Quality Engineer – Validation, FMEA, Regulatory Compliance, Medical Devices

Jobtailor; Vilters-Wangs; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a Quality Development Engineer in the Swiss canton of St. Gallen to support commercial production quality activities.

You will ensure compliance with ISO 13485, EU MDR, FDA regulations, and participate in audits, validation, CAPA, and risk management using Minitab and DOE. Fluent German and English are mandatory, and collaboration across multidisciplinary teams is essential.

Qualifikationen

• Bachelor's degree in an engineering discipline; Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Eng preferred.
• Experience in the medical device industry or regulated environment.
• Knowledge of ISO 13485, ISO 14971/24971, EU MDR.
• Hands-on validation activities (IQ/OQ/PQ), statistical tools, and CAPA processes.

Aufgaben

• Support all quality development activities for commercial production.
• Ensure compliance with internal procedures, FDA regulations, and ISO 13485, EU MDR.
• Serve as quality subject matter expert during audits.
• Lead validation (IQ/OQ/PQ) and CAPA processes.
• Perform statistical analyses using Minitab and DOE to determine process capability.

Kenntnisse

Fluent German

Fluent English

Analytical skills

Problem-solving

Process-oriented

Attention to detail

Ausbildung

Bachelor's degree in engineering

Tools

Minitab

DOE

MS Office (Word)

Jobbeschreibung

• Support all quality development activities for commercial production
• Ensure compliance with internal procedures, FDA regulations, and applicable international standards including ISO 13485, EU MDR, and ASTM
• Serve as quality subject matter expert during regulatory and internal audits
• Support validation and re-validation of test methods and manufacturing processes
• Develop, review, and approve protocols and reports for test method validation
• Implement IQ, OQ, and PQ process qualification activities, including protocol and report review
• Collaborate cross-functionally with Manufacturing Engineering on design, production, and user FMEAs
• Create, maintain, and approve risk management documents in line with ISO 14971/24971
• Lead and support CAPA processes, including root cause analysis, problem-solving methodologies, and corrective/preventive action implementation
• Perform statistical analyses to determine process capability indicators using Minitab and DOE
• Support the Manufacturing Engineering team across quality-related tasks

Requirements

• Bachelor's degree in an engineering discipline, preferably Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Engineering
• Experience in the medical device industry or a comparable regulated environment
• Practical knowledge of ISO 13485, ISO 14971/24971, EU MDR
• Hands-on experience with validation activities (IQ/OQ/PQ), statistical tools, and CAPA processes
• Fluent in German and English, written and spoken (mandatory)
• Strong analytical and problem-solving skills
• High level of accuracy and process-oriented working style
• Proficient in MS Office, especially Word
• Knowledge of DOE and Minitab statistical software
• Comfortable working in multidisciplinary, international teams

Core Competencies

Demonstrates expertise in quality development activities, ensuring compliance with FDA regulations and international standards such as ISO 13485 and EU MDR. Proficient in validation processes, statistical analysis, and risk management within the medical device industry.

Highest-signal resume keywords

• ISO 13485 Compliance
• Validation Activities (IQ/OQ/PQ)
• Statistical Analysis (Minitab, DOE)
• CAPA Processes
• Fluent in German and English

Hard Skills

• Quality Development
• Test Method Validation
• Process Qualification
• Root Cause Analysis
• Statistical Analysis
• Risk Management
• Problem-Solving Methodologies
• Regulatory Compliance
• Manufacturing Processes
• FMEA

Soft Skills

• Analytical Skills
• Problem-Solving Skills
• Process-Oriented Working Style
• Collaboration
• Attention to Detail

Industry Keywords

• Medical Device Industry
• FDA Regulations
• ISO 14971/24971
• EU MDR
• Regulated Environment

Tools & Technologies

• Minitab
• DOE
• MS Office (Word)