Quality Project Specialist

6 days ago

Newtownards Co Down, United Kingdom Eakin Healthcare Full time €30,000

ABOUT THE ROLE A member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions.
Make your application after reading the following skill and qualification requirements for this position.
As a key role in the Group Operations Compliance Team strategy, provide business support and guidance in line with the Group Operations Compliance and Eakin Healthcare Strategies.
With the role located at one of our three operations sites, this is an excellent opportunity for an individual to work closely with both site-based functions and colleagues and wider group colleagues in the Group Operations Compliance Team.
KEY ACTIVITIES Involved in the creation, improvement and maintenance of regulatory compliant Quality Management System (QMS) documentation (and training thereof) that will include, but not be limited to: QMS reports and analysis of reports for review by the Quality Manager.
Quality reports for review at Management Review meetings.
Reviewing and actioning feedback from customers.
Create, review and maintain operating procedures, quality forms and work instructions.
QMS studies and reports e.g.
stability studies Identification, investigation and documentation of product and process non-conformances document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements Risk assessments associated with QMS updates.
Provide first line supervisory support to Quality Officers, in areas of personal development and objective setting.
Execute and lead the timely release of finished medical devices to ensure schedules are maintained and stock available.
Oversee and co-ordinate the accurate completion, retention, and review of product release documentation, liaising where necessary with the relevant internal stakeholders and ensuring all product release documentation complies with the appropriate site regulatory certification and standards (ISO13485, MDSAP, GMP, GDP, FDA CFR).
Inform, collate and analyse quality feedback data ensuring that key information is relayed to the Quality Manager.
Perform internal audits to schedule.
Assisting the Quality Manager with the achievement of annual objectives as required.
Monitor, trend and analyse quality metrics and suggest improvement activities as required.
Assist at third party audits and inspections across Eakin Healthcare as required.
Assist with ensuring the QMS reflects practice and is kept up to date in line with requirements.
Ensure all reported Customer Complaints are acknowledged, investigated, and reported.
In conjunction with other departments, ensure all stability studies are documented, actioned, and reported.
Facilitate meetings to track, support, coordinate and where applicable, complete closure of Corrective and Preventative Actions, Customer Complaints, Non- Conformances and subsequent product dispositions e.g.
product rework administration, Concessions.
Be accountable and ensure compliance of Calibration Support the change control system by accurate completion of documentation and realising any relevant actions.
Other To adhere to the companys Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
To be responsible for your own health and safety and that of your colleagues, in accordance with the companys Health and Safety policy.
To adhere to the companys Quality policy and Environmental policy.
To undertake other duties as may be reasonably required.
KEY SKILLS Essential A level or equivalent and/or, a minimum of five years experience in medical device manufacturing.
Proven experience in a volume manufacturing regulated environment in a Quality based role, with compliance experience to a quality standard.
Strong interpersonal and communication skills.
Able to quickly build effective professional working relationships.
Meticulous with high levels of attention to detail.
Strong command of written English.
Excellent verbal communication skills.
Excellent organisational and planning skills to deliver efficient QMS based outputs.
Proactive and able to work unsupervised.
Ability to work well in a team.
Competent in the use of Microsoft office Desirable Experience of working in a product/batch release role in the medical device/pharmaceutical industry.
Experience of working in a regulated manufacturing environment (e.g., ISO13485, ISO14971, MDD, EU MDR, MDSAP).
Experience of using an electronic quality management system (eQMS).
Experience in good documentation practices (GDP).
Experience in a medical device / life sciences environment.
Experience of using problem solving and root cause analysis tools (8D, FMEA etc.).
Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer complaint/audit issues.
Experience in development of training materials and delivery of training presentations.
Quality auditing certification.
Methodical with analytical and problem-solving KEY WORKING RELATIONSHIPS Internal R & D to ensure that quality and regulatory requirements are met during new product introduction projects Production to liaise with production personnel at all levels to ensure requirements for quality are defined and met.
Develop, implement and maintain appropriate quality metrics.
External Dealing with suppliers to discuss quality related issues and improvements.
Dealing with customers and third-party auditors during quality audits ADDITIONAL INFORMATION Occasional travel to other companies within the group and to supplier premises may be required.
Access to transport Skills: CAPA ISO13485 Complaint Investigations Quality System Non-conformances MDSAP Medical Devices Benefits: Paid Holidays Pension Fund Performance Bonus Parking Group Life Assurance

  • Quality Assurance Specialist

    5 days ago

    Newtownards, Co. Down, United Kingdom Eakin Healthcare Full time £26,000

    About the RoleA key member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.Key ResponsibilitiesInvolved in...

