QA/RA Manager
1 month ago
Position Summary
The Quality Manager will have overall responsibility for the Quality function, including management of the current Quality Management System.
- The Quality Manager is responsible for:
- Ensuring that the processes needed for the Quality Management Systems are clearly documented, effectively communicated, and maintained in accordance with the governing Quality Standards and applicable Regulatory requirements and understood by all employees.
- The Quality Manager is also designated as the Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of MDR 2017/745 and assumes responsibility for ensuring the following:
- Design Release: Device Design conformity is appropriately checked in compliance with the Quality Management System and governing regulatory standards under which the devices are manufactured before a device is released.
- The Technical Documentation is accurate and current at all times.
- The EU Declaration of Conformity is complete and current when applicable.
- Reporting to Top Management on the effectiveness of the quality management system and opportunities for improvement
- Management of the Quality System to ensure its ongoing compliance to the governing Quality and Regulatory Standards and its effectiveness in designing and developing sterile medical devices.
- Management of the Quality System audit program both internally and external audits of critical subcontractors and crucial suppliers.
- Management of the Supplier Agreement program with critical subcontractors and crucial suppliers
- Execute and/or support the Sterilization validation (including clinical cycles) of the FASTWIRE System in compliance with current revisions of SIO 11135 and ISO 10991-7 is desirable.
- Management of all Biocompatibility activities in conjunction with an approved Supplier to ensure compliance with current revisions of ISO 10993 series and FDA guidelines.
- Review and disposition of sterile clinical lots and intended commercial lots in compliance with the QMS
- Manage/support all regulatory Inspections acting in the capacity of primary contact representative.
- Represent company professionally and positively externally to Agencies, Regulators and Suppliers.
- Management of the Quality team to ensure the timely completion of all deliverables.
Knowledge and skills required
- Minimum education of degree in engineering or another relevant scientific discipline.
- Minimum 6 years' experience in the medical device industry, with at least four years of professional experience in Quality Management role within Medical Devices.
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
- Sterilization and Microbiology experience in a medical device company desirable.
- External agency inspection experience
- Accuracy of information essential
- Ability to work well under deadlines and pressure
- Good business acumen.
At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.
Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see wallacemyers.ie/privacy-policy
This position was p P osted on 05 Apr 2024
#J-18808-Ljbffr-
Design Assurance Senior Manager
1 month ago
Galway, Ireland QA Resources Full time[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_mp4=""...
-
Quality Specialist
1 month ago
Galway, Ireland QA Resources Full time[fusion_builder_container type="flex" hundred_percent="no" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_mp4=""...
-
Foreman- Galway
1 month ago
Galway, Ireland John Sisk and Son Full timeFounded in 1859, we are an International Construction Company that strongly emphasises performance, quality, teamwork and a "hands-on” management approach to ensure client satisfaction. Family ownership for five generations has set the cultural tone for John Sisk & Son. We have been Building Excellence for over 150 years by building trust, certainty, and...
-
Senior Design Assurance Manager
4 weeks ago
Galway, Galway, Ireland Cpl Full timeMy client, a global leader in the life science sector, seeks to hire a Senior Design Assurance Manager on a permanent basis. Responsibilities· Develop & manage execution of the Design Controls process.· Provide Design Assurance oversight within the NPI area.· Manage resources to support product launches.· Coordinate regular design reviews.· Ensure...
-
Principal Software Quality Engineer
1 month ago
Galway, Ireland Cpl Healthcare Full timePrincipal Software Quality Engineer My client has an opportunity for a Principal Software Quality Engineer to join them in the design and development of innovative technology. This is an initial 12 month daily rate contract. Duties and Responsibilities: As part of a scrum team, you will: · Actively participate in the development process through...
-
Quality Assurance Technician
2 weeks ago
Galway, Ireland Collins McNicholas Full timeA new and exciting opportunity for a Quality Assurance Technician to join a growing team here in Galway. The Role: As the Quality Assurance Technician you will be responsible for performing duties that help to organise and maintain an effective quality system. Responsibilities: Responsible for monitoring and confirming manufacturing process activities Review...
-
Principal Software Quality Engineer
3 days ago
Galway, Galway, Ireland Cpl Full timePrincipal Software Quality EngineerMy client is looking for a Principal Software Quality Engineer to join their team in crafting and enhancing innovative technology. This role involves working on a 12-month contract basis.Responsibilities:Collaborate within a scrum team to design, write, and maintain various automated testsUtilize your expertise in software...
