Medical Device jobs in Galway, County Galway

Job Title: Quality Technician

Location: Ballybrit Upper Industrial Estate, Monivea Rd Galway H91 XP49

Reports to: Senior Quality Engineer

Job Summary

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).

The working week is a 4-day week from Monday- Thursday 7am -5.15pm on-site in a cleanroom and controlled manufacturing environment.

Essential Job Duties and Responsibilities

General Duties

• Provides support to Manufacturing and Product Engineering and Quality Engineers for commercial/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.
• Excellent computer 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:

• MS Office suite & MS Project
• Minitab

Working knowledge associated with:

• Knowledge of ISO13485 requirements
• GMP & FDA 21CFR:820 requirements
• Controlled environment per ISO 14644-X
• ISO 14971
• QMS Auditor

Equal Opportunity Statement

Quasar Medical provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, colour, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

Job Types: Full-time, Fixed term
Contract length: 12 months

Benefits:

• Company pension
• Private medical insurance

Work Location: In person