Quality Champion

US-CA-San Diego
2 months ago
Job ID
2017-2720
# Positions
1
Experience (Years)
5
Category
Engineering
Company
Braemar Biotelemetry Technology

Overview

The Quality Champion is a leader and quality expert responsible for implementing process improvement projects with the objective of increasing levels of efficiencies and productivity.  This position is responsible for providing expert analysis on project and product quality and to provide input for product and process reengineering within our manufacturing and design operations. He/she will lead project team(s) to develop and implement quality process and improvement utilizing advanced analytical and problem solving techniques as well as work with senior management within the organization to coordinate activities as they relate to processes and operating models.

Responsibilities

  • Lead end-to-end product and process Quality improvement teams, as well as identifying and implementing prioritized Quality improvement opportunities using process excellence and related tools such as 6 Sigma and Lean techniques
  • Serve as subject matter expert in facilitating and leading root cause analysis for project teams utilizing appropriate investigational and problem solving techniques
  • Drive mindset/culture of a continuous improvement across quality, design and manufacturing
  • Develop and generate quality data reporting, analysis/trending, and audits for developing plans and programs to support continuous quality improvement
  • Drive implementation of corrective and preventive actions based on monitoring of quality data trends
  • Drive capture of best practices and undertake knowledge sharing sessions for wider implementations
  • Support leadership in the development of advanced and effective quality control processes and techniques
  • Develop, deploy, and manage all Continuous Improvement and Quality Assurance policies, programs, processes and procedures
  • Provide consultation and direction to ensure Quality System programs, processes and procedures are implemented successfully and function as designed to ensure the quality and integrity of products manufactured
  • Promote quality concepts and principles throughout the organization by providing guidance/training and leadership for the development and administration of a Total Quality Management System
  • Lead and direct the overall Continuous Improvement Process for facilities by providing training to the organization on the use and practice of Lean methodology and tools (5S, Kaizen, Design for Lean, 6 Sigma, etc.)
  • Plan and assist in the execution of various Lean events targeted toward improving the business performance in all areas of quality, delivery, and cost
  • Lead large scope global projects as assigned

Qualifications

  • Bachelor’s degree in Engineering or related scientific / technical field; or equivalent combination of education and experience
  • Six Sigma Green or Black Belt, ASQ certified Quality Auditor (CQA), Quality Engineer (CQE) preferred
  • Five (5)) or more years’ experience leading Quality improvement, process redesign, and LEAN initiatives preferred
  • Experience in a manufacturing environment utilizing process improvement methodologies such as TQM, ISO, Lean Manufacturing and/or Six Sigma preferred
  • Deep knowledge of data analysis and statistical techniques
  • Strong leadership and influencing skills that inspire team confidence and respect while motivating team members in a creative and effective manner
  • Proven technical leadership with the ability to utilize structured problem solving methods to deliver results
  • Successful track record in driving compliance and quality improvement in design and manufacturing
  • Proven experience leading large scope improvement projects
  • Deep knowledge of failure investigation principles
  • Excellent written and verbal communication skills
  • Strong attention to detail with excellent accuracy
  • Demonstrated competence to work and communicate effectively with all levels in the organization
  • Experience within a FDA medical device regulated industry and/or technical QA experience in a regulated industry such medical device manufacturing experience preferred
  • Strong knowledge of CAPA and other change management techniques preferred
  • Strong knowledge and understanding of FDA Quality System Regulation 21 CFR Part 820, ISO 14971 and ISO13485 regulation.
  • Proficiency with the Microsoft Office suite
  • Ability to travel domestically as appropriate to implement strategic initiatives, approximately 15-25%

BioTelemetry is an Equal Opportunity Employer

Company

Braemar Biotelemetry Technology

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