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Supplier Quality Engineer - Bio

Date: Sep 2, 2021

Location: Roseville, MN, US

Company: Dover Corporation

SUPPLIER QUALITY ENGINEER

 

Job Summary:

The Supplier Quality Engineering role will have direct responsibilities to support CPC’s growth in the biopharmaceuticals market. This position will have responsibilities for qualifying suppliers, driving improvements in supplier performance, conducting supplier audits, and providing component and product inspection verification to the Quality department in Receiving Inspection. This position must also ensure that these activities are accomplished in compliance with applicable industry/regulatory standards and company quality objectives.

Essential Job Responsibilities:

  • Lead / participate in supplier audits as required and update / maintain the Approved Supplier List and Audit Schedule.
  • Provide process verification of inspection procedures, resolve measurement discrepancies, and improve correlation in measurement method between suppliers and Receiving Inspection.
  • Collaborate with Bio suppliers and applicable CPC functional teams in developing highly capable, repeatable, and reproducible test methods.
  • Interface with Bio suppliers to drive corrective/preventive actions through SCAR and/or CAPA process based on risk-based decisions from quality signals in Receiving Inspection and manufacturing floor to prevent reoccurrence.
  • Provide Supplier Quality Engineering support to Sourcing team in support of supplier performance management and agreement negotiations.
  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Participate in supplier selection process and specification reviews with Bio suppliers.
  • Collaborate cross functionally to specify quality characteristics and inspection plans for components.
  • Collaborate with Tooling, Design, Manufacturing, Product Management, and Supply Chain in planning and executing new or refurbished tools.
  • Participate in continuous improvement collaboration, execution, and training.
  • Collaborate with Sourcing on Supplier risk management to execute Bio Supplier strategic initiatives.

    Basic Job Qualification:
  • Four year engineering degree with a minimum of 5 years of Quality industry experience, or
  • Technical Degree with a minimum of 10 years of Quality industry experience
  • Exposure to ISO: 9001 2015 and 13485 2016
  • Experience working with data and statistical analysis software
  • Strong communication skills
  • Experience with problem solving tools
     
    Preferred Job Qualification:
  • Working experience with ISO: 14644 and 14698
  • Certified Quality Engineer
  • Auditing experience
  • Experience working with Suppliers
  • Experience with mold and/or machining processes
    Travel:           
  • Up to 15%
     
     
     
    Physical Demands:
  • The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
     
    The employee must frequently lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand, walk and/or stoop.
     

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    • The noise level in the work environment is usually moderate.
       
      This job description is not designed to contain a comprehensive list of tasks, responsibilities or duties.  CPC reserves the right to amend to meet legal, business and organizational requirements as necessary.
       
      About CPC (Colder Products Company)
      We are Colder Products Company, the industry leader in the design and manufacture of specialized quick disconnect couplings for the life sciences, industrial, and chemical handling markets.   Used around the world in a broad range of applications, connection technologies from Colder Products Company allow flexible tubing to be quickly and safely connected and disconnected, reducing spills and increasing safety.  Colder Products Company, a Dover company, is based in St. Paul with global offices and operations in Europe and Asia.


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