Crest Solutions are seeking a Senior Quality Engineer / Team Lead to join our team, work on our customer site in Cork and provide expert QA support to Operations ensuring operational goals and objectives are achieved.
What We Do:
Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.
Responsibilities and Tasks:
- 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. files, Design Dossiers, Product transfer files, Essential requirements).
- 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
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure
Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality
Why Join Crest Solutions?
At Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Crest Solutions benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:
- Competitive salary.
- Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme.
- A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment.
- A structured approach to professional development opportunities with an educational assistance program.