-
Quality Engineer
1 week ago
Galway, Galway, Ireland Cpl Full timeQuality Engineer My client, a global pharmaceutical and medical device company, who specialises in developing and manufacturing of human pharmaceutical products, seeks to hire a new Quality Engineer. Supporting the Post Market QA team, supports the Business Units fulfil their statutory duties to carry out Post Market Surveillance activities. This role will...
-
Quality Engineer
2 weeks ago
Galway, Galway, Ireland Cpl Full timeQuality Engineer My client, a global pharmaceutical and medical device company, who specialises in developing and manufacturing of human pharmaceutical products, seeks to hire a new Quality Engineer. Supporting the Post Market QA team, supports the Business Units fulfil their statutory duties to carry out Post Market Surveillance activities. This role will...
-
Principal Software Quality Engineer
1 month ago
County Galway, Ireland Cpl Remote Work Freelance Full timePrincipal Software Quality EngineerMy client has an opportunity for a Principal Software Quality Engineer to join them in the design and development of innovative technology. This is an initial 12 month daily rate contract.Duties and Responsibilities:As part of a scrum team, you will:·      Actively participate in the development process...
-
Night Loader
1 month ago
Galway, Ireland Sysco Ireland Full timeSummary:The primary role of the Night Loader is to assist with the Loading, unloading, preparing of Delivery Vehicles for our Drivers. This will involve manual work of loading the delivery vehicles with our products.Key Accountabilities: Assisting with the Loading and unloading of delivery vehicles with stock Preparing of delivery vehicles with Delivery...
-
Senior Software Engineer in Test
1 month ago
Galway, Ireland Fidelity Investments, Ireland Full timeJob Description: Senior Software Engineer in Test At Fidelity Ireland we pride ourselves on a culture that allows you to share, collaborate and be yourself in a dynamic workplace. Our team uses a variety of technologies that either use your current skills or build a platform for continuing to grow by learning new technologies. We have an exciting...
-
Planning Administrator
1 month ago
Galway, Ireland Chanelle Group Full timePlanning Administrator (12 month contract) Loughrea, Co. Galway This is an opportunity to be part of a dynamic team within the Planning function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent...
-
Senior Quality Engineer
2 weeks ago
Galway, Ireland Boston Scientific Full timeOur Mission:At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the...
-
Senior Quality Engineer
2 weeks ago
Galway, Ireland Boston Scientific Full timeOur Mission: At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to...
-
Quality Engineer
1 week ago
County Galway, Ireland Cpl Full timeQuality Engineer   My client, a global pharmaceutical and medical device company, who specialises in developing and manufacturing of human pharmaceutical products, seeks to hire a new Quality Engineer. Supporting the Post Market QA team, supports the Business Units fulfil their statutory duties to carry out Post Market Surveillance...
-
Quality Engineer
2 weeks ago
County Galway, Ireland Cpl Full timeQuality Engineer   My client, a global pharmaceutical and medical device company, who specialises in developing and manufacturing of human pharmaceutical products, seeks to hire a new Quality Engineer.  Supporting the Post Market QA team, supports the Business Units fulfil their statutory duties to carry out Post Market Surveillance...
-
Senior DevOps Engineer
2 weeks ago
Galway, Ireland Fidelity Investments, Ireland Full timeJob Description: Senior DevOps Engineer Strategic Advisor Technology is looking for a Senior DevOps Engineer as a member of our product delivery team. While working to deliver business capabilities across a globally distributed team, we continually strive to advance technology innovation and agile practices and delivery efficiency across the delivery...
-
Quality Engineer
3 weeks ago
Galway, Ireland Celestica Full time08 - Specialist, Operations Quality Req ID: Remote Position: No Hiring Manager: Bobby Smith Band: 08 Region: Europe Country: Ireland State/Province: Galway City: Galway General Overview Position Details: Functional Area: Quality Career Framework Title: Operations Engineering Specialist Internal Job Title: Quality Engineer Job Level: Band 8...
-
Validation Engineer
3 weeks ago
Galway, Ireland Celestica Full time08 - Specialist, Operations Quality Req ID: Remote Position: No Hiring Manager: Bobby Smith Band: 08 Region: Europe Country: Ireland State/Province: Galway City: Galway General Overview Functional Area: Quality (QUA) Career Stream: Operations Quality (OPQ) Role: Specialist (SPE) Job Title: Specialist, Operations Quality Job Code...