  • Quality Assurance Specialist

    5 days ago

    Newtownards, Co. Down, United Kingdom Eakin Healthcare Full time £26,000

    About the RoleA key member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and regulatory compliance of our medical devices.Key ResponsibilitiesInvolved in...

  • Quality Assurance Specialist

    5 days ago

    Newtownards, Co. Down, United Kingdom Eakin Healthcare Full time £30,000

    About the RoleA key member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a Quality Project Specialist, you will be responsible for providing business support and guidance in line with the Group Operations Compliance and Eakin Healthcare...

  • Quality Assurance Specialist

    5 days ago

    Newtownards, Co. Down, United Kingdom Eakin Healthcare Full time £30,000

    About the RoleA key member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a Quality Project Specialist, you will be responsible for providing business support and guidance in line with the Group Operations Compliance and Eakin Healthcare...

  • Quantity Surveyor

    4 days ago

    Newtownards, Co. Down, United Kingdom Hays Specialist Recruitment Full time £40,000

    Job Title: Quantity SurveyorHays Specialist Recruitment Limited is seeking a skilled Quantity Surveyor to join their Asset Management team in Newtownards on an ongoing temporary contract basis.Job Summary:The successful candidate will be responsible for ensuring the effective commercial management of Planned Works and Compliance related investment to NIHE...

  • Quantity Surveyor

    4 days ago

    Newtownards, Co. Down, United Kingdom Hays Specialist Recruitment Full time £40,000

    Job Title: Quantity SurveyorHays Specialist Recruitment Limited is seeking a skilled Quantity Surveyor to join their Asset Management team in Newtownards on an ongoing temporary contract basis.Job Summary:The successful candidate will be responsible for ensuring the effective commercial management of Planned Works and Compliance related investment to NIHE...

  • Purchasing Specialist

    6 days ago

    Newtownards, Co. Down, United Kingdom Eakin Healthcare Full time €35,000

    ABOUT THE ROLE The Procurement Specialist will report to the Group Head of Procurement, covering allocated Indirect procurement activities. Working with key internal stakeholders and suppliers to deliver continuous improvements to service levels and supporting the evolution of Group Procurement across the Business. Supporting the Group Head of...

  • Quality Assurance Specialist

    5 days ago

    Ballymena, Co. Antrim, United Kingdom Hays Specialist Recruitment Full time £34,242

    Job Title: Quality InspectorJoin Hays Specialist Recruitment as we seek a skilled Quality Inspector to join our client, the Northern Ireland Housing Executive (NIHE), in Ballymena.About the Role:As a Quality Inspector, you will be responsible for conducting inspections and measurements on construction sites to ensure compliance with statutory regulations,...

  • Quality Assurance Specialist

    5 days ago

    Ballymena, Co. Antrim, United Kingdom Hays Specialist Recruitment Full time £34,242

    Job Title: Quality InspectorJoin Hays Specialist Recruitment as we seek a skilled Quality Inspector to join our client, the Northern Ireland Housing Executive (NIHE), in Ballymena.About the Role:As a Quality Inspector, you will be responsible for conducting inspections and measurements on construction sites to ensure compliance with statutory regulations,...

  • Quality Assurance Specialist

    3 days ago

    County Down, United Kingdom REED Specialist Recruitment Full time

    Quality General Operative Job DescriptionWe are seeking a highly motivated and detail-oriented Quality General Operative to join our team at REED Specialist Recruitment. As a Quality General Operative, you will play a crucial role in maintaining our high standards of product safety and quality.Key Responsibilities:Conduct product safety checks, including...

