We are seeking a skilled Manufacturing/Process Engineer to join the team of a leading contract manufacturer specializing in implants for orthopedics and traumatology in Holland, Michigan. In this role, you will play a crucial part in the planning and execution of qualifications and validations for production facilities and manufacturing processes in compliance with management systems such as EN ISO 13485 and 21 CFR Part 820.
Responsibilities:
As a Manufacturing/Process Engineer, you will be responsible for the targeted planning and implementation of qualifications and validations for production facilities and manufacturing processes. Your duties include:
Planning and executing qualifications and validations in compliance with management systems (EN ISO 13485, 21 CFR Part 820), while creating relevant documents adhering to quality standards.
Evaluating change requests/deviations related to qualification and validation requirements and implementing necessary measures.
Directly engaging with customers to approve changes and coordinating their implementation in production.
Conducting risk analyses in accordance with ISO 14971.
Overseeing the implementation of (re)validations and ensuring process compliance.
Performing process capability studies and preparing statistical evaluations as part of validations.
Coordinating validation participants and activities within validation projects.
Serving as the contact person for qualification and validation topics during audits.
Undertaking independent tasks within the framework of project management, potentially up to project management.
Supporting the introduction of new processes and their documentation in our quality management system.
Requirements
To thrive in this role, you should possess:
A completed degree in medical technology, mechanical engineering, process engineering, or a related technical field.
Desirable background in metalworking.
Several years of professional experience in validation and medical technology.
Knowledge of regulatory requirements, particularly in qualification, validation, and manufacturing guidelines for medical devices (DIN ISO 13485, 21 CFR Part 820, GMP Annex 15, DIN EN ISO 14971).
Desirable knowledge in the validation of computerized systems and software (21 CFR Part 11, GMP Annex 11, GAMP 5).
Strong communication and teamwork skills, coupled with discipline, assertiveness, and a structured, solution-oriented approach.
Proficiency in MS Office and familiarity with statistical methods (e.g., Minitab).