Design Quality EngineerVantage MedTech • Lenexa, KS, US
Design Quality Engineer
Vantage MedTech • Lenexa, KS, US
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job_description.job_card.job_descriptionDevelop and maintain comprehensive expertise in the FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 14971, applicable pertinent regulations and standards, and internal QMS requirements. Provide project-level Quality oversight throughout the PRP (Product Realization Process) through participation in cross-functional design reviews, risk management activities, and verification and validation activities to ensure the design meets regulatory standards / QMS requirements and is fit for its intended use. Support maintenance and audit of the entire Design History File (DHF) & Device Master Record (DMR), ensuring product deliverables are ready for release and external audits. Contribute to risk management and assessments including failure mode, effects analysis (FMEA), and system hazard analysis (SHA) to identify potential issues and implement mitigation strategies. Facilitate the application of design / change controls and risk management mitigation actions. Conduct reviews and approvals of records such as Engineering Change Order (ECO) processes (and DCOs when required) ensuring compliance. Provide feedback to the teams on expectations for compliance using FDA, FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 14971, and internal QMS requirements. Prepare and support internal and external audit preparation and execution. Analyze quality and design data to identify areas for improvement and drive continuous improvement initiatives of the quality management system (QMS) and processes. Participate in and champion Corrective and Preventive Action (CAPA) investigations. Support and provide required data for periodic management reviews. Support regulatory submissions and collaborate with regulatory team for input. Assist in the preparation of necessary documentation for regulatory submissions, such as those required by the FDA. Other duties as assigned. Bachelor's degree in Engineering. 1-3 years' related experience in a regulated work environment, preferably medical device. Skilled problem solver with experience and desire to work in a collaborative team environment. Excellent oral and written communication, organizational, attention to detail, and teamwork skills are required. Proficient in Microsoft Office tools. Ability to respond quickly to shifting priorities and to meeting deadlines with a sense of urgency. Takes initiative and proactively seeks quality solutions through continuous improvement. Comprehensive benefits package, including health, vision, and dental insurance. Generous Paid Time Off. Company retirement plan with matching.
Job Title : Design Quality Engineer
Location : Lenexa, KS
Department : Quality Assurance
Reports to : Director of Quality and Regulatory
Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We develop and manufacture new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide.If this is something you aspire to, we would like to talk with you!
Vantage MedTech is seeking a Design Quality Engineer to serve as the cornerstone of Quality Assurance in cutting-edge design projects, ensuring they meet the highest standards of excellence and compliance. This role is responsible for maintaining alignment with the Vantage MedTech Quality Management System and design control processes, acting as the QA representative on assigned projects. This individual will enhance the capabilities of the design engineering team by overseeing the maintenance and compliance of the Design History File (DHF), Device Master Record (DMR), and document control processes, while upholding compliance assurance for external partners.
- This is not a remote opportunity. This position is based in Lenexa, KS. Local candidates only. We do not offer relocation assistance.
Key Responsibilities :
Education and Experience :
Top Benefits / Perks :
As a team member at Vantage MedTech, you'll enjoy :
Vantage MedTech values a diverse team and is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States. For more information, visit www.vantagemedtech.com
No third-party candidates please.
J-18808-Ljbffr
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Quality Engineer • Lenexa, KS, US
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