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Sr Manager- Operations Quality

Location: 

Kiryat Gat, IL

Job ID:  52261
Category:  Manufacturing & Operations

Stratasys is a world leader in 3D printing!

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

 

 

This position is responsible to develop, implement, and continuously improve product quality assurance and control systems and activities for Stratasys systems and materials. 

In this role:

Quality Assurance

  • Defines, specifies and drives the implementation of standards, methods and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products and materials sufficient to support end use manufacturing customer requirements
  • Ensure compliance with internal policies, procedures, applicable regulatory and statutory requirements and customer requirements in a mixed environment with products and medical devices (e.g. ISO 9001, ISO 13485, 21 CFR820)
  • Participate in product improvement and implementation strategies from marketing inception to product obsolescence.
  • Responsible for vendor qualification and incoming material quality
  • Define and administer internal and external quality oversight and audit functions
  • Teams with product support areas in gathering and analyzing customer data
  • Set quality objective KPIs, goals and reporting cadences for quality management, including Management Review, utilizing a risk-based approach in line with Corporate standards
  • Monitor performance to goals and expectations escalating as needed to support success
  • Present performance status to Executive team

Continuous Improvement

  • Drive an environment and culture of continuous improvement through utilization of CI tools and practices, statistics and data analytics
  • Partner and participates in the reviewing of engineering designs to contribute quality requirements and considerations to monitor process equipment calibration
  • Lead the Product Quality Team with driving Root Cause Analysis and Corrective Action and preventative action activities between operations, engineering, and supply chain for products and processes.

Management of Quality Team

  • Oversee, develop, and motivate a team of operations Quality professionals to maximize job efficiency and communication to reach team goals
  • Manage department staffing, including hiring, promotions, wage adjustments, etc.
  • Provide work direction to the organization, communicate company expectation metrics and Key performance indicators (KPIs), and manage performance and improvement activities.
  • Develop department budget and manage costs.
  • Ensures a robust integration and change management process is in place to lead the team
  • Stay current on all new and evolving standards for the industry and from Corporate Quality

 

Must have for this role:

  • Bachelor's degree in industrial engineering or related discipline
  • Master’s Degree in related discipline preferred.
  • Must be ITAR qualified.
  • 15+ years of experience in a complex high technology hardware and software-based end use product manufacturing environment to include a minimum of 8 years in quality management.
  • 6+ years management responsibility leading a team
  • Strong knowledge of ISO 9001:2015, ISO 13485:2016 applied to regulator cleared medical devices
  • Intermediate knowledge and experience with Six-Sigma and Lean Manufacturing concepts.
  • Intermediate skills in Microsoft Office suite applications and tools.
  • Travel Requirements- 10% of time

 

Preferred Qualifications

  • 3+ years of Quality Engineering and Process validation (IQ/OQ/PQ)
  • Product and process quality improvement experience via PPAP (Production Part Approval Process), Design and Process Failure Mode Effects Analysis (DFMEA, PFMEA), Measurement System Analysis (MSA), Control Plans, Statistical Process Control (SPC), etc.
  • Experience with root cause investigations and CAPA, statistics and data analytics.
  • Cross-industry experience in both regulated and non-regulated environments
  • Manufacturing experience in an extrusion environment
  • Additive manufacturing experience
  • Has experience with leading transformational change.
  • Six-Sigma Black Belt or Master Black Belt
  • Knowledge of Industry 4.0 technologies to advance quality performance.

 

What​ ​you​ ​will​ ​be​ ​part​ ​of:

 

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