Description
I have an immediate opening for a Quality Engineer (Compliance) in Cork. This is a 12 month maternity cover contract with one of the leading medical device companies in Cork. (Salary €45K - €55K)Responsibilities:
* Primary Commitment to patient safety and product Quality, and the delivery of key Quality and Performance Objectives.
* Drive and implement process improvements in all areas related to compliance/quality systems
* Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
* 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.
* In depth input into the CAPA system including leading problem solving, root cause analysis and CAPA implementation efforts across a variety of functional areas.
* Define process, product and test method validation requirements, preparation and approval/maintenance of Master Validation Plans, protocols and reports approval.
* Compilation of required Regulatory documentation in relation to external audit responses.
* Trend Review and Analysis in relation to internal audit and CAPA functions and input into cross site trend analysis from a quality systems perspective.
* Perform internal audits
.
Requirements:
- A Bachelors Degree in Science/Engineering/Technology.
- 3/4 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience/training in problem solving and process improvement methodologies.
- Prior experience with CAPA systems in a regulated environment
- Experience in Class 8 cleanroom environments an advantage
- Lead Auditor Qualifications 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 keys to help achieve outcomes.
- Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks in a fast-paced, aggressively results-oriented environment.
This is an excellent opportunity to join a fantastic company on a 12 month contract. If you are interested in this opportunity please apply directly to this advert or contact Derek Sheridan on for further information