The Mullings Group
Design Quality Engineer
The Mullings Group, Raleigh, North Carolina, United States, 27601
Our client is a rapidly growing player in the medical robotics arena with a mission to digitizes the interface between the surgeon and the patient to improve minimally invasive surgery through digital laparoscopy.
We are searching for a Design Quality Engineer to join the Design and Operations Quality team, which is part of the Global Quality team. This role will be responsible for conducting activities associated with product support and product development processes at the company globally from a Quality perspective, to provide a compliant, safe and effective product that meets customer needs.
Activities include generation and management of SOP’s, generation and review of documentation, audits, participation in process improvement programs, supporting the product development teams ensuring the quality objectives are understood and achieved. The Quality Engineer shall ensure that mechanical, electrical, and software systems used in development, manufacturing and as part of medical devices are established according to requirements.
Key Responsibilities:Participates in Design Control/Assurance activities globally; assists in the development of design concepts, prototypes and product specifications as part of the development team.Provides guidance to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles.Acts as a key contributor in writing and reviewing protocols, reports, work instructions, and SOPs to support product and process development.Defines and develops risk management activities including creation and maintenance of risk management files by product and process.Supports Design Transfer activities including Supplier Qualification and Development activities.Builds and maintains a strong and impactful relationship with global R&D for Design quality aspects.Participates within the design change process by assisting with development and documentation of impact analyses related to design, process, suppliers, etc.Supports improvements to QMS as a result of quality events, audits or regulatory changes to ensure compliance with FDA 21 CFR 820, ISO 13485, and adoption of best practices.Supports internal audits and CAPA activities as applicable.Ensures compliance with company quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.All other duties as directed.
Qualifications:Bachelor’s degree in Biomedical or Electrical engineering. Master’s degree in engineering discipline preferred.2+ years in a quality engineering role in the Medical Device field.Some knowledge of key standards/regulations related to medical device manufacturing, including but not limited to ISO 13485, 21 CFR Part 820, MDSAP, ISO 14971, and EU MDR 2017/745.Some experience and understanding of design control, disciplined product development processes, regulatory, and quality requirements.Some knowledge of common quality and statistical tools.Experience working in cross-functional teams.
For more information visit: https://briefs.mullingsgroup.com/position/asensus-surgical-design-quality-engineer/
We are searching for a Design Quality Engineer to join the Design and Operations Quality team, which is part of the Global Quality team. This role will be responsible for conducting activities associated with product support and product development processes at the company globally from a Quality perspective, to provide a compliant, safe and effective product that meets customer needs.
Activities include generation and management of SOP’s, generation and review of documentation, audits, participation in process improvement programs, supporting the product development teams ensuring the quality objectives are understood and achieved. The Quality Engineer shall ensure that mechanical, electrical, and software systems used in development, manufacturing and as part of medical devices are established according to requirements.
Key Responsibilities:Participates in Design Control/Assurance activities globally; assists in the development of design concepts, prototypes and product specifications as part of the development team.Provides guidance to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria and statistical principles.Acts as a key contributor in writing and reviewing protocols, reports, work instructions, and SOPs to support product and process development.Defines and develops risk management activities including creation and maintenance of risk management files by product and process.Supports Design Transfer activities including Supplier Qualification and Development activities.Builds and maintains a strong and impactful relationship with global R&D for Design quality aspects.Participates within the design change process by assisting with development and documentation of impact analyses related to design, process, suppliers, etc.Supports improvements to QMS as a result of quality events, audits or regulatory changes to ensure compliance with FDA 21 CFR 820, ISO 13485, and adoption of best practices.Supports internal audits and CAPA activities as applicable.Ensures compliance with company quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.All other duties as directed.
Qualifications:Bachelor’s degree in Biomedical or Electrical engineering. Master’s degree in engineering discipline preferred.2+ years in a quality engineering role in the Medical Device field.Some knowledge of key standards/regulations related to medical device manufacturing, including but not limited to ISO 13485, 21 CFR Part 820, MDSAP, ISO 14971, and EU MDR 2017/745.Some experience and understanding of design control, disciplined product development processes, regulatory, and quality requirements.Some knowledge of common quality and statistical tools.Experience working in cross-functional teams.
For more information visit: https://briefs.mullingsgroup.com/position/asensus-surgical-design-quality-engineer/