Minor Hotels Europe and Americas

Senior Design Quality Engineer

Minor Hotels Europe and Americas

full-time

Posted on:

Location Type: Office

Location: Plano • Texas • United States

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Salary

💰 $62,200 - $150,250 per year

Job Level

Senior

About the role

  • 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

Requirements

  • 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
  • Nice to Have: 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.
Benefits
  • Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade
  • Company paid holidays
  • Personal Days
  • Sick Leave
  • Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
  • Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
  • Life and disability insurance
  • Employee assistance programs
  • Other benefits as provided by local policy and eligibility
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality engineeringdesign control processesdesign verificationdesign validationrisk managementstatistical analysisdata analysisreport writinginspection method developmentequipment qualification
Soft Skills
communicationproblem solvinganalytical skillscritical thinkingpresentation skillsinitiativeownershipaccountabilitycollaborationinterpersonal skills
Certifications
Bachelor’s degree in engineeringMaster’s degree in engineeringISO 13485 certificationISO 14971 certification