Quality Technician

3 weeks ago

Cork, Cork, Ireland Teleflex Full time
Position Summary

Title: Quality Technician - Swing Shift

Reports to: Senior Quality Engineer

Department: Quality

Purpose Of The Role

Performs activities related to supporting the established quality system, product release, and cGMP compliance requirements in the assigned area of the facility. Conducts process monitoring and supports adherence to quality standards of products, processes, and areas.

Principal Responsibilities
  • Serve as Shift Quality Technician on a front-line manufacturing team, making customer-focused quality decisions in real time. Ensure effective handover to rotating shift team members.
  • Ensure adherence to quality plans and conduct final review of batch documentation, including product release on the MIS system.
  • Monitor area housekeeping programs to maintain standards, ensuring records are complete and compliant.
  • Develop, implement, and monitor visual standards to meet customer specifications.
  • Drive adherence to quality standards and apply risk-based decisions using tools like PFMEA and risk assessments.
  • Generate and review temporary deviations, process, and rework instructions.
  • Troubleshoot quality issues within manufacturing using systematic problem-solving methodologies such as DMAIC and process mapping. Utilize statistical tools like SPC to identify, prioritize, and resolve issues.
  • Monitor and analyze data to ensure standards are met and identify opportunities for process improvements to eliminate waste and maintain quality.
  • Participate in New Product Introductions, Continuous Improvement projects, and initiatives.
  • Maintain Visual Management boards, quality metrics, reporting systems, and prepare reports.
  • Conduct internal quality audits to ISO and GMP standards and support audits from suppliers, customers, and regulatory bodies.
  • Develop and deliver training, including GMP training programs.
  • Support cross-functional teams in process change reviews and assessments prior to implementation.
  • Complete actions related to customer complaints, risk assessments, NC containment, investigations, and CAPA implementation.
  • Support validation activities ensuring compliance with relevant quality standards and regulations.
  • Participate in project work as assigned.
  • Ensure full compliance with GDP and GMP requirements.
  • Adhere to Quality and EHS policies and procedures at all times.
  • Support sterile product batch record compilation and review, including all prescribed testing such as residual data, bioburden, LAL, and cycle conditions.

Support selection of products for testing and ensure documentation is completed to standard.

Education / Experience Requirements
  • Diploma in Quality, Engineering, Science, or equivalent qualification.
  • Minimum 4 years industry experience in a medical device manufacturing environment or similar.
  • Knowledge of quality principles and their application in manufacturing.
  • Excellent attention to detail and GDP awareness.
  • Experience in a hands-on line support role is highly desirable.
  • Good understanding of problem-solving and statistical methodologies; Yellow belt level is desirable.
  • Proficient in Word, Excel, PowerPoint.
  • Excellent verbal and written communication and interpersonal skills.
Specialized Skills / Other RequirementsCustomers and Vendors
  • Ability to understand customer relationships and generate appropriate interactions.
  • Capability to handle difficult customer communications.
People
  • Clear verbal and written communication skills.
  • Ability to work in cross-functional teams.
  • Use interpersonal skills to address daily people-related issues.
  • Demonstrate behaviors aligned with Teleflex Core Values.
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