Quality Engineer

3M•Us, SD

1d•Onsite

About The Position

The Quality Engineer assures compliance with internal procedures, external customer requirements, and regulations. The role represents the customer by evaluating complaints, issues, samples, and trends and determining appropriate action plans. It leads CAPA, Risk Management, Quality at the Source, and Customer Quality Index initiatives and deployment; supports Statistical Process Control (SPC) deployment; and uses statistical techniques to create sampling plans and analyze data. The engineer develops new test methods and validates test methods for new and existing products, participates in internal and external quality system and process audits, provides quality oversight for change management and associated training or qualifications, and supports the process engineering team. The position is based on-site in Aberdeen, South Dakota, and may involve up to 10% domestic travel. Relocation assistance may be authorized.

Requirements

Bachelor's degree or higher in a science, engineering, math, or technical discipline from an accredited institution, completed and verified before starting.
At least two years of experience in an engineering, quality, or other technical role in a private, public, government, or military environment.
Must be legally authorized to work in the country of employment without sponsorship for employment visa status.

Nice To Haves

Statistical knowledge and Lean Six Sigma familiarity.
Audit experience with ISO 13485, IATF-16949, AS9100, or ISO 9001.
Previous quality experience in a medical device or drug manufacturing environment.
Experience deploying industry-specific quality system requirements beyond ISO 9001, such as NIOSH, CSA, or ANSI.
Test method development and validation experience.

Responsibilities

Assure compliance with internal procedures, external customer requirements, and regulations.
Represent the customer by evaluating customer complaints and issues, samples, and trends, and determining necessary action plans.
Lead Corrective Action Prevention Action (CAPA), Risk Management, Quality at the Source, and Customer Quality Index initiatives and deployment.
Assist with deployment of Statistical Process Control (SPC) methodology to control Key Process Indicators (KPI).
Use statistical techniques to create sampling plans and execute data analysis.
Develop new test methods and execute test method validations for new and existing products.
Participate in internal and external quality system and process audits.
Provide change management oversight from the quality function to ensure adequate training and/or qualification for changes to assigned products and processes.
Provide support to the process engineering team.
Comply with corporate policies, procedures, and security standards while performing assigned duties.
Contribute to a strong Environmental Health and Safety (EHS) culture by following safety policies, identifying hazards, and engaging in continuous improvement.