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Performs activities related to the support of all established quality system, product release cGMP compliance requirements in the assigned area of the facility.
Conducts process monitoring and supports adherence to quality standards of products, processes, and areas.
Shift Quality Technician on a front line manufacturing team delivering on customer focused quality decisions in real time.
Ensures effective and efficient handover to rotating shift team members.Ensures adherence to quality plans and conducts final review of batch documentation, including release of product on the MIS system.Monitors area housekeeping programs to ensure standards are maintained and records are completed and compliant.Develops, implements, and monitors visual standards to meet customer specifications.Drives adherence to quality standards and the application of risk-based decisions, using tools such as PFMEA and risk assessment.Generates and reviews temporary deviations, process, and rework instructions.Troubleshoots quality issues within manufacturing.
Applies systematic problem-solving methodologies such as DMAIC and process mapping.
Utilizes appropriate statistical tools such as SPC in identifying, prioritizing, and resolving issues.Monitors and analyzes data to ensure adherence to standards and identifies opportunities to improve processes and procedures to eliminate waste and maintain quality.Participates in New Product Introductions, Continuous Improvement projects, and initiatives.Maintains Visual Management boards, quality metrics, reporting systems, and prepares required reports.Conducts internal quality audits to ISO and GMP requirements and supports supplier, customer, and regulatory audits.Develops and provides training, including GMP training programs.Supports quality on cross-functional teams working on process change review and assessment prior to implementation.Completes assigned actions related to customer complaints, risk assessments, NC containment, investigations, and CAPA implementation.Supports validation activities ensuring compliance with relevant quality standards and regulatory requirements.Participates in project work as assigned.Ensures full compliance with GDP & GMP requirements.Adheres to Quality and EHS policies and procedures at all times.Supports sterile product batch record compilation, review, and signoff for routine commercial sterile loads, including prescribed testing such as residual data, bioburden, LAL, and cycle conditions.Supports selection of products for testing where applicable and ensures documentation is completed to standard.
Education / Experience RequirementsDiploma 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 ability to apply them in manufacturing.Excellent attention to detail and GDP.Experience in a hands-on line support role is highly desirable.Good understanding of problem-solving and statistical methodologies; Yellow belt level is desirable.Excellent computer skills (Word, Excel, PowerPoint).Excellent verbal and written communication and interpersonal skills.Specialized Skills / Other RequirementsCustomers and Vendors Ability to understand customer relationships.Ability to generate appropriate relationships with customers.Ability to handle difficult customer communications.People Clear verbal and written communication skills.Ability to work in a cross-functional team.Interpersonal skills to resolve day-to-day issues effectively.Demonstrates behaviors aligned with Teleflex Core Values.
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