28 days old

Quality Engineering Manager

Stryker
Cary, Illinois 60013
  • Job Code
    R427498
  • Job Type
    Employee
  • Job Status
    Full Time

Who we want
Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures

 

What you will do

  • Oversight of the Quality System including:
    • CAPAs
    • Nonconformances
    • Deviations
  • Oversight of all aspects of projects assigned to quality engineering department including but not limited to establishment of clear objectives, planning and scheduling, data trending and analysis, cost assessment, training, implementation, reporting, etc.
  • Effective closure of quality investigations including CAPAs by mentoring and coaching investigation owners to ensure comprehension, development and execution of corrective/preventive action with regards to cited nonconformity
  • Identify and communicate to quality leadership issues that impact product purity, quality, safety or efficacy, regulatory compliance or business continuity
  • Identify and continually improve process effectiveness
  • Ensure key site representation at external regulatory body audits
  • Provide SME input into quality planning process and assessment of risk
  • Monitoring of KPIs and process measures for the assigned area of management
  • Development of resources planning estimates to manage project workload and productivity
  • Procurement and assignment of Quality Engineering resources and general administration of the Quality Engineering department
  • Facilitation of effective project meetings, change and conflict management
  • Leading cross functional project team(s) through variety of project types
  • Creating and fostering strong working relationship across the organization to facilitate effective collaboration
  • Training, coaching and career development of Quality Engineers
  • Education and in-depth technical training on QE concepts, practices, and procedures.  Transfer of ideas and knowledge to wide variety of audience (regulatory inspectors, senior management, engineers, technicians, line operators, etc.)
  • Maintaining current knowledge of applicable domestic and international regulations

Requirements

What you need

Basic Qualifications:

  • Bachelor’s Degree in Engineering, Science, or related field
  • Minimum 5 years’ experience in working in a highly regulated environment, quality, manufacturing or engineering

 

Preferred Qualifications:

  • Managerial/supervisory strongly preferred
  • Six Sigma or Project Management Professional certification is a plus
  • Experience in quality management systems is essential
  • Knowledge of FDA regulation 21CFR820 required, knowledge of 21CFR 211 preferred
  • Knowledge of international standards and regulations as they pertain to Sage Products (i.e. MDD, ISO13485, EU GMPs, etc.)
  • Experience managing staff including administration and professional development
  • Proficiency in using problem solving methods, root cause analysis and use of statistical tools to resolve problems
  • Experience managing complex or high-level projects
  • Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality
  • Strong ability to facilitate discussions and negotiate mutually beneficial solutions when necessary
  • Demonstrated strong leadership skills
  • Excellent interpersonal, organizational and communication skills
  • Strong writing and editorial skills with attention to detail
  • Prior participation in regulatory inspections and audits
  • Strong computer skills in Word, Excel and Outlook

Categories

Posted: 2020-01-24 Expires: 2020-02-23

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Quality Engineering Manager

Stryker
Cary, Illinois 60013

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