Senior Quality Engineer

Ref. no.: BOS1806

Tags: Quality Engineer Senior Quality Engineer

Location(s): Cork

Salary range (€): 50000 - 60000

Additional benefits:

Minimum experience required: 3 - 4 Years

Employment type: Permanent Full-time

Minimum qualification: See Description

Contact person: Brian O' Sullivan

Contact e-mail: brian@oakrecruitment.ie

Job description:  At Oak Recruitment we are looking to recruit a Senior Quality Engineer and 3 Quality Engineers to provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.


KEY RESPONSIBILITIES
· Supervision of Quality Technicians and Quality Engineers

· 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 their 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: Approval of analysis reports and analysis of complaint trends.

· Validation: Define process and product 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.

· Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities

For further information forward CV to the Email address provided and/or phone Brian on 021 450 5916/ 087 278 9786 for a confidential discussion.