist in development and implement Quality Plans Work with operations to achieve quality realization using continuous improvement tools Recommend training topics to the QM Assist in quality training to ensure that employees meet the standards. Work with QM to ensure that action items are effectively completed and audited

Qualifications/Skills that are REQUIRED

Bachelors degree or equivalent experience required 1 - 3years in Quality Management Systemswith previous Medical Device manufacturing 21 CFR 829 experience. Strong interpersonal skills and the ability to interact with internal and external customers are essential Experience with medical product manufacturing (GMP, BPR, FMEA, Risk Assessment) Working knowledge of ISO 9001, ISO13485 and FDA regulations Experience with FDA inspections

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

Keywords: Catalyst Careers, Manchester , Senior Quality Engineer, Other , manchester, New Hampshire

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