Katalyst CRO · 14 hours ago
Sr. Design Quality Engineer
Plano, TX
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is focused on ensuring product quality and compliance in the medical device industry. The Sr. Design Quality Engineer will collaborate with cross-functional teams to uphold quality standards, protect safety, and support business objectives while adhering to regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Serve on product development teams to promote and assure quality in product development projects
Execute and support on-time completion of Design Control deliverables for Design Change, Clinical, and New Product Development projects
Work with cross-functional teams to execute and support Design Control processes, including Design Inputs, Design Outputs, Design Verification, and Design Validation
Support the assessment and establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support product development equipment qualification activities and inspection method development and validation activities
Review and approve design, development, and verification/validation deliverables in compliance with FDA QSR requirements and applicable ISO standards for implantable medical devices
Be accountable for Applicable Standards Documents and checklists, Labeling Verification planning and execution, Essential Output reports, and General Safety and Performance Requirements (GSPR)
Ensure Design History File (DHF) content completion, integrity, and compliance with regulatory and standards requirements; collaboratively communicate and resolve gaps
Lead Risk Management activities for development projects and supplier change requests, including creation and maintenance of risk assessments, risk management plans/reports, 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 systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors at all levels
Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
Qualification
Required
Bachelor's Degree in Engineering, a technical field, or an equivalent combination of education and work experience
5+ years of quality engineering experience with demonstrated use of quality tools and methodologies
Excellent verbal, written, and interpersonal communication skills with the ability to communicate effectively at multiple organizational levels
Strong analytical, problem-solving, critical thinking, and presentation skills
Demonstrated initiative, ownership, and accountability with the ability to plan, prioritize, and meet deadlines
Advanced computer skills, including statistical and data analysis and report writing
Preferred
Master's Degree in Engineering or a 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, and related standards
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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