Engineer - Quality - Sr.

US-UT-Salt Lake City
2 weeks ago(1/4/2018 8:14 AM)
Job ID
2018-28663
Category
Quality Assurance
Position Type
Contract (Full-Time)
# of Openings
1

Overview

Lead Quality Engineering activities for design, development, manufacturing and/or distribution of orthopedic implants and instruments to ensure a high level of process and product quality.

Responsibilities

  • Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business.
  • Ensure compliance to regulation and standards. Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
  • Work closely with operations and the business functions to ensure quality performance of product and processes. Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
  • Lead and participate in the development and improvement of the manufacturing processes for existing and new products. Analysis and review of concession requests.
  • Review and approval of change management activities. Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary. Support execution and analysis of QATs.
  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation. Proficient in risk management practices and tools, having high expertise in process risk.
  • Develop and provide input for risk management by identifying opportunities and weaknesses. Proficiency in and makes continuous strides towards optimization of inspection methods and sampling.
  • Support First Article Inspections. Proficiency in statistical methods and application. Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • Assist in the development, responsible for review & approval of process and equipment validation/qualification. Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
  • Coach and mentor others in quality topics and activities. 

Qualifications

  • Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality discipline.
  • Previous experience in a regulated environment desirable.
  • CQE or equivalent course work / experience desirable
  • Proficient in understanding of Med Device manufacturing processes desirable
  • Familiarity with ISO 13485, GDP, GMP desirable.
  • Lean Six Sigma training a distinct advantage.

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