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Quality Engineer

Date: Feb 10, 2021

Location: Roseville, MN, US

Company: Dover Corporation

We are looking for a Quality Engineer to join our NPI Quality team, based in Roseville, MN.  Reporting to the Quality Engineering Manager – NPI (New Product Introduction), the Quality Engineer will work with both internal/cross-functional and external resources on projects supporting our Injection Molding Re-tool initiatives. This position is responsible for providing quality assurance support in conformity with CPC’s ISO 9001 and 13485 quality management system procedures, working in a team environment with Tooling, Continuation and Manufacturing Engineering on re-tool projects.

Position title and compensation are commensurate with experience.

Essential Job Responsibilities:

  • Actively participates as a cross-functional team member on multiple IM tooling projects.
  • Plans and conducts/facilitates risk assessments relating to IM tooling projects.
  • Leads component validation efforts associated with new or refurbished IM tools.
  • Plans & prepares component process validation plans & reports.
  • Applies appropriate statistical methods to evaluate validation and process data.
  • Works with molded component suppliers to ensure proper execution of process validation plans.
  • Partners with suppliers and CPC Supplier Quality to ensure production control plans are established to provide high confidence that molded components consistently meet requirements.
  • Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
  • Incorporates customer issues/requirements into processes and systems.
  • Communicates significant issues or developments identified during quality assurance activities and provides assistance towards recommended process improvements.
  • Prepares reports to communicate involvement and results of quality assurance activities and continuous improvement efforts.

Essential Supervisory Responsibilities:   

  • None

Required Job Qualifications:

  • Minimum Bachelor’s Degree in an engineering or technical discipline.
  • Minimum of three (3) or more years of direct experience working as a quality professional.
  • Working knowledge of ISO 9001, 13485 and 14971 and application within the Life Sciences (Medical/Bio/Pharm).
  • Expertise in risk management and process validation.

 

 

Preferred Job Qualifications:

  • Experience working in medical or biopharmaceutical industries.
  • Knowledge of Quality Assurance within the Life Sciences field (Medical/Bio/Pharm) ISO 9001 and 13485
  • Expertise in risk assessment, component qualification and process validation (IQ/OQ/PQ).
  • Certified Quality Engineer through ASQ.
  • Knowledge of injection molding, specifically related to Life Sciences markets.

Travel:           

  • Up to 10%

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.  Colder Products Company 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 Roseville, MN with global offices and operations in Europe and Asia.


Nearest Major Market: Minneapolis

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