Senior Quality Assurance Specialist
We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a crucial role in ensuring the highest standards of quality and regulatory compliance across all our operations.
Job Description
Responsibilities:
* Develop and execute validation plans for medical devices.
* Own and support validation activities in a Medical Device regulated environment.
* Responsible for all Process Validation Execution.
* Responsible for all Software Validation Execution.
* Resolution of Problems encountered during validation.
* Ensure Consistency in validation/qualification approach across systems and projects.
* Provide guidance and direction in the preparation and execution of validation activities.
* Maintain Validation system including conducting Periodic Reviews.
* Participate in change control processes for manufacturing process and facility modifications.
Requirements:
* QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
* Minimum of 2 years Quality Assurance / Regulatory affairs experience.
* Experience in completing Process Validation's as per CDRH Guidance.
* Experience in using Gamp 4 or Gamp 5 Software V and V Techniques.
* Sound understanding and utilization of Problem Solving Techniques.
* Proficient in the use of MS Word, Power-point and Excel.
* Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
* Ability to write standard operating procedures, training documents, and regulatory responses.
Benefits:
* Opportunity to work with a leading medical device manufacturer.
* Competitive salary and benefits package.
* Ongoing training and development opportunities.
About Us:
We are a leading medical device manufacturer with a strong commitment to quality and regulatory compliance. We are dedicated to providing innovative solutions that meet the needs of our customers and improve patient outcomes.