- Reference: CJ46301
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
The Senior Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.
- Developing and maintaining quality world class systems related to the manufacture of guide wires while developing employee efficiencies,
- Direction for quality in two product manufacturing areas
- The co-ordination and control of one of the key components of the LRI quality system.
- Direction of the relevant inspectors in area of responsibility
- Direction of the relevant quality engineers in area of responsibility
- Playing a role in the plant annual objectives.
- Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485
- FDA QSR
- ISO 14000
- Ensuring continued compliance with DMR
- Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
- Trend analysis of data from the controls
- Potential improvements for review with engineering based on the trends.
- Areas for Improvement to senior management.
- Review and propose changes to sampling plans based on trend analysis and
changes to the system.
- Support the RCA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
- Review and ensure that area of responsibility (and those of direct reports) documents listed below are approved in an appropriate and timely manner
- Engineering Change Order (ECO).
- Request for Corrective Action (RCA).
- Request for Technical assistance (RTA)
- Material Review Request (MRR).
- Internal Audits.
- Failure Mode Effect Analysis (FMEA).
- Variation Permits (VP).
- Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
- Participation in validation protocol development
- Overseeing completion of validation or validation samples
- Supporting the manufacturing engineering function to ensure compliance to related element of quality system.
- Assuring product quality
- Qualification and validation
- Quality direction for RCAs, RTAs, technical issues related to regulatory queries
- Project meeting attendance as required.
- Attend and participate in daily cell meetings.
- Preparation of information for PMR and Management Review meetings.
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of engineering theories and methods.
- Good technical report writing skills.
- Rigorous attention to detail.
Education and Experience Requirements:
- Engineering or science Degree preferably with Quality Engineering included.
- Minimum 5 years’ experience within a regulated environment
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email email@example.com
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