We are looking for a Senior Quality Engineer to join our Quality team, based in St. Paul, MN. Reporting to the Director of Quality, the Senior Quality Engineer will work with both internal and external resources. This position is responsible for providing quality assurance support for the company’s ISO 9001 and 13485 quality management system and the products we design and manufacture in support of life sciences customers. This position will provide support to design engineering, purchasing, manufacturing and our customers.
Essential Job Responsibilities:
- Plans and conducts risk assessments and the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.
- Plans, conducts and documents product validation testing.
- Performs quality engineering reviews of design documentation for compliance with stated requirements including company quality records.
- Effectively interfaces with customers during early stages of product development and during product support activities.
- Applies lean problem solving tools to drive root cause analysis during quality assurance activities.
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
- Incorporates approved customer issues/requirements into Company 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 in an engineering or technical discipline
- Minimum of five (5) or more years of direct experience working as a quality professional
- Minimum of three (3) years of direct experience working in a manufacturing environment
Preferred Job Qualifications:
- Experience working in medical, bio processing or biopharmaceutical industries
- Knowledge of Quality Assurance within the Life Sciences field (Medical/Bio/Pharm) ISO 9001 and 13485
- Expertise in risk assessment and process validation.
- ISO 13485 certified environment experience.
- Certified Quality Engineer through ASQ (CQE, CRE, etc.).
- Knowledge of IQ/OQ/PQ for manufacturing and injection molding processes, specifically related to Life Sciences markets
- 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.