Quality Engineer Job

Requisition ID: 17007BR
Job Title: Quality Engineer
Division: Implants Ops
Business Unit: Cork
Business Functions: Quality Assurance Safety
Focus Area General/Other: Quality Assurance/Safety
Country: Ireland
State: -
City: Cork
Shift: N/A

Job Description:
Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
- Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI).
- Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
- Ensure compliance of QMS procedures within the Business Unit.
- Lead Problem Solving meetings using the following: 4D, Six Sigma, etc.
- Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
- Drive and implement plant wide quality system improvements.
- Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.
- Provide functional expertise to other support function on quality related issues.
- Manage NCR Process.
- Interface with Suppliers for new processes, quality Issues and Process Improvements.
- Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
- Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
- Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, sCAPA, Validations, Process Changes, NCR, Quality Alert, Quality Challenge.
- Complete Manufacturing Cell Audits, Internal Audits Supplier Audits, as required.
- Support site during External Audits. (i.e. FDA, IMB and BSI).
- Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
- Responsible for input to Quality Metrics.
- Evaluation of Customer Complaints (PER Investigation) as required.

Qualifications/Work Experience: Degree in Engineering, Science or equivalent is required.
- Minimum of 2 years experience in a QA role.
Education and/or Special Training: Good level of technical and analytical skills.
- Problem Solving Skills and ability to handle multiple tasks in a fast paced environment.
- Capable of working as part of a multi discipline team.
- The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
- High level of PC skills required.
- Excellent Communicator

Percent Travel Required: 10%

Job Segments: CAPA, Compliance, Customer Service, Engineer, Engineering, Healthcare, Law, Legal, Management, Manufacturing Engineer, Medical Device, Product Development, QA, Quality, Quality Assurance, Quality Engineer, Research, Six Sigma, Technology