Sign upLog in
JobsJobs in TexasJobs in Plano, TXIT Jobs in Plano, TXIT Quality Assurance Jobs

Sr. Design Quality Engineer

Katalyst Healthcares & Life Sciences

Plano, TX

Apply
JOB DETAILS
SKILLS
Analysis Skills, Business Support, Change Control, Change Requests/Orders, Code of Federal Regulations, Communication Skills, Computer Skills, Corporate Policies, Cross-Functional, Customer/Client Research, Data Analysis, Design Verification, Engineering, Environmental Management Systems, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), Hazard Analysis, ISO (International Organization for Standardization), Implants, Interpersonal Skills, Maintain Compliance, Medical Equipment, Medical Products, Medical Protocols, Operations Processes, Patient Safety, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Product Support, Promotional Programs, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulatory Compliance, Regulatory Requirements, Reporting Skills, Risk Analysis, Risk Management, Statistics, Technical/Engineering Design, Time Management, Validation Testing, Writing Skills
LOCATION
Plano, TX
POSTED
30+ days ago
Job Summary:
  • The Sr. Design Quality Engineer is responsible for ensuring new or modified products conform to established quality standards and comply with the quality system.
  • This role partners closely with cross-functional teams to promote quality throughout product development, protect patient and user safety, and support business objectives while maintaining compliance with FDA and applicable regulatory and ISO standards.

Roles & 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.

Education & Experience:
  • 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.
  • Master's Degree in Engineering or a technical field (preferred).
  • Previous medical device design and development experience (preferred).
  • Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, and related standards (preferred).

About the Company

K

Katalyst Healthcares & Life Sciences

Resume Resources

Free Resume TemplatesFree Resume Builder