Quality Engineer III at Nissha

Prague, Prague, Czechia -

Full Time

Start Date

Immediate

Expiry Date

18 Jun, 26

Salary

0.0

Posted On

20 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality System Regulations, Manufacturing Transfer, Development Projects, Test Method Validations, First Article Inspections, Control Plans, PFMEAs, Component Qualification Plans, Lean, Six Sigma, Process Improvements, Customer Quality Requirements, Process Audits, Statistical Techniques, Minitab, cGMP

Industry

Medical Equipment Manufacturing

Description

ESSENTIAL DUTIES AND RESPONSIBILITIES (Other duties may be assigned) • Adhere to employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies’ practices, policies, and Standard Operating Procedures to ensure compliance with customer requirements, industry standards, and regulations. • Perform and support the timely completion of deliverables related to manufacturing transfer and/or development projects. • Support the establishment of quality standards for products, processes, and procedures. • Conduct Test Method Validations (TMVs) and First Article Inspections (FAIs) for components. • Develop Control Plans and PFMEAs. • Develop, coordinate, and execute component qualification plans (SSRs). • Lead Lean/Six Sigma projects for product/process improvements. • Implement process improvements, including fixtures, tooling, production controls, testing, and inspection devices. • Act as the primary interface for all customer quality requirements during project activities and process audits. • Review documentation and standards relevant to product production and development. • Investigate, analyze, and document quality issues detected during project development. • Participate in internal audits, as well as audits conducted by regulatory agencies and Notified Bodies. • Serve as a backup for other departmental functions as needed. • Comply with all safety standards established by the company and regulatory agencies. • Regular attendance is required. MINIMUM QUALIFICATIONS • Industrial Engineer (preferred) or related field • 5 to 7 years of related experience (Medical Devices preferred) • Familiarity with Quality Systems and regulatory agencies; preferably ISO 13485 and FDA 21 CFR 820 • Advanced English proficiency • Proficiency in statistical techniques; experience using Minitab • Knowledge of Current Good Manufacturing Practices (cGMP) • Experience in establishing and maintaining Quality Systems • Experience with ISO and/or FDA audits (preferred) • Certification as a CQE, CSSGB, or CSSBB (preferred)

Responsibilities

This role is responsible for executing activities related to the implementation and maintenance of the Quality System for manufacturing transfer and development projects. Key duties include performing validations, developing quality documentation, leading improvement projects, and serving as the primary quality interface for customer requirements.