We are seeking a Senior Quality Engineer to join our clients team!
Responsibilities
KPI's
* QMS and maintaining it in an "Audit Ready" state.
* Owning CAPAs
* Internal quality training.
* Data Integrity.
* Change Control & Change Management process.
* Capability to review client URS requirements, complete a gap analysis between the URS and Design Specifications, and maintain an RTM throughout the Design Specification development cycle.
* Preparation of document packs for review at defined Design Gates.
* Creation and execution of FAT, commissioning & SAT protocols.
* Preparation of package turnover over documentation.
Validation / Commissioning Qualification
* Responsible for the creation of validation exercise documentation including validation protocol (DQ, IQ,OQ,PQ) and master validation plan.
* Coordinate execution of validation activities, work closely with Operations team and related parties to meet validation timeline.
* Review validation protocols and test report to ensure that they are technically correct.
* Ensure validation plan and reports are meeting regulatory requirements.
* Anticipate problems actively and take appropriate action to mitigate impact.
* Responsible for the tracking and managing the resolution of issues generated during validation.
* Manage approval of validation documentation by internal approvers and customers in a timely manner.
* Ensure validation protocols and test reports are properly documented.
* Work closely with the rest of the validation team members and provide an emphasis on quality and validation best practices.
* Follow and submit to best practice in relation to a clearly documents and audit friendly validation process.
* Ensure validation documentation is always audit ready.
General
* Providing timely status and updates to management as required.
* Take responsibility for being quality gateway for your own deliverables.
* Line review and verification against the Master Validation Plan(MVP) to ensure all validation activities are properly and completely documented and updating of the MVP in a timely manner such as when there are new validation activities and changes to existing validation.
* Other duties and assignments as instructed by superiors from time to time.
* To comply to all requirements of ISO (inclusive of all standards approved by the Management) and to adhere to general safety practices, standard operating procedure, work instructions, policies and guidelines provided by the company.
Requirements:
* Bachelor's Degree in Mechanical, Mechatronic/Electromechanical or equivalent years of related experience.
* Minimum of 2-5 years of working experience in Medical related field.
* Preferably with good knowledge in ISO 13845, ISO9001,FDA 21CFR Part and GAMP5.
* Medical device technical writing and validation/qualification for the processes, systems and equipment.
* Experience in Computerized System Validation will be an added advantage.
* Ability to work independently and be self-sufficient while managing multiple projects.
* Initiative, proactive, able to work in a team and under minimum supervision.
