QA Specialist Part-time €65-80K - Expired
|Job Title||QA Specialist Part-time €65-80K|
|Salary||Up to €0.00 per annum|
|Location||Galway, Republic of Ireland|
|Job Advertised||7 months ago|
QA Specialist Part-time €65-80K
Great opportunity for a QA professional to join a medical device start-up and help set up and maintain a QMS and manage documentation for the ISO 13485. Working closely with an external Quality Consultant this role gives you the opportunity to hone your QA skills and help the company work towards CE Marking certifications and ISO certifications. You will also be responsible for engaging with the medical device regulator.
The company have big growth plans with current operations in the middle east and plan to enter new markets in Europe, The Middle East and Asia within the coming 12 months.
What's in it for you?
- Salary- €60-80K (pro-rata)
- Duration- 12 months initially (full time perm after 12 months subject to ISO)
- Benefits such as pension, healthcare
- Opportunity to play a key role in a medical device start-up who are destined for major growth
What would your responsibilities look like?
- To create and maintain the necessary documentation for the ISO 13485.
- Set up and maintain the Quality Management System (QMS).
- You will be working closely with an external consultant on the CE Marking of the new products.
- To manage a close working relationship with regulators and the notified bodies and later to be involved in regulatory affairs.
- Engineering/Science degree qualification with 5+ years of working experience within a medical device environment in a similar capacity.
- Good technical writing experience within a medical device environment.
- Knowledge of Quality and Regulatory requirements and regulations including but not limited to ISO 13485 Quality System requirements, Council Directive 93/42/EEC (Medical Device Directive), MEDDEV.
If you are looking for work life balance and a part-time Quality role, then this QA specialist role may be a good fit. To be considered for this role apply now with CV. You can also reach out with your LinkedIn profile to Som in Principle. All CVs/profiles are reviewed in the strictest confidence.
For more info contact Som Rajendra Email: firstname.lastname@example.org Ph: 016035075