  • Quality Assurance Specialist

    3 days ago

    County Down, United Kingdom REED Specialist Recruitment Full time

    Quality General Operative Job DescriptionWe are seeking a highly motivated and detail-oriented Quality General Operative to join our team at REED Specialist Recruitment. As a Quality General Operative, you will play a crucial role in maintaining our high standards of product safety and quality.Key Responsibilities:Conduct product safety checks, including...

  • Construction Project Coordinator

    5 days ago

    Newry, Co. Down, United Kingdom Hays Specialist Recruitment Full time £35,000

    Job Title: Construction Project AdministratorWe are seeking a highly organized and detail-oriented Construction Project Administrator to join our team. As a key member of our administration team, you will provide critical support to our construction projects, ensuring seamless execution and timely completion.Main Responsibilities:Provide administrative...

  • Construction Project Coordinator

    5 days ago

    Newry, Co. Down, United Kingdom Hays Specialist Recruitment Full time £35,000

    Job Title: Construction Project AdministratorWe are seeking a highly organized and detail-oriented Construction Project Administrator to join our team. As a key member of our administration team, you will provide critical support to our construction projects, ensuring seamless execution and timely completion.Main Responsibilities:Provide administrative...

  • Quality Assurance Specialist

    1 week ago

    Newtownards, United Kingdom Eakin Healthcare Full time

    About the RoleWe are seeking a highly skilled Quality Specialist to join our Operations Compliance team at Eakin Healthcare. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our medical devices.Key ResponsibilitiesDevelop and maintain regulatory compliant Quality Management System (QMS) documentation and...

  • Quality Assurance Specialist

    1 week ago

    Newtownards, United Kingdom Eakin Healthcare Full time

    About the RoleWe are seeking a highly skilled Quality Specialist to join our Operations Compliance team at Eakin Healthcare. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our medical devices.Key ResponsibilitiesDevelop and maintain regulatory compliant Quality Management System (QMS) documentation and...

  • Quality Assurance Specialist

    1 week ago

    Newtownards, United Kingdom Eakin Healthcare Full time

    About the RoleWe are seeking a highly skilled Quality Specialist to join our Operations Compliance team at Eakin Healthcare. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our medical devices.Key ResponsibilitiesDevelop and maintain regulatory compliant Quality Management System (QMS) documentation and...

  • Quality Assurance Specialist

    1 week ago

    Newtownards, United Kingdom Eakin Healthcare Full time

    About the RoleWe are seeking a highly skilled Quality Specialist to join our Operations Compliance team at Eakin Healthcare. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our medical devices.Key ResponsibilitiesDevelop and maintain regulatory compliant Quality Management System (QMS) documentation and...

  • Clinical Specialist

    3 days ago

    Newtownards, Co. Down, United Kingdom Donard Recruitment Full time £40,000

    Unlock Your Potential as a Functional SpecialistAre you a qualified Nurse, Occupational Therapist, Physiotherapist, or Paramedic looking to take your career to the next level? Do you have a passion for delivering high-quality, patient-centered care? If so, we have an exciting opportunity for you to join our team as a Functional Specialist.About the RoleAs a...

  • Clinical Specialist

    3 days ago

    Newtownards, Co. Down, United Kingdom Donard Recruitment Full time £40,000

    Unlock Your Potential as a Functional SpecialistAre you a qualified Nurse, Occupational Therapist, Physiotherapist, or Paramedic looking to take your career to the next level? Do you have a passion for delivering high-quality, patient-centered care? If so, we have an exciting opportunity for you to join our team as a Functional Specialist.About the RoleAs a...

  • Project Manager

    5 days ago

    Newtownards, Co. Down, United Kingdom VanRath Full time £35,000

    Project Manager Job DescriptionWe are seeking a highly skilled Project Manager to join our client, a large Public Sector Organisation, in their search for an experienced professional to manage onsite and coordinate Major Adaptations delivery.Key Responsibilities:Lead on project management of major adaptations construction within agreed timeframes, quality,...