We are looking for a Quality Assurance Medical Devices Specialist for one of our clients in Dublin (Ireland).
Length of the project: initially for 6 months
Reporting to the Responsible Person, Global Supply Chain & OEU commercial quality
Quality Assurance Medical Devices Specialist
To provide QA support for Economic Operator implementation of the medical device regulations for go live MAY2020. Ensure EO sampling is documented and activities are carried out as per MDR guidelines. Carry out activities such as technical/ quality agreement updates, documentation review, Risk Assessment Review, change control Management and project coordination, update training material as required. Carry out project management activities & communications to QA and related teams with regards new processes and delegated activities.
100% of the time - Implementation of the Economic Operator MDR project for GSC
Responsible for the implementation of the APIL EO technical agreements & review of impact to Quality system due to additional delegated activities:
- Support local QMS to ensure change control is aligned to project and other QMS tools
- Ensure alignment between local quality SOP’s, regional quality SOP’s for updates related to EO process updates, review and update as required.
- Support and document Risk Assessment for MDR.
- Maintain project dashboards and project charters, activity tracker and communication plan & execute.
- Design and develop KPI/ metrics for MDR delegated activities.
- Ensure all APIL vendors have TAs updated
- EU LRDs
- APIL 3PLs
- APIL EU distributors
- Company medical device manufacturers
- Company third party medical device manufacturer
- Support design and generation of verification process for EO sampling – certification of compliance/ conformance.
- Other elements of MDR project as required.
Education & Experience
- The equivalent of 3 years college education in a medical/scientific related field. At least 3 years’ experience in quality related or production in the pharmaceutical or medical device industry.
- Previous administrative experience, ideally in a pharmaceutical or medical device company.
- Previous experience with ISO standards knowledge of MDR and implementation (ISO13485)
- Quality systems required for pharmaceutical/ medical device industry.
- Excellent administrative skills, project management; including good proficiency in Word, Excel and PowerPoint.
- Willingness to learn new additional software packages as necessary.
- Ability to manage own workload without supervision.
- Ability to demonstrate flexibility in responding to urgent requests
- Ability to operate according to agreed performance standards such as timelines.
- Observe and comply with company standards and procedures.
- Enthusiasm and quality improvement orientation
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