Quality Engineer

3M•Us, SD

18h•Onsite

About The Position

This position provides an opportunity to transition from other private, public, government or military experience to a 3M career. As a Quality Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative people around the world. Here, you will make an impact by assuring compliance to internal procedures and external customer requirements and regulations, representing the customer, evaluating customer complaints and issues, samples and trends, and determining the necessary action plans. You will also lead Corrective Action Prevention Action (CAPA), Risk Management, Quality at the Source and Customer Quality Index initiatives and deployment, assist in the deployment of Statistical Process Control (SPC) methodology to control Key Process Indicators (KPI), and use statistical techniques to create sampling plans and execute data analysis. Additionally, you will develop new test methods and execute test method validations for new and existing products, participate in internal/external quality system and process audits, provide change management oversight from the quality function to ensure adequate training and/or qualification of changes to assigned products and processes, and provide support to the process engineering team.

Requirements

Bachelor's Degree or higher in a science, engineering, math, or technical discipline (completed and verified prior to start) from an accredited institution
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status)

Nice To Haves

Two (2) or more years of experience in engineering, quality, or other technical role
Statistical knowledge and Lean Six Sigma familiarity
ISO 13485 or ISO 9001 audit experience
Previous quality experience in a medical device or drug manufacturing environment
Experience deploying industry specific quality system requirements beyond ISO9001 (e.g. NIOSH, CSA, ANSI etc.)
Test method development and validation experience

Responsibilities

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