Primary purpose and function of this position:
In this role, the QA Device Engineer support products development and manufacturing processes and provide quality oversight to device projects while working within a multi-functional team environment for medical devices.
The QA Device Engineer to be involved in projects and tasks, from design and development, through design transfer, production process establishment and changes and to play an active role to ensure that design and processes meet all applicable quality standards, consistent with internal procedures and acceptance criteria, while meeting all design and process control and applicable regulatory requirements. The QA Device Engineer will support continuance improvement of device, process and QMS and provide guidance and support to all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards.
Major duties and responsibilities:
· QA focal point for Device projects in the design and development processes
· Ensure Device to be compliant to US and EU regulations.
· Provide guidance on design, technical and engineering processes/documentation to ensure compliance to procedures, relevant regulations and standards.
· Responsible for review and approve device development DHF documentation (device specifications, design verification & validation activities, risk documents, test methods, protocols, reports, out of specification, design transfer, etc.) in relation to medical device.
· Responsible for review and approve process validation/qualification documentation (DMR, IQ, OQ, PQ, risk documents, test methods, protocols, reports, deviations, incoming inspections and release of product to clinical trials and commercial product to the market, etc.) in relation to medical device manufacturing.
· Responsible for review and approval of product design and manufacturing process change controls.
· Act as QA representative in product and processes development design reviewes.
· Provide direction and guidance with problem solving techniques for technical and design review activities.
· To work closely with the Device Department and the relevant functions.
· Work cross-functionally with other individuals and project team leaders to provide QA guidance and ensure success of projects.
· Support QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, internal/external audits, or Other duties as assigned.
Reports To: QA Device Director
Competencies:
· Ability to work under pressure.
· Good interpersonal and written and oral communication skills.
· Strong analytical and problem solving ability.
· Orderly and organized person.
· Quick learner.
Education and Knowledge Requirements:
· B.Sc. in Engineering or Science required
· Minimum 5 years working in Medical Device / Pharma industry- in Quality roles
· Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities – Advantage
· Experience in Equipment Validation, Process Validation and Change Control Process.- Advantage
· Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971
Note: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position may be considered.
