What you need to know
You will work as the Quality Systems Technician for our client, a highly successful and established medical device company in Co. Galway.
You will be a key member of the Quality team tasked with establishing, implementing and maintaining the Quality System on-site. You will work within the Quality Department reporting to the Quality Systems Engineer.
This is a permanent role.
Your new job
Key duties & responsibilities:
- Support the Quality Systems Engineer in the maintenance and user training on the EQMS software.
- Support the day to day running of the Quality Management System.
- Gather and compile Quality KPI’s for Site Monthly Management and Corporate Management review meetings.
- Coordinates the complaints handling process. Ensures that the files are audit ready and regulatory reporting requirements are met.
- Coordinates the on-time closure of NCR’s, Planned Deviations and CAPA’s, supports maintaining audit-ready processes.
- Issue, Evaluate & Disposition NCR’s throughout the facility.
- Support Engineers in CAPA investigations. Liaise with various functions to identify the root cause of failures.
- Support the maintenance of the Supplier Management System ensuring Supplier Evaluation & Qualification and on-going monitoring requirements are met and maintained.
- Creates and issues SCAR’s and ensures issues are resolved and effective corrective actions are carried out.
- Continually seeks to drive improvements in product and process quality Participate in six sigma / lean improvement projects.
- Carry out area GMP/GDP audits and follow up on findings to ensure satisfactory closure.
What are we looking for?
- An Engineering or Quality Assurance Degree or equivalent experience.
- Possess an understanding of Quality Systems, is familiar with the Quality System Key processes.
- An analytical approach to problem-solving.
- Good computer skills.
- A self-starter that applies their own initiative in most situations.
- A good team player, who works well in a small dynamic team environment, must be able to work effectively with peers in other Departments.
- A good communicator who can easily convey his/her ideas and requirements across all levels in the organization.
- Capacity to make sound judgments while learning from mistakes.
- Knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese, and other International Regulatory requirements.
- Attention to detail while maintaining awareness of longer-term objectives.
- 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.
- Experience working with EQMS is a distinct advantage.
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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