Are you a Quality Engineer with operations experience within the Medical Device, Biotech or Pharma industries? Would you like to work for a leading Medical Device company, based in Galway. To apply send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Operations Quality Engineer - Galway
Employer
Our Client is one of the leading global medical device outsourcing providers and leader in the provision of technologies and services for minimally invasive delivery and access devices. They have a state of the art design and manufacturing campus in Galway.
Job Description
The Operations Quality Engineer is a member of the Operations Quality group.
S/he is, responsible for Operations Quality within their prescribed area of functional responsibility.
The Operations Quality Engineer is a member of the Operations Quality group.
S/he is, responsible for Operations Quality within their prescribed area of functional responsibility.
S/he will be working as part of a team to maintain high quality / performance standards on all Company Medical products.
This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Company Medical Quality System
Key Job Responsibilities:
Overall responsibility for production GMP standards and compliance.
Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
Establishing inspection standards, plans, frequencies and test methods.
Establishing and maintaining FMEA’s.
Preparing and updating Operations procedures and associated documentation.
Reporting area of responsibility metrics.
Supporting customer and surveillance accreditation audits.
The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
Maintain relevant documentation to comply with quality standards and customer requirements.
Develop strong links with customer organisation’s and other project stakeholders.
Quality review of responsible area validation documentation.
Performing an active role in further development and continuous improvement of the quality management system.
Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc.
Other duties as assigned from time to time.
Requirements:
Degree in Quality or Degree in Science / Engineering.
Experience within a similar role as quality engineer.
5+yrs industry experience in a medical device-manufacturing orpharmaceutical environment.
Working knowledge of FDA and ISO Quality systems for Medical device companies.
New product introduction and manufacturing process transfer experience would be a distinct advantage.
Quality experience in component and device manufacturing desirable.
Excellent written and oral communication skills essential.
Package:
Negotiable for right candidate
Permanent position
Pension & Health Insurance
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Jobs in Galway
Are you a Quality Engineer with operations experience within the Medical Device, Biotech or Pharma industries? Would you like to work for a leading Medical Device company, based in Galway. To apply send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Operations Quality Engineer - Galway
Employer
Our Client is one of the leading global medical device outsourcing providers and leader in the provision of technologies and services for minimally invasive delivery and access devices. They have a state of the art design and manufacturing campus in Galway.
Job Description
The Operations Quality Engineer is a member of the Operations Quality group.
S/he is, responsible for Operations Quality within their prescribed area of functional responsibility.
The Operations Quality Engineer is a member of the Operations Quality group.
S/he is, responsible for Operations Quality within their prescribed area of functional responsibility.
S/he will be working as part of a team to maintain high quality / performance standards on all Company Medical products.
This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Company Medical Quality System
Key Job Responsibilities:
Overall responsibility for production GMP standards and compliance.
Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
Establishing inspection standards, plans, frequencies and test methods.
Establishing and maintaining FMEA’s.
Preparing and updating Operations procedures and associated documentation.
Reporting area of responsibility metrics.
Supporting customer and surveillance accreditation audits.
The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
Maintain relevant documentation to comply with quality standards and customer requirements.
Develop strong links with customer organisation’s and other project stakeholders.
Quality review of responsible area validation documentation.
Performing an active role in further development and continuous improvement of the quality management system.
Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc.
Other duties as assigned from time to time.
Requirements:
Degree in Quality or Degree in Science / Engineering.
Experience within a similar role as quality engineer.
5+yrs industry experience in a medical device-manufacturing orpharmaceutical environment.
Working knowledge of FDA and ISO Quality systems for Medical device companies.
New product introduction and manufacturing process transfer experience would be a distinct advantage.
Quality experience in component and device manufacturing desirable.
Excellent written and oral communication skills essential.
Package:
Negotiable for right candidate
Permanent position
Pension & Health Insurance
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Jobs in Galway
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
