Ztek Consulting · 1 day ago
Design Control Quality Engineer
Plano, TX
Contract
Onsite
Senior Level
$50/hr - $55/hr
5+ years expZtek Consulting is seeking a Sr. Design Quality Engineer who will assure that new or modified products conform to quality standards and establish compliance with the quality system. The role involves maintaining collaborative partnerships with cross-functional teams to protect patient/user safety while meeting business needs.
ConsultingHuman ResourcesInformation TechnologyLegalStaffing Agency
Hiring Manager
Aziz Quadri
Responsibilities
Serve on product development teams promoting and assuring quality in product development projects
Execute and support on-time completion of Design Control Deliverables for projects related to Design Change, Clinical and New Product Development
Work with cross functional team to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation
Support the assessment/establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support product development equipment qualification activities, inspection method development and validation activities
Review and approve design, development and verification/validation deliverables in compliance with FDA QSR requirements and ISO standards applicable to implantable medical devices
Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR)
Ensure Design History File content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Lead Risk Management activities for development projects and supplier change requests, including generation and maintenance of risk assessments, risk management plan/report, hazard analysis and failure mode effects & criticality analysis (FMECA)
Maintain Risk Management Deliverables to ensure continued acceptability of products based on post market feedback
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Qualification
Required
Bachelor's Degree in Engineering, Technical field OR an equivalent combination of education and work experience
5+ years of previous quality engineering experience and demonstrated use of quality tools/methodologies
Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Strong analytical/problem solving, critical thinking, and presentation skills
Demonstrates initiative, ownership and accountability; plans, prioritizes and meets deadlines
Advanced computer skills, including statistical/data analysis and report writing skills
Preferred
Master's Degree in Engineering or Technical Field
Previous Medical Device design and development experience
Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, etc
Company
Ztek Consulting
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for its clients.
201-500 employees
H1B Sponsorship
Ztek Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (1)
Funding
Current Stage
Growth StageLeadership Team
S
Shefali Sharma
Founder
Company data provided by crunchbase