Description
I have exciting openings for 2 Quality Engineers with a fantastic medical device company based in Cork. These are excellent opportunities to work in a great environment where you will learn and develop. This company is voted as one of the best places to work and offers excellent opportunities for career progression.Responsibilities:
. Supervision of Quality Technicians.
. Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
. Provide effective and responsive QA support to Operations to meet the area's objectives of quality, cost and output.
. Ensure all process variables and their interactions are adequately defined.
Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's)
. Drive and implement plant wide quality system improvements.
. Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV)
. Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
. Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)
. Approval of change requests for product, process and quality system changes.
. Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
. Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
. Compilation of required Regulatory documentation (e.g. Technical files, Design
Dossiers, Product transfer files, Essential requirements)
. MRB: Review of MRB trends and identification of appropriate corrective actions when required.
. Perform internal quality audits.
. Support the implementation of Lean Manufacturing across the site.
. Transfer and implement product and processes from development or from another manufacturing facility.
. Build Quality into all aspects of their work by maintaining compliance to all quality requirements
. All other duties as assigned.
QUALIFICATIONS/EXPERIENCE REQUIRED:
. Minimum qualification: BSC/BEng degree.
. Minimum of 2/3 years' experience in a QA role.
. Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
. Strong project management skills.
. Good level of technical and analytical expertise to assist in problem solving
. Experience in process improvement methodologies an advantage. (Engineering Essentials TM)
. Good knowledge of statistics would also be an advantage.
. Experience in Class 8 cleanroom environments an advantage
. Experienced in all types of regulated audits an advantage (FDA, Notified Body, Corporate)
. Builds strong relationships by fostering open communications, respect and trust. Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.
. Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, results-oriented environment.
. Builds strong customer engagement and credibility by delivering on expectations and commitments.
. Is open to change and analyses successes and failures for continuous improvement to quality, time and cost targets.
. Strong team player who effectively utilises individual strengths and talents to maximise team services to customers. Focuses on achievement of team objectives and team success.
If you are interested in hearing more about these great opportunities please apply directly to this advert or contact Derek Sheridan on for immediate consideration