What you need to know
You will work as the Quality Assurance Technician for our client, a highly successful and established medical device company in Co. Galway.
You will be responsible for performing a variety of Quality and support roles in the production/manufacturing department. You will be a key member of the Quality team charged with establishing, implementing and maintaining the Quality System on-site. You will work within the Quality Department reporting to the Quality Assurance Engineer.
This is a permanent role.
Your new job
Key duties & responsibilities:
- Ensure all processes & equipment are setup per procedure and ready for production.
- Monitor production yields and support yield improvement activities.
- Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining the highest levels of regulatory conformance.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, Bills of Materials, Product routings, Manufacturing procedures, and Logs and ensure that these documents are adhered to at all times.
- Provide Quality support to process validation activities.
- Work as a member of the core team (Supervisor, Training, and Quality) to manage daily line performance, practice versus procedure adherence.
- Liaise with engineers and suppliers to ensure all latest versions of documents are released and available at point of use locations.
- Gather and compile the quality operational monthly Key Performance Indicators reports across the Quality Management system.
- Carry out investigations and generate reports as required to correct non-conformances and implement effective corrective actions.
- Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
- Partner with R&D and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale-up are smooth, timely and cost-effective.
- Conducts root cause analysis and implements corrective action promptly.
- Creates and maintains company quality documentation.
What are we looking for?
- Quality qualification.
- At least 2 years’ experience in a Medical device environment or similar industry.
- An analytical approach to problem-solving.
- A self-starter that applies their initiative in most situations.
- Team player, ability to work on cross-functional teams.
- Strong communication skills.
- Capacity to make sound judgments while learning from mistakes.
- Excellent attention to detail.
- Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
- Displays the highest levels of integrity.
- Capacity to maintain the highest levels of confidentiality internally and externally.
- Ability to stay connected to multiple projects simultaneously.
Apply for this job now or get in touch with Áine on 090 64 90485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgment email and a request for consent where not already expressly given.
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