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Position Title: Design Quality Engineer II
Reports To: Manager - Design Quality
General Summary
Position Title: Design Quality Engineer II
Reports To: Manager - Design Quality
General Summary
Design Quality Engineer is responsible for providing Design Quality Assurance support for projects within product families across the full product lifecycle. It will be New Product Development support, Sustaining Engineering and Life Cycle support. This role will plan and execute design control activities for all projects and requires judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criterions. Responsibilities will include adherence to design controls, quality planning, risk management/analysis/ assessments, design reviews, test method approvals, design & process verification and validation activities. You will play an important role in reviewing and approving design changes and in developing/improving risk-based product controls.
·Responsible for Review and Approval of SOPs, WI’s, QMS documents, protocol and reports pertaining to Research and Development activities and its compliance.
·Responsible to provide Quality support at various stages of Product Development.
·Generate and review quality plans, risk documents (Hazard Analysis, FMEA’s, etc), product specifications, design verification and validation and other applicable in conformance with Intuvie Quality Management system and with compliance to FDA and other notified body requirements.
·Responsible for resolving development related product quality issues with Cross functional teams’ cooperation.
·Drives the development of product requirements, verification and validation strategies and generates Product Development Reports and relevant data.
·Facilitate, participate in and/or lead formal risk assessments and support the risk management process per ISO 14971 and ensures Risk management File is maintained to state of art.
·Work cross functionally to ensure necessary design controls activities are followed for design changes.
·Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance.
·Develop statistically sound sampling plans and perform data analysis
·Participate in analysis of complaints and post market surveillance data and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
·Participate in Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process
·Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
·Drive continuous improvement initiatives related to design quality, processes, tools and methodologies.
Essential Job Functions
In this position you will be the contact person for quality-related issues for PMO, R&D and other internal stakeholders. Additionally, you will closely work together with QA-colleagues, R&D, project leads and production. You will issue QA documents with sponsors, review the analytical methods/ results, production records, and qualification as well as validation protocols and reports and participate in other QA tasks as needed.
Preparation, Knowledge, Skills & Abilities
·Bachelor’s degree in engineering or related field, plus a minimum of 3 years of related experience in the medical device or another regulated industry
·Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must
·Detailed knowledge of Design Controls, Change Controls, GxP, Medical Device FDA Regulations, ISO 14971, ASME, ASTM and other relevant standards.
·Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change movement
·Ability to analyze information and come to conclusions based on presented data
·Ability to communicate effectively both orally and in writing
·Self-motivated and ability to manage time working on multiple projects simultaneously
·Demonstrated competency in computer skills: MS office applications, Statistical Tools, QMS and PLM software’s is a plus
·Must be able to communicate appropriately and adequately to all management levels, including group presentation experience
·This job description is not all inclusive and is intended to capture a majority of the job functions.Special projects and other tasks may be required by management.
Working Conditions/Physical Demands
Normal business office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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