Quality Engineer

RPG Recruitment; Munster; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading FDA manufacturing company in Waterford City is seeking a Quality Engineer. This role involves implementing quality plans and ensuring compliance with FDA and GMP standards. Candidates should have a degree in Engineering or Science and 2 to 4 years of experience in Quality Engineering. Key skills include ISO13485, CAPA, and strong leadership abilities. The position offers benefits such as a pension and healthcare.

Benefits

Pension

Healthcare

Qualifications

• 2 to 4 years’ experience in a Quality Engineering role.
• Fully competent in Quality Management Standards.
• Excellent Leadership skills, ability to motivate team members.

Responsibilities

• Assist in development and implementation of quality plans.
• Provide technical support during the NPI process ensuring compliance with FDA standards.
• Support the implementation of Company Policies and GMP.

Skills

ISO13485

CAPA

Quality Assurance (QA)

PFMEA

GMP

Education

Degree in Engineering / Science (Mechanical / Electronics / Chemistry)

Job description

Quality Engineer required by leading FDA manufacturing company based in Waterford City. Reporting to the Quality Lead the overall purpose of this role is

• The Quality Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses.
• Ensures that performance and product quality conform to established company, customer and regulatory requirements.
• Assists in the review, analysis and reporting on quality discrepancies related to assembly and process.
• May investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies.
• Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.

Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):

• Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
• Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA’s & support the generation of DMF’s where appropriate.
• Uses scrap reduction methodologies and process capability analysis to provide a robust defect free process.
• Individual with an experienced background in sterilisation, automation, equipment/software validation.
• Individual with an experienced background in manufacturing within controlled environments.
• Individual shall support the external & internally Quality Management System auditing function (auditor trained).
• Individual shall have exposure & involvement in supporting the CAPA system.
• Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
• Support the implementation of Company Policies and GMP.
• Support all company safety and quality programs and initiatives.
• Ensure ongoing compliance with GMP in all practices, recording of events and processes.
• Ensure compliance with all learnings from all GMP training events.
• Root cause problem solving approach in a team environment.
• Aligning customer specification to company capabilities.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

Job Specifications: The minimum education and experience required to perform this job competently.

• Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
• 2 to 4 years’ experience in a Quality Engineering role.
• Fully competent in Quality Management Standards.
• Skills/Attributes:
  • Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
  • Excellent organisation, communication, computer & presentation skills.
  • Excellent initiative, decision making and be able to work in a core team environment.
  • Solution driven with emphasis on performance and results.

Skills:

• ISO13485
• CAPA
• QA
• PFMEA
• GMP

Benefits:

• pension
• Healthcare