Validation Quality Engineer (6-12 month contract)

Sanmina; Fermoy; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sanmina Fermoy seeks a Validation Quality Engineer to join the Quality Department. The role focuses on developing and executing validation plans for medical devices in a GMP-regulated setting, including process and software validation across Fermoy operations.

The ideal candidate has a QQI Level 7 degree in a relevant field and at least 2 years in QA/regulatory roles, with strong knowledge of GMP and CDRH guidance. Collaboration with cross-functional teams is essential.

Qualifications

• QQI Level 7 Degree in a relevant science/engineering field.
• Minimum of 2 years Quality Assurance / Regulatory affairs experience.
• Experience performing Process Validation per CDRH Guidance.
• Familiarity with GAMP 4 or GAMP 5 software V&V techniques.
• Strong problem solving and analytical skills.
• Proficient in MS Word, Excel and PowerPoint; able to draft SOPs and regulatory responses.
• Experience with statistical analysis, DOE and DMAIC methods.

Responsibilities

• Own and support validation activities in a Medical Device regulated environment.
• Responsible for all Process Validation Execution in Fermoy.
• Responsible for all Software Validation Execution in Fermoy.
• Resolution of problems encountered during validation.
• Ensure consistency in validation/qualification approaches across systems and projects.
• Provide guidance in preparation and execution of validation activities.
• Remain up-to-date with GMP requirements for site-wide regulatory compliance.
• Maintain the Validation system including periodic reviews.
• Participate in change control processes for manufacturing and facility changes.
• Ensure ongoing regulatory compliance and health & safety regulations.

Skills

Quality Assurance

Regulatory affairs

Process Validation

GAMP 4/5

Problem Solving

Statistics / DOE / DMAIC

MS Word

Excel

PowerPoint

Education

QQI Level 7 Degree in Science / Electronics / Mechanical / Industrial Engineering

Six Sigma Green or Black Belt

Tools

GAMP 4/5 Software V&V Techniques

Job description

About Sanmina Fermoy

Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.

Job Description

JOB TITLE: Validation Quality Engineer

DEPARTMENT: Quality Department

REPORTING TO: Validation Quality Lead

About Sanmina Fermoy

Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.

Sanmina Fermoy’s core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce.

We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few.

Objectives Of Position

• To formulate and execute validation planes for medical devices.

Responsibilities

• Own and support validation activities in a Medical Device regulated environment.
• Responsible for all Process Validation Execution in Fermoy.
• Responsible for all Software Validation Execution in Fermoy.
• Resolution of Problems encountered during validation.
• Ensure Consistency in validation/qualification approach across systems and projects.
• Provide guidance and direction in the preparation and execution of validation activities.
• Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
• Maintain Validation system including conducting Periodic Reviews.
• Participate in change control processes for manufacturing process and facility modifications.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Ensure compliance with Health & Safety Legislation and Regulations.

Measurements

• Timely and accurate completion of Validations.
• Compliance with regulatory Standards and requirements.

PERSONNEL SPECIFICATIONS

Essential

• QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
• Minimum of 2 years Quality Assurance / Regulatory affairs experience.
• Experience in completing Process Validation’s as per CDRH Guidance.
• Experience in using Gamp 4 or Gamp 5 Software V and V Techniques.
• Sound understanding and utilization of Problem Solving Techniques.
• Proficient in the use of MS Word, Power-point and Excel.
• Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
• Ability to write standard operating procedures, training documents, and regulatory responses.
• Technically Competent.
• Experience in statistical Analysis / DOE and DMAIC methods.

DESIRABLE

• Experience in working within a Medical Device Manufacturing Environment.
• Six sigma Green or Black Belt Certified.
• Experience of electronic production processes.