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Manager, Supplier Quality & Regulatory Excellence

Location: 

Eden Prairie, MN, US

Job ID:  39583
Category:  Manufacturing & Operations

 

This position is responsible to own and develop the global supplier quality & regulatory compliance excellence framework, including but not limited to the process, governance, performance, risk management, supplier development, qualifications, outsourcing and continuous improvement to support end use manufacturing.  Additionally, this role will be responsible to execute and manage Supplier Quality & Regulatory Assurance activities for third party materials and emergent business units as needed.
 

 

  1. Essential Responsibilities:    List the major position tasks with responsibilities in order of priority.  Also include the approximate percentage of time spent on each component.

 

 

% of Time

 

1.

Supplier Quality & Regulatory Excellence Framework

  • Assess current Supplier Quality & Regulatory compliance management framework vs. benchmarks for end use manufacturing and develop future state strategy and plan.
  • Own governance of the global supplier quality and regulatory management program to ensure compliance to quality and regulatory standards.
  • Establish and execute an internal and Supplier Development Plan based on the future state framework.
  • Based on the future state needs and growth trajectory of Stratasys, determine resource levels to fulfill supplier quality & regulatory assurance activities and develop an Outsourcing Development Plan.

     

20%

 

 

 

2.

 Supplier Quality Assurance & Development

  • Execute and manage Supplier Quality & Regulatory Assurance activities for third party materials and emergent business units as needed.
  • Establish robust Quality Plans with suppliers as needed and conduct audits and assessments of suppliers to validate requirements are being met.
  • Execute Supplier development plan activities coordinating with suppliers and internal functions.

 

40%

 

 

 

 

3.

Performance Management/KPIs

  • Establish process and standard work for Global Supplier Quality Performance/KPIs and Risk management and associated management reviews
  • Ensure Supplier Quality Performance KPIs and reporting are implemented consistently and to minimum requirements
  • Develop metric for Cost of Poor Supplier Quality and ensure reporting in place for all product lines
  • Present global Supplier Quality & Regulatory reports to Executive leadership

 

20%

 

 

4.

Continuous Improvement

  • Drive an environment and culture of continuous improvement for Supplier Quality
  • Measure and monitor effectiveness of Supplier CAPA processes
  • Partner with internal businesses and functions to identify and establish a Supplier Quality & Regulatory Improvement Plan based on yearly Supplier Quality Performance results and monitor progress
  • Support Root Cause Analysis and corrective action/preventative action activities for significant product failures. 

10%

 

 

5.

Other

  • Follow all company applicable policies and procedures
  • Attend all required company training
  • Demonstrate commitments to Stratasys Behaviors by leading, acting, and modeling these values.
  • Other Responsibilities as assigned by the department or manager

 

     

10%

 

This description is intended to be only a general outline of major responsibilities.  It is expected that the employee performs these and any other activities which may be assigned or which may occur in the normal course of work.

 

III.        Supervision:                                   

           

 

Does this position supervise other employees?

                     No                    Yes

 

 

 

 

 

 

 

What are the supervisory responsibilities?

(Check all that apply)

  Accountable for hiring & discharging decisions

Initiate or recommend salary action

  Accountable for the work performance of the team

  Responsible for training

  Conduct performance appraisals and coach for career development

  Manage department budget

 

 

 

If no, does this position assign and/or check the work of others but without the above responsibilities?     No      Yes

 

Total direct and indirect supervised by this position:         _____ Direct reports                         Indirect reports

       

 

 

  1. Education Required:             List the minimum educational requirements or equivalent combination of education and experience required.

Include required certifications and/or professional credentials. Please indicate years of experience required, in lieu of education (if applicable).

 

         High School Diploma, or equivalent

         Associate’s Degree (two years) in      

         Four Year Degree – Industrial Technology, Engineering or related discipline

         Master’s Degree in related discipline preferred

  Doctoral degree in      

 

 

 

 

         Other (include certifications and/or professional credentials): 

Certified Supplier Quality Auditor     

 

  Years of experience in lieu of education above (if applicable):

 

 

 

Basic Qualifications:    Indicate the years of experience and type of experience required to effectively perform the essential functions and responsibilities of this position.                          

 

 

  • Must be ITAR qualified Yes No
  • 8 years of experience in a complex high technology hardware and software-based product environment to include a minimum of 5 years in quality, operations and/or sourcing.
  • Proficient knowledge of Quality Management Systems and report analytics, and root cause analysis tools and methods
  • Intermediate skills in Microsoft Office suite applications and tools.
  • Ability to work within a complex environment with cross-functional teams across different geographies.

 

 

 

 

       

 

 

  1. Preferred Qualifications:      Indicate the years of experience and type of experience required to effectively perform the essential functions and responsibilities of this position.

 

  • Highly motivated and self-starter with a strong desire to succeed and pursue continued growth and developmental opportunities.
  • Expertise in Supplier Quality processes at product & process development & execution phase (PFMEA, Control Plan, problem solving methodologies, FAI, PPAP, …)
  • Experience with global product regulations for materials and hardware (e.g. Product Safety, Environmental)
  • Demonstrated experience at influencing and driving corrective action with large global suppliers
  • Six Sigma and Lean certification and/or experience
  • ASQ Certifications

 

 

 

  1. Travel Requirements:           Indicate travel requirements and location.

 

 

No Travel

 

Location of travel:

 

10% of time

 

International

 

25% of time

 

Regional

 

50% of time

 

Domestic

 

 

 

 

 

 

  1. Other Position Requirements:        List other job requirements (Behaviors)

 

Problem Solving: Identifies problems, develops and evaluates options, and implements solutions, with a focus on contiguous improvement

Drives Results:  Consistently achieving results, even under tough circumstances

Customer Orientation: Considers and meets internal and external clients’ or customers’ needs and expectations during product or service development, manufacturing, marketing, delivery, and/or support

Teamwork: Promotes and facilitates coordination and cooperation among peers

Technical/Functional Expertise:  Applies and improves extensive or in-depth specialized knowledge, skills, and judgment

Learning: Actively leaning through experimentation when tackling new problems, using both successes and failures as learning fodder.

Drives Vision and Purpose: Painting a compelling picture of the vision and strategy that motivated others into action

Negotiations: Achieves desired outcomes between multiple parties to settle disputes and reach agreements for the benefit of parties involved.

Process Design:  Designs practices, processes, procedures, and systems to manage work, simplify, and use resources efficiently

Results Orientated: Consistently achieving results, even under tough circumstances

Cultivates Innovation: Creating new and better ways for the organization to be successful

Communications:  Effectively transfers information and express ideas to individuals or groups in oral and written form

Develops Talent: Developing people to meet both their career goals and the organization's goals

Resources Allocation: Ensures effective, efficient, and sustainable use of the organization’s financial resources, inventory, human capital, material, and information technology

Risk Management: Identifies, reports, and mitigates risks to oneself, others, the environment, and the organization

Builds Effective Teams: Building strong-identity teams that apply their diverse skills and perspectives to achieve common goals

 


Nearest Major Market: Minneapolis