Overview
Senior Quality Engineer Jobs in Minnesota, United States at Staftonic LLC
Title: Senior Quality Engineer
Company: Staftonic LLC
Location: Minnesota, United States
Senior Quality Engineer
Location: Minnesota, United States
Long-Term Project
Key Responsibilities
- Provide quality engineering support for New Product Introduction (NPI) projects.
- Develop and implement control plans, inspection plans, and quality requirements.
- Lead and facilitate PFMEA (Process Failure Mode and Effects Analysis) activities.
- Investigate and resolve non-conformance issues using root cause analysis and CAPA.
- Support validation activities including IQ, OQ, and PQ for processes, equipment, and systems.
- Analyze process data and prepare validation protocols, reports, and technical documentation.
- Collaborate with cross-functional teams including Engineering, Manufacturing, and Quality Assurance.
- Ensure compliance with QMS, ISO 13485, FDA, and other regulatory standards.
- Drive continuous improvement initiatives using Lean, Six Sigma, and statistical tools.
- Provide technical guidance on inspection methods, metrology, and measurement systems.
Required Qualifications
- Bachelor’s degree in mechanical, industrial, or related engineering discipline.
- 6+ years of experience in manufacturing or machining environments.
- Strong knowledge of Quality Management Systems (QMS) and regulatory requirements.
- Proficiency in GD&T and blueprint reading.
- Experience with process validation (IQ/OQ/PQ).
- Strong statistical knowledge, including DOE, Cp/Cpk, and SPC.
- Experience with statistical tools such as Minitab.
- Strong analytical, problem-solving, and communication skills.
Preferred Qualifications
- Experience in medical device manufacturing (highly preferred).
- Familiarity with ISO 13485, FDA CFR 21 Part 820, and EU MDR.
- Experience with advanced quality tools and continuous improvement methodologies.
- Active participation in professional organizations (e.g., ASQ).
Work Environment
- Work will be performed in both office and manufacturing environments.
- Exposure to manufacturing conditions including cutting oils, solvents, and chemicals.
- Use of personal protective equipment (PPE) may be required.
- Ability to sit, stand, and work with equipment for extended periods.
