Senior Manufacturing Quality Engineer - 12 month FTC

Collins McNicholas Recruitment & HR Services Group; Athlone; On-site; EUR 70,000 - 90,000; Full time

Job summary

Collins McNicholas Recruitment & HR Services Group is recruiting a Senior Manufacturing Quality Engineer on a 12-month FTC for a well-known medical device client in Athlone. The role provides Quality support to processes, materials and products, ensuring CGMP compliance and alignment with ISO/FDA regulatory requirements.

This on-site position requires collaboration with Manufacturing Engineering, risk assessments, FMEA, CAPA investigations and audits to maintain quality metrics and drive

Qualifications

• 4 years experience working in regulated environments, specifically medical device, FDA or ISO 13485-registered work environments preferred.
• Flexible and available to support business needs as required
• Minimum 3 days work on-site – rotating with other engineers
• Engineering or Science Degree
• Experience in a quality engineer or quality specialist role
• Strong computer skills (MS Excel, PowerPoint, Word etc.)
• Familiarity with statistical tools such as Pareto charts and trend charts.
• Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
• Experience with problem solving techniques
• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.

Responsibilities

• Represent Quality function in Site Management meetings as required
• Will act as a delegate for site Manufacturing Quality Lead
• Liaise with Manufacturing Engineering on risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for both new and existing products.
• Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
• Provide guidance on change controls for validation impact.
• Use knowledge of statistics to assist with validation developments and process improvements
• Work with Manufacturing Engineering to develop strategy and sampling plans, for completion of validation for new and existing product lines.
• Lead the analysis and resolution of problems that may reduce the efficient running of production lines.
• Lead and guide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
• Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
• Perform and lead Internal Audits.
• Facilitate and lead external regulatory body audits, i.e., ISO and FDA
• Support the development, analysis and improvement of site Quality Metrics.
• Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
• Will comply with all relevant training required and adhere to relevant associated documentation.
• Follow strict adherence to the requirements of CGMP.
• Lead the enhancement of compliance initiatives for areas of responsibility.

Skills

Quality engineering

Regulatory compliance

Statistical analysis

FMEA & RCA

Auditing

CGMP knowledge

Education

Engineering or Science Degree

Tools

MS Excel

PowerPoint

Word

Job description

Senior Manufacturing Quality Engineer - 12 month FTC

Department: Quality

Contract: Temporary FTC

We are currently recruiting for a Senior Manufacturing Quality Engineer on a 12-month FTC for a our well known medical device manufacturing client based in Athlone. This person will be responsible for Providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and actively supporting the implementation of and compliance to the Quality Management program and for supporting company goals, objectives, policies, procedures, quality systems and compliance with regulatory requirements.

Responsibilities:

• Represent Quality function in Site Management meetings as required


• Will act as a delegate for site Manufacturing Quality Lead


• Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for both new and existing products.


• Review and/or develop and execute facility, software, process and equipment validations and risk management documents.


• Provide guidance on change controls for validation impact.


• Use knowledge of statistics to assist with validation developments and process improvements


• Work with Manufacturing Engineering to develop strategy and sampling plans, for completion of validation for new and existing product lines.


• Lead the analysis and resolution of problems that may reduce the efficient running of production lines.


• Lead and guide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.


• Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.


• Perform and lead Internal Audits.


• Facilitate and lead external regulatory body audits, i.e., ISO and FDA


• Support the development, analysis and improvement of site Quality Metrics.


• Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.


• Will comply with all relevant training required and adhere to relevant associated documentation.


• Follow strict adherence to the requirements of CGMP.


• Lead the enhancement of compliance initiatives for areas of responsibility.

Requirements:

• 4 years experience working in regulated environments, specifically medical device, FDA or ISO 13485-registered work environments preferred.


• Flexible and available to support business needs as required


• Minimum 3 days work on-site – rotating with other engineers


• Engineering or Science Degree


• Experience in a quality engineer or quality specialist role


• Strong computer skills (MS Excel, PowerPoint, Word etc.)


• Familiarity with statistical tools such as Pareto charts and trend charts.


• Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.


• Experience with problem solving techniques


• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.