Quality Technician

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 30,000 - 50,000; Full time

Job summary

Quasar Medical in Ireland is seeking a Quality Technician to support the quality system across manufacturing and product engineering, ensuring compliance with ISO13485, MDD 93/42/EEC and FDA QSR where applicable. You will review batch records, issue Certificates of Conformance and assist CAPA and internal audits.

The role emphasizes problem solving, process improvements, and collaboration with operations, QA and suppliers to maintain product quality and regulatory readiness.

Qualifications

• Experience in Medical Device industry is essential or highly desirable.
• 2–5 years of relevant experience in quality roles.
• Strong analytical and problem-solving abilities; able to influence improvements.

Responsibilities

• Review batch records and approve release of product and issue COCs/COAs.
• Support compliance with quality system requirements (ISO13485, MDD 93/42/EEC, FDA QSR).
• Assist CAPA investigations and internal/external audits.
• Support investigations into product defects and customer complaints.
• Participate in lean and cost-reduction activities.
• Maintain documentation for Site Production Department.

Skills

Interpersonal skills

Multi-tasking

Self-starter

Analytical thinking

Advanced communication

Cross-functional collaboration

Influence & change driving

Tools

IFS

SAP

Oracle

Job description

The Quality Technician has responsibility for the effectiveness of assigned areas of the company’s quality system. Provides support to the operations function and incoming. Maintain records in accordance with the quality system requirements, which show that products manufactured by Quasar meet the requirements of end users, customers, regulatory authorities and the company. Maintain assigned areas of the Quasar Medical quality system in accordance with the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations (if applicable)

Essential Job Duties and Responsibilities

General Duties

• Provides support to Manufacturing and Product Engineering and Quality Engineers for comercial/validation projects.
• Supports implementation and maintenance of manufacturing methods, processes and operations for new and existing products.
• Supports dispositions of nonconforming material and processes.
• Supports sustaining Engineering and QE in resolving Manufacturing issues in the plant.
• Participate in lean and cost reduction activities.
• Supports the conduct of investigations and associated actions related to CAPA and Internal/external audit activities.
• Supports investigations and associated actions related to customer complaints.
• May assist designated auditors in the performance of site internal audits.
• May support execution/hosting of external audits
• Supports maintenance of Quality System implementation.

Specific Duties and Responsibilities

• Review batch records and approve release of product. Provide accurate Certificates of Conformance and/or Certificates of Analysis.
• Effectively communicate with other staff, customers and suppliers in order to promote quality awareness and to conform to customer requirements.
• Identify areas for improvement and lead improvement initiatives.
• Provide continued support for CER operations.
• Investigate, troubleshoot and report on system failures and product defects. Champion a structured approach to problem solving within process improvement teams.
• Investigate product returned from customers or product under non-conformance. Complete investigation reports.
• Maintain control of documentation relating to the Site Production Department.
• Conduct Incoming Inspections as and when required on specific materials.

Other duties may be assigned as the person matures within the position.

Education and Experience Requirements

• It is desirable that the Quality Technician should have a good level of education with strong experience in a Medical Device industry and working within Controlled Environments.
• Experience in medical device is essential, two (2) to five (5) years
• Good interpersonal skills and have the ability to multi-task
• Must be motivated and demonstrate the ability to be a self-starter.
• Excellent communication skills with ability to interface at all levels.
• Should have strong analytical, organizational and influencing skills.

Preferred Skills and Abilities

• Experience with ERP systems (e.g., IFS, SAP, Oracle).
• Familiarity with advanced manufacturing technologies.
• Strong interpersonal skills – holding team accountable, emotional intelligence.
• Self-starter with strong organizational skills and high degree of accuracy and detail.
• Excellent interpersonal and communication skills with the ability to work effectively with all levels of employees, suppliers, and customers.
• Ability to influence, negotiate and drive changes.
• Basic understanding of various balloon catheter manufacturing methods
• Basic knowledge of Lean Manufacturing environment
• Knowledge of basic problem solving skills, such as DMAIC and PDCA
• Other skills that may be required or learned on the job: