Creation

Creation

Sr. Quality Engineer

Dallas, TX, USA · Senior

Sponsorship not specifiedDetected 30 days ago
AccessibilityExcelProcess ImprovementRecruitingGMPFDA RegulatoryLeadershipCommunicationProblem SolvingMentoringAdaptabilityMicrosoft Office

About the role

  • It's fun to work in a company where people truly BELIEVE in what they're doing!
  • We're committed to bringing passion and customer focus to the business.
  • The Senior Quality Engineer ensures day to day compliance with applicable quality and regulatory standards.

Responsibilities

  • Manage complaint/NCR database and address Customer issued SCARs
  • Supports NPI process for new products
  • Develops customer specific quality plans
  • Supports Site Quality Leader in regulatory, customer and internal audits
  • Leads and trains cross functional teams to perform layered process audits
  • Assist Site Quality leader to maintain and improve QMS
  • This position indirectly provides leadership to the Quality Engineering Support personnel within the site.
  • Supports and assists other Quality Engineers in the Customer Focused Team for systemic issues and CAPA resolution
  • Manages and collects systemic data for process improvement

Requirements

  • Minimum of 5 years' experience in a manufacturing environment as a quality engineer or equivalent
  • Demonstrated working knowledge of ISO 9001 and 13485 standards is required
  • Work experience in a cGMP FDA 21 CFR Part 820, AS9100, AS9102 and ISO 14001 environment is strongly desirable
  • Strong technical skills required including electronics and electro-mechanical principles
  • Experience in a PCBA low volume high mix or PCBA NPI desired
  • Knowledge of Statistical Process Controls (SPC), implementation and reporting
  • Familiarity with inspection practices and solder knowledge
  • Experience in the application of Lean and Six Sigma Methodologies - CSSGB or CSSBB desirable
  • Working knowledge and comprehension of quality management systems, measuring techniques, tools and equipment
  • Ability to lead problem solving activities with site level teams executing effective corrective actions
  • A Degree in Engineering or related technical discipline, and/or a combination of education and experience is required
  • ASQ CMQ/OE, CQE or CQA certification highly desirable

Skills

  • Highly proficient in MS Office Word and PowerPoint with advanced knowledge in Excel
  • Ability to make judgement calls on material conformance
  • Familiarity with IQ/OQ/PQ
  • Excellent communication and interpersonal skills adaptable to all levels of the organization
  • Seasoned at providing coaching, feedback and assisting in conflict resolution
  • Strong organizational and problem-solving skills
  • Entrepreneurial, creative and high-energy team player with the proven ability to balance competing priorities
  • Must be detail oriented, organized, and have ability to inspire others towards a quality minded culture
  • Must be capable of working independently to achieve project schedules and goals
  • Driven by a high degree of integrity, with cultural and core value alignment to Creation
  • Strong learning mindset
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This listing is sourced directly from Creation's careers page and normalized into a canonical job model.