Validation Quality Engineer (6-12 month contract)

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

Job summary

Sanmina Fermoy in Ireland is seeking a Validation Quality Engineer to formulate and execute validation plans for medical devices in a GMP/ISO13485 environment. You will own validation activities, including process and software validation, for Fermoy operations.

The role requires QQI Level 7 degree and at least 2 years QA/regulatory experience, proficiency with DOE, DMAIC, and GAMP methods, and strong MS Office skills.

Qualifications

• Typical requirements include a QQI Level 7 Degree in Science, Electronics, Mechanical or Industrial Engineering.
• Experience in QA/regulatory affairs for medical devices (2+ years).
• Experience conducting process validation per regulatory guidance (CDRH).
• Proficiency with GAMP methodologies and statistical analysis (DOE/DMAIC).
• Proficient with MS Word, PowerPoint and Excel; ability to write SOPs and regulatory responses.

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 and ensure consistency across systems.

Skills

Process Validation

GAMP 4/5

MS Office

DOE & DMAIC

Regulatory compliance

Education

QQI Level 7 Degree in Science/Engineering

Tools

GAMP 4/5

MS Word/PowerPoint/Excel

Job description

Description

JOB TITLE: Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 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 plans 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.