We are looking for a Quality Engineer to join our Quality team, based in St. Paul, MN. Reporting to the Quality Engineering Manager – NPI (New Product Introduction), the Quality Engineer will work with both internal and external resources focusing on executing the quality deliverables associated with the Mold Retooling initiative. This long-term initiative is targeted at replacing or refurbishing a majority of CPC injection molded tooling. This initiative will increase the quality, capacity and our ability to deliver high quality products to all our customers. This initiative will meet the full requirements of CPS’s ISO 9001 and 13485 quality management system.
Essential Job Responsibilities:
Actively participates as a cross-functional team members relating to tooling projects.
Leads the component qualification deliverables associated with new or refurbished mold tools.
Plans and conducts/facilitates risk assessments relating to tooling projects.
Works with molding suppliers to ensure robust process validation execution.
Partners with suppliers to ensure control plans are in place and together with CPC supplier quality and receiving inspection to provide high confidence that molded components meet all expectations.
Applies appropriate statistical methods to evaluate validation and process data.
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.
Essential Supervisory Responsibilities:
Required Job Qualifications:
Minimum Bachelor’s Degree. engineering or technical discipline
Direct experience working as a quality professional
Direct experience working with injection molded products
Knowledge of basic statistical techniques (e.g. process capability, SPC, hypothesis testing, etc.)
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 (CQE, CRE, etc.)
Knowledge of injection molded tooling, processes and controls
Up to 15%
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.
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 St. Paul with global offices and operations in Europe and Asia.