/Mechanical QA Lead

Mechanical QA Lead

Germanydevia direct
// Job Type
Full Time
// Salary
Not disclosed
// Posted
1 week ago

About the Role

Fohntech Group | Full time Limerick, Ireland | Posted on 02/18/2026 Share this job with your network - Date Opened 02/18/2026 - Job Type Full time - Industry Construction - City Limerick - State/Province Limerick - Country Ireland - Zip/Postal Code V94 We are seeking an experienced Mechanical QA Lead with a robust background in Mechanical Engineering, and a proven track record in both the Pharmaceutical and Construction sectors. This is a unique cross-industry role requiring a deep understanding of GMP, GEP, and engineering best practices to oversee and enhance quality processes throughout the project lifecycle. Key Responsibilities - Lead QA activities across pharma and construction projects, ensuring compliance with GMP, GEP, ISO standards, and other applicable regulations. - Develop, implement, and maintain Quality Management Systems (QMS) to ensure adherence to project, client, and regulatory requirements. - Oversee mechanical system installations (e.g., HVAC, piping, pressure vessels) with a focus on quality and compliance in both cleanroom and construction environments. - Coordinate with multidisciplinary teams including engineering, validation, commissioning, construction, and operations to align quality standards. - Perform supplier and contractor audits, review quality documentation, and ensure proper IQ/OQ/PQ protocols are followed (in pharma). - Lead Non-Conformance (NC) investigations, CAPAs, and root cause analysis for deviations in construction or pharma environments. - Ensure all materials, equipment, and systems used in construction or manufacturing are installed and qualified to meet regulatory expectations. - Participate in project planning, risk assessments, and quality reviews from design through handover phases. - Serve as the primary quality interface with regulatory bodies and client auditors. Required Qualifications & Experience - Bachelor’s degree (or higher) in Mechanical Engineering. - 7+ years of QA experience, with at least 3-5 years in Pharma (GMP environment) and 3+ years in Construction/Infrastructure. - Solid understanding of mechanical systems within GMP manufacturing and industrial construction. - Hands-on experience with validation, commissioning, and qualification processes. - Strong familiarity with regulatory standards such as FDA, EMA, MHRA, and ISO 9001. - Experience implementing or working with QMS platforms (e.g., TrackWise, MasterControl). - Proven experience in managing teams and leading cross-functional quality initiatives. - Excellent written and verbal communication, reporting, and stakeholder management skills. Next Steps If you are interested in this role, please apply directly or email your CV to careers@fohntechgroup.com {{criteriaIndex}} {{field}} {{captialize(condition)}} ( ) {{topMessage}} {{topMessage}} previous next {{score}}% {{message}} Step {{curStepInMandatorySecPrompt}}/{{totalNumOfStepsInMandatorySecPrompt}} For privacy and security purposes, please go through the following points and provide consent. Accept Decline {{cxPropBodyMessage}} {{getI18n("zr.careers.autopopulate.success")}} {{getI18n("zr.cw.apply.sign",cxPropCompanyInfo.name)}} {{getI18n('zr.eeo.questionnaire.portal.maintitle')}} {{botName}}

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