- Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
- 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.
- Provide functional expertise to other support functions on quality related issues.
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Review, assessment and approval of change notices for product, process and quality system changes.
- Customer complaints: analysis of complaint trends.
- Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- 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 and support introduction of new products.
- Minimum of Bachelor of Science Degree in Engineering/Technology
- 2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
- Experience in the medical device industry is an advantage.
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email firstname.lastname@example.org