Quality Manager and Design Assurance Manager

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A medical device start-up in Galway have been recently acquired by an international medical device company. With Galway being home to their R&D centre, they're going through an exciting phase for vascular technologies product development and to increase headcount this year.

There are two permanent management positions that have just opened up to accommodate their plans for growth:

QUALITY MANAGER

As Quality Manager, you will ensure that all product released by the company for human use meets the product quality requirements. You will also ensure that product is manufactured, released and distributed in accordance with regulatory requirements.

Some of your day-to-day will include:

* Managing the relationship with, and mentoring, the finished device Manufacturing Subcontractor / Supplier to ensure that the company product quality and compliance requirements are achieved.

* Leading the company QA responsibilities in preparing the Manufacturing Subcontractor and Stent Supplier for Regulatory Body Inspections/ Audits, as required.

* Reviewing and contributing to Process Validation & Risk Management activities of the Manufacturing Subcontractor and Stent Supplier.

* Managing SCAR, CAPA and NC activities associated with the Manufacturing Subcontractor, Stent Supplier & post product release.

* Support the Senior Quality System Engineer in the execution of QMS activities linked to the principal responsibilities above.

* Auditing of subcontractors, suppliers and members of the distribution network as required.

Requirements:

Degree in Engineering, Science or Quality Assurance discipline. 7 years' medical device manufacturing quality experience is required, in a medical Device manufacturing environment, at least at Senior Quality Engineer level or highly comparable. Experience of managing relationships with subcontractors and suppliers is essential along with experience in performing process validation and risk management activities is required.

DESIGN ASSURANCE MANAGER

As Design Assurance Manager, you will be working as part of the development teams in the development of new products. You will be working predominantly on projects to introduce or improve products for treatment of vascular diseases. You will be a key player in the company's product development and commercialisation strategy.

Some of your day-to-day will include:

* Working within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device regulations

* Leading the development / evolution of the company Design Control, Risk Management and associated systems, to encompass new product development technologies.

* Define design assurance requirements for projects and design changes, including resourcing and timeline planning.

* Lead the risk management activities for designated projects and design changes.

* Design, development and validation of test methods as required to support development programs.

* Develop and maintain design verification and validation plans, protocols and reports.

* Establish and maintain the Design History File and associated documents.

* Participate in the company's Audit and CAPA programs

Requirements:

Degree in Engineering, Science or Quality Assurance discipline. 7 years' in a comparable roles in the medical device industry, at least at Senior Design Assurance Engineer level or similar. An understanding of ISO13485, ISO14971 and FDA QSRs is a prerequisite. Familiarity with statistics, validation and physical testing is required.

Please apply with your current CV if you are interested in either of these roles and I will contact you to discuss further.

Sponsorship is not offered, EU passport or Stamp 4 Visa is essential.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales