Sr. Engineer – Q.A. (Validations)

SectorMedical Technology


Location: Just outside of Hamburg
Title: Sr. Engineer – Q.A. (Validations)
Department: Quality Management
Reports to: Team Lead Q.A.
Language: English (Essential), German (B1, basic)    

Primary Tasks and Responsibilities
•    Responsible for supporting R&D team during initial Process Validation and Qualification activities 
•    Responsible for Process revalidation including, drafting of protocol, identification of sample size, test method and reports including validation of risk controls as outcome of Risk Management Process in compliance with ISO 14971
•    Software Validation
•    Supporting Production and Maintenance departments during Operational

•    Responsible for process validation planning & execution
•    Responsible for using statistical techniques for statistical process control, process validation and process data analysis using MiniTab
•    Responsible for customer account handling for understanding customer needs and coordinating with different departments to implement the needs
•    Responsible for ensuring compliance with applicable international standards and regulatory requirements for validation as well as compliance with internal QMS requirements for validation 
•    Collaboration with cross functional departments for performing process FMEA.

Skills / Competencies
•    Prior quality engineering experience in the medical device 
•    Excellent verbal and written communication skills, teamwork skills, attention to detail and results orientation required
•    Effective troubleshooting and problem solving skills
•    Ability to work both independently and in conjunction with a team
•    Knowledge of Quality System Standards/Regulations (ISO 13485, 21CFR Part 820, MDD93/42/EEC, ISO 14971, WHO GMP etc)
•    Experience in the use of statistical tools (SPC, Six Sigma, MiniTab etc.)

Working conditions
•    Permanent, full time (40 hrs / week)

Any specific skill requirements
•    USFDA exposure

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