This Contract Position is with one of our Direct Clients. Please reach out to Kumar - knavneet (at)divihn(dot)com or Simoneta - spereira(at)Divihn(dot)com for more details about this position. You can also call Kumar - 630 847 1019 or Simoneta - 630 847 0953.
Job Title: Quality Engineer
Location: St. Paul, MN
Duration: 8 months
(Main purpose of the job) Provide Quality Engineering support to manufacturing and new product development teams through Engineering Investigations, Qualifications and Validations. Identify quality issues, participate in quality improvement projects and quality activities that impact manufacturing. Other related activities include: maintenance of on-going stability validations, non-conforming material investigations, maintenance of risk management documentation, and corrective and preventive actions when required.
Essential Duties and Responsibilities
(List of primary responsibilities of this role that account for 5% or more of the work. Incumbent may perform other duties as assigned.) 1. Responsible for preparation of written Engineering Investigation, Qualification and Validation plans, statistical analysis of data and preparation of reports to support manufacturing improvements, on-going validations, and new product development efforts.
2. Support product development teams to develop new products and transfer to manufacturing through participation/leadership of risk management activities, performance of component qualifications, and execution of test protocols.
3. Responsible for coordinating stability (shelf-life) studies for new and existing products.
4. Responsible for coordination of validation activities performed by outside contract services to ensure adherence to SSI specifications and expectations.
5. Initiate documentation or documentation changes (DCRs, Deviations, etc.) for products and processes as required to reflect validation/qualification activities and results.
6. Investigate and disposition nonconforming material reports (NCR events).
7. Initiate, investigate, and implement corrective and preventive actions as assigned.
8. Perform internal quality system and supplier audits, as assigned.
9. Complaint investigations as assigned by Product Surveillance or Supervisor.
10. Other duties as assigned.
Excellent oral and written communication skills.
Strong problem solving, technical writing and organizational skills.
Must have the ability to read/interpret design prints.
Working knowledge of FDA GMP and ISO 13485 requirements.
Knowledge of statistics and quality tools such as SPC, Risk Analysis, Process Capability, DOE, TQM methods, and Lean/Six-Sigma.
Working knowledge of MS Word, Excel, and Project applications.
Display a solid technical understanding of engineering principles and procedures.
Preferred; Sterilization and Process Validation experience.
Preferred; ASQ Certification in Quality Engineering.
Preferred; Previous Quality System auditing experience.
Education and/or Experience BS in Engineering or related field of science.
1 - 3 years of experience in Manufacturing Quality, Design Assurance or Quality Systems.
(The physical demands described 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 essential functions. If not applicable, then edit or remove.)
Long periods sitting or standing, using repetitive motions.
Bending and lifting up to 50lbs may be required on occasion.
Ability to travel, including occasional overnight trips.
Notes from Manager: Trackwise experience, test method validation, equipment and process validation experience would be desired for this position.
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.