About the Role
We are seeking a skilled Quality Assurance Specialist to join our team. This individual will be responsible for ensuring that our products meet the highest standards of quality and safety.
Key Responsibilities:
* Support quality process definition, set up, verification and improvements.
* Complete in-process testing on Product.
* Conduct weekly leak & burst testing on product to ensure product is sealed correctly as per the required specification.
* Verification of the Critical process parameters (CPP`s) & Line Clearance activities.
* Conducting internal process audits to ensure conformance and effectiveness of the Quality System.
* Supporting Audits by demonstrating product testing requirements & best practices.
* Feedback and improvement on Customer 'Supplier Quality Issues'. Prepare for and attend daily engagement process meetings.
* Identify improvements through Quality review and meetings on Quality, Yield, flow, documentation, control etc.
* Escalation of Quality Issues where necessary & conduct non-conformance investigations when required.
* Perform weekly environmental monitoring sampling of the ISO Class 8 Cleanrooms.
* Prepare and review sterile release packs (Endotoxin & Bioburden test reports).
* Conducting & verifying releasing of sterile product.
* Supporting SMT line first off verifications along with verifying line clearance activities.
* Reviewing & approving unplanned maintenance activities when required across multiple assembly lines.
* Determine Lot suitability for release by reviewing production logs and final batch records against product specifications, procedures and electronic data systems.
* Review and approval of Design History Records (DHR) by obtaining and verifying the contents of DHR's against the relevant documentation requirements.
* Interacting with manufacturing execution system (MES) & Oracle Agile systems daily to ensure products are assembled as per the required specification.
* Work space compliance to Site requirements, ESD, MSD, Housekeeping (5S), Safety etc.
* Assure ongoing compliance with quality and industry regulatory requirements.
* Ensure compliance with Health & Safety Legislation and Regulations.
Requirements:
* Minimum NFQ Level 6 Certificate / Diploma in Science or Engineering, or sufficient job-related experience.
* Sound understanding and utilization of problem-solving techniques.
* Proficient in the use of MS Word, Excel and PowerPoint.
* Good communication and influencing skills.
* Ability to write standard operating procedures and training documents.