We are looking for a Design Control Manager to join our rapidly growing team. You will play an essential role in reviewing, and approving design & development, design changes, and implementation (production) processes, executing risk-based product controls.
You will be the contact person for quality-related issues for the different R&D teams and closely work with V&V / SQA, R&D, Project leads, and Product.
You have solid experience with working in the crossing between RA R&D QA and are comfortable ensuring compliance in the teams projects where the focus will be on Design Control.
The position will also encompass related areas of responsibility such as supporting work with CAPA, implementing new standards, and participating actively in audits.
You will be the contact person for quality-related issues for the different R&D teams and closely work with V&V / SQA, R&D, Project leads, and Product.
You have solid experience with working in the crossing between RA R&D QA and are comfortable ensuring compliance in the teams projects where the focus will be on Design Control.
The position will also encompass related areas of responsibility such as supporting work with CAPA, implementing new standards, and participating actively in audits.
Requirements:
Ensure the proper implementation of the SDLC process according to IEC 62304, the quality of the documentation (review and approval ) in the project, that is compliance with the regulatory requirements
Support SW production/release documentation and ECO
Provide Quality support at various stages of Product Development and coaches others in analysis and decision making
Ensuring that R&D procedures and work instructions are continuously up-to-date and effective
Lead Risk Management processes according to ISO 14971
Provides the quality/independent review at defined design reviews and project design plans, for new development projects as well as design/process changes
Support the implementation of eQMS systems and quality tools used in the development process, including documentation, testing, and monitoring of the product
Keeps up to date on all ISO/FDA/MDR and other Product Development related regulatory requirements and relays this information to the Product Development group
Qualifications:
Bachelors degree in Engineering or related field, such as Engineering, Computer science, etc
5 years of related experience in the medical device, experience with the development of Multidisciplinary products or SaMD
Expert understanding of appropriate global medical device regulations, requirements, and standards, including Quality Management System ISO 13485/ QSR / MDR, SDLC IEC 62304, and Risk Management ISO 14971
Familiar with cybersecurity and privacy standards and regulations, such as ISO 27001:2013 an advantage
At least 5 years of experience as a QMS Specialist/Manager
Certified Quality Engineer (CQE / CQM) an advantage
Certified Internal Auditor an advantage
Project Management (development of project plans, status meetings, project reporting, etc) and organizational change movement
Ability to communicate perfectly in English both orally and in writing
Self-motivated and able to manage time working on multiple projects simultaneously
Tech Savvy Demonstrated competency in computer skills
Must be able to communicate appropriately and adequately to all management levels
Ensure the proper implementation of the SDLC process according to IEC 62304, the quality of the documentation (review and approval ) in the project, that is compliance with the regulatory requirements
Support SW production/release documentation and ECO
Provide Quality support at various stages of Product Development and coaches others in analysis and decision making
Ensuring that R&D procedures and work instructions are continuously up-to-date and effective
Lead Risk Management processes according to ISO 14971
Provides the quality/independent review at defined design reviews and project design plans, for new development projects as well as design/process changes
Support the implementation of eQMS systems and quality tools used in the development process, including documentation, testing, and monitoring of the product
Keeps up to date on all ISO/FDA/MDR and other Product Development related regulatory requirements and relays this information to the Product Development group
Qualifications:
Bachelors degree in Engineering or related field, such as Engineering, Computer science, etc
5 years of related experience in the medical device, experience with the development of Multidisciplinary products or SaMD
Expert understanding of appropriate global medical device regulations, requirements, and standards, including Quality Management System ISO 13485/ QSR / MDR, SDLC IEC 62304, and Risk Management ISO 14971
Familiar with cybersecurity and privacy standards and regulations, such as ISO 27001:2013 an advantage
At least 5 years of experience as a QMS Specialist/Manager
Certified Quality Engineer (CQE / CQM) an advantage
Certified Internal Auditor an advantage
Project Management (development of project plans, status meetings, project reporting, etc) and organizational change movement
Ability to communicate perfectly in English both orally and in writing
Self-motivated and able to manage time working on multiple projects simultaneously
Tech Savvy Demonstrated competency in computer skills
Must be able to communicate appropriately and adequately to all management levels
This position is open to all candidates.
