Cache of job #14033842

Job Title

Product Quality Engineer

Employer

ICDS Recruitment

Location

Dublin North

Description

Product Quality Engineer. This role is being offered as a 24 months' fixed-term contract. Key Purpose: The ideal candidate will be working in an ISO 13485 and FDA 21 CFR Part 820 manufacturing environment, with experience in product and process quality and new product introduction. The successful applicant shall report directly to the QA manager and will be a member of the site QA team collectively responsible for maintaining and improving quality & compliance in the manufacture and support of products and services. Key Responsibilities: Product & Process Quality - Work collaboratively with cross-functional stakeholders (engineering, production and procurement) ensuring value streams comply with QMS requirements and production targets. Experienced in QMS covering a broad range of activities including process change, risk assessment, CAPA, complaint handling, non-conformances, product labelling. You should have demonstrated strong competencies and leadership in these areas. As a member of the site Quality team you will focus on and be responsible for process design improvements and updating quality system procedures in order to achieve both fully compliant and lean processes. Using lean tools, you will own and lead quality projects that deliver quality, cost and process improvements. You should be experienced in working in a production environment to support root cause activity, develop compliant solutions and support ongoing continuous improvement. Support the management of the temporary manufacturing deviation process (TMD) by tracking the status of open and closed deviations. Responsible for reviewing validation plans and reports ensuring these meet regulatory and technical standards, guaranteeing new equipment/process is fit for purpose and commissioning records are correctly documented. Qualifications &Experience. Minimum of a Bachelor’s degree in a relevant technical discipline (ideally Quality, Engineering or Science. At least 3 years' relevant experience in a regulated environment with a core appreciation of FDA regulations. Strong leadership skills and ability to influence cross-functional teams to drive work scope to completion. Cross-technology and cross-discipline collaboration skills. Aptitude for systems level thinking, including development of standard operating procedures. Understanding of statistical analysis and design of experiment experience would be an advantage. This job originally appeared on RecruitIreland.com.

Date Added

1750 days ago

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