Job ID: JOB_ID_185
Position Summary
As a Senior Design Quality Engineer in Plano, Texas, you will play a pivotal role in ensuring that new and modified medical device products meet the highest standards of quality, safety, and regulatory compliance. This onsite contract position requires a dedicated professional who can navigate the complexities of the medical device regulatory landscape while maintaining a strong collaborative partnership with cross-functional development teams. Your work will directly impact patient safety and the overall success of the organization’s product portfolio by ensuring that every design choice is backed by rigorous testing and documentation.
Core Responsibilities
- Serve as the primary quality representative on product development teams, promoting and assuring quality throughout the project lifecycle.
- Execute and oversee the completion of Design Control deliverables for New Product Development (NPD) and Design Change projects.
- Collaborate with engineering and clinical teams to define, assess, and verify Design Input requirements and Design Outputs.
- Lead Design Verification and Design Validation activities to ensure products meet user needs and intended uses.
- Support the establishment of objective, measurable, discrete, and verifiable product requirements.
- Manage equipment qualification, inspection method development, and validation activities for development labs.
- Review and approve technical documentation in accordance with FDA QSR (21 CFR Part 820) and ISO 13485 standards.
- Maintain the Design History File (DHF) to ensure integrity, completeness, and regulatory readiness for audits.
- Lead Risk Management activities, including FMECA, Hazard Analysis, and the creation of Risk Management Plans and Reports.
- Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues and technical challenges.
- Ensure compliance with GSPR (General Safety and Performance Requirements) and applicable international standards.
Required Qualifications
- Bachelor’s Degree in Engineering or a related technical field; a Master’s Degree is highly preferred.
- At least 5 years of experience in quality engineering, specifically within the medical device industry.
- In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 risk management standards.
- Proven experience with Design Control processes and the management of Design History Files.
- Strong analytical skills with proficiency in statistical data analysis and technical report writing.
- Excellent interpersonal skills with the ability to communicate effectively across all levels of the organization.
- Demonstrated initiative, ownership, and the ability to meet strict deadlines in a fast-paced environment.
Preferred Qualifications
- Previous experience with implantable medical devices and associated regulatory requirements.
- Working knowledge of EU MDR, EN 45502-1, and ISO 14708 standards.
- Advanced computer skills, including experience with specialized quality management software.
This role is situated in the vibrant tech and engineering hub of Plano, Texas. As a contract Design Quality Engineer, you will be integrated into a team where innovation meets rigorous compliance. Your expertise in FDA regulations and ISO standards will be vital in maintaining the company’s reputation for excellence in the healthcare sector.
Special Requirements
Contract position; Medical Device domain restriction; FDA/ISO compliance knowledge required; Onsite in Plano, TX.
Compensation & Location
Salary: $115,000 – $155,000 per year (Estimated)
Location: Plano, TX
Recruiter / Company – Contact Information
Recruiter / Employer: GAC Solutions
Email: praveena@gacsol.com
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