Quality Assurance Specialist
We are seeking a Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our products meet the highest standards of quality and safety.
Main Responsibilities:
* Represent quality interests and concerns on project teams.
* Lead risk management activities and own the Quality engineering activities for NPD projects.
* Review design control compliance requirements for NPD projects and all design elements.
* Develop UFMEA & DFMEA, coordinating guidance from other design sub-team members and supporting PFMEA development.
* Perform DOE's and other statistical analysis to support product and process optimization or resolve causes of process variation.
* Initiate corrective actions as required.
* Support assessment of Biocompatibility testing required as per ISO10993 and company procedures.
* Participate in internal audit and supplier audit programmes.
About You:
* Third-level Engineer / Technical / Science Qualification
* Minimum of 5 years in the medical device or pharmaceutical industry desirable
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR
* Attention to detail and adaptability
* Dedication to excellence, flexibility
* Problem-solving techniques with excellent organization skills
* Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to target and deadlines
Benefits:
* Equal Opportunity/Affirmative Action Employer
* No unlawful discrimination based on protected status