Supplier Quality Engineer III

You can make a difference

At KARL STORZ, we take pride in helping patients
through some of the toughest journeys of their lives.
We are making contributions that matter.
Regardless of your role, YOU improve patients’ lives every day.

Get to know us and join our team.

Job Function:
Supply Chain & Procurement

Location:

Charlton, MA, US, 01507

Work Location (for field-based positions):

Work Flexibility:
Onsite (Office/ Production)

Provide technical support for supply chain management. Works closely with Purchasing and KARL STORZ suppliers to develop and implement product requirements and associated process controls. Implements and uses statistical analysis techniques to monitor supplier performance, spearheading any required actions in a continual improvement environment. Assists in the activities to move to and sustain Lean Manufacturing.

• Technical lead in the identification, development, and qualification of suppliers.
• Technical lead in the maintenance and improvement activities associated with supplier certification and supply chain management.
• Works closely with critical suppliers to review and implement statistical analysis techniques to ensure supplier process stability and capability and to monitor the performance of the supplier.
• Works closely with procurement and manufacturing to implement lean techniques in the production, receipt, and consumption of supplied products within KARL STORZ operations.
• Technical lead in identifying, developing, and approving results of any required supplier validation and re-validation protocols on new or changed supplier processes/products.
• Performs system, product, and process audits of suppliers to assist in developing suppliers and assuring continual improvement.
• Assists in the identification of critical dimensions and features of supplied products.
• Analyzes trends in product/process performance from new product development through service, coordinating any required root cause analysis and corrective action associated with suppliers.
• Assists in the review and disposition of non-conforming material received from suppliers.
• Attend MRB meetings as required.
• Regular attendance is an essential job function.
• Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KARL STORZ products and services.
• Performs system, process, and product assessments within KARL STORZ, spearheading any required follow-on actions.
• Assists in sustaining manufacturing and service processes.
• Performs other related duties as assigned by supervisor.

Required

Minimum years of relevant work experience:

• Bachelor’s Degree in an Engineering, Math, or related discipline with 4-8 years of experience in manufacturing or Masters in an Engineering, Math, or related discipline with 3-6 years of experience in manufacturing.
• Maintaining an ASQ certification as a Quality Engineer, Six Sigma Green Belt, or Six Sigma Black Belt will be considered in place of a Bachelor’s degree.

• Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21
  
  CFR Part 820, ISO
  13485, ISO
  9001).
• Knowledgeable in GD&T and can explain clearly to Suppliers who don’t understand.
• Working knowledge of Lean Six Sigma principles and Supply Chain Management.
• Working knowledge of statistical analysis techniques such as, but not limited to: SPC, DOE, pFMEA, and Measurement System Analysis.

• Proficient in utilizing common “off the shelf” mechanical measuring and electronic test equipment.
• Able to read and comprehend engineering drawings and specification sheets.
• Demonstrated ability to successfully develop processes, define process controls, and validate process and product performance.
• Demonstrated ability to successfully manage multiple assignments and projects.
• Demonstrated ability to successfully lead teams in a consensus building effort towards a defined goal.
• Strong written, verbal, analytical, and interpersonal skills.
• Good interpersonal skills to communicate clearly with manufacturing, purchasing, engineering, and supplier personnel.
• Must possess strong…