Job Description
An excellent opportunity for a motivated and driven Quality professional who is looking for a company that will allow them ownership and accountability, as well as an opportunity to continuously develop.
The successful candidate will be working with one of the world leaders in life-changing medical solutions at their Cork site. This role would be ideal for individuals with 4+ years' experience in a regulated manufacturing facility (pharma, medical device or electronics) and those who enjoy supporting, leading and developing a team around them.
This is a fast-paced, dynamic environment that requires someone who can work independently and proactively. The company invests heavily in its people and this role offers excellent exposure to business leads.
The main focus of this role is to provide QA support to Operations and to support process implementation from a QA standpoint.
* Supervision of Quality Technicians and Quality Engineers
* Driving and implementing process improvements (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
* Providing effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output
* Ensuring all failure modes in process have been identified and addressed (e.g. Use of DOE studies, FMEA's)
* Driving and implementing plant-wide quality system improvements
* Ensuring Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV)
* Approval of change requests for product, process and quality system changes
* Customer complaints: Approval of analysis reports and analysis of complaint trends
* Validation: Defining 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
* Performing internal quality audits
* Supporting the implementation of Lean Manufacturing across the site
* Transferring and implementing product and processes from development or from another manufacturing facility
* Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities
Requirements:
* A minimum level 8 qualification in a relevant Engineering/Science degree
* Excellent interpersonal and communication skills
* Able to work as part of a team and meet targets/goals efficiently
* Excellent analytical and problem-solving skills
* Demonstrated decision-making skills
* A minimum of 4+ years' experience within a manufacturing environment
* People management experience is advantageous
* Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment