Are you looking for an opportunity to grow where your experience matters? Do you strive for a career with meaning and purpose? If you thrive in a fast-paced environment and want to work with a great team, we might be a fit!

MGC Diagnostics (www.MGCDiagnostics.com) is a leader in providing innovative technology for cardio-respiratory diagnostics. We recognize that our success depends upon the capabilities of our employees to assist MGC Diagnostics in achieving its business goals. MGC Diagnostics is proud of its collaborative environment where it values contributions of each of its team members. We offer competitive benefits and profit sharing.

Position Title: Manufacturing Quality Engineer

Department: Quality Assurance/ Regulatory Affairs

Location: St. Paul, MN (on-site)

1. PRIMARY PURPOSE

The Manufacturing Quality Engineer ensures the highest standards of quality and compliance. The position is vital in overseeing the manufacturing processes to guarantee that all products meet regulatory requirements and company standards. This position will collaborate closely with production teams and quality assurance personnel to develop, implement, and refine manufacturing quality control systems.

1. ORGANIZATIONAL RELATIONSHIPS

Reports to: Manager, Quality Systems

1. KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS

Non-Conformance Report (NCR) and Investigation

Document and analyze NCR reports from Receiving/ Inspection and Production Departments

Perform containment and investigation actions related to non-conforming material/ products that escape production.

Prepare and communicate data analysis reports for monthly Product Performance and Quality Management Review meetings.

Production Analysis of Data

Analyze in-process and final checkout yield data.

Develop and provide reports and recommendations for monthly Product Performance and Quality Management Review meetings.

CAPA

Ownership and execution of production and vendor related Corrective Actions/ SCARs

Identify and recommend preventative actions, including continuous product and process improvement.

Risk Management

Collaborate with Risk Management Team to develop and maintain PFMEAs.

Design Assurance

Review and consult with Project Teams during the development process to ensure Company Design and Development procedures are followed through documentation audits and design reviews.

Audit

Support the execution of quarterly UL Audit and Annual Surveillance/ Recertification assessments by Notified Body.

Assist QARA team with auditing of suppliers.

Accept other responsibilities as assigned.

Complete training as identified by standard operating procedures and procedural work instructions.

Regular attendance is an essential job function.

Follow all Company policies and procedures relating to confidential propriety information (CPI), including what is outlined in the Confidentiality and Non-Solicitation Agreement.

CONTACTS

• All Departments
• Vendors, Contractors, Consultants, Notified Body, Distributors

JOB SPECIFICATIONS

Must have – Minimum Requirements

• Bachelor's Degree in Technical, Scientific, or Engineering discipline
• 5 - 7 years of experience in Quality Engineering, Design Assurance, or other Quality Systems role.
• Experience in Medical Devices or other regulated industry preferred
• Knowledge of ISO 13485, ISO 14971, IEC 60601, and other Medical Device related standards.
• Process orientated problem solver and strong documentation creation/ management experience.

Nice to have

• Audit experience (both as auditee and auditor)
• Lean/Six Sigma certification

WORKING CONDITIONS

Will be required to regularly sit for extended periods of time; use hands and fingers, handle or feel objects, talk, hear and see. Occasionally lift and/or move up to 25 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. The environment is fast-paced; time pressured and requires accuracy. Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate. The normal environment is quiet and typical of an open office setting with some areas that may be louder at times; along with time spent on the production floor, where environment can be louder due to equipment running.