Manufacturing/Quality Engineer
Mendell - Lakeville, MN

Manufacturing/Quality Engineer - 1st Shift

Job Status:
Full-time, exempt

Wage:
Dependent on experience and qualifications

This position requires a candidate with a strong manufacturing background and excellent continuous improvement record.

As a Mendell Manufacturing/Quality Engineer, you will work with some of Minnesota’s best and brightest manufacturing professionals in an ultra-clean facility equipped with cutting-edge technology.

Mendell offers competitive pay, a comprehensive benefits package including two weeks of paid time off accrual your first year, 401k with employer match, health, dental, life, and disability insurance.

Summary:
This position will assist with managing the Quality System to maintain compliance with ISO13485 and 21 CFR part 820 (Quality System Regulation), and provide focused, quality engineering support of the Quality System including the Complaint, CAPA, Risk Management, Supplier Quality and Document Control processes

Responsibilities:

  • Ensure Quality Management documentation and reporting are maintained
  • Identify and implement improvements to the documentation system
  • Support quality goals by coordinating corrective actions and continuous improvements
  • Coordinate the tracking and closure of Quality issue-related documentation and Change Control within the Corrective Action/Preventive Action & MRB System
  • Perform internal and external audits
  • Support customer and regulatory audits of ISO-13485:2003 registered QMS
  • Design, document and implement methods of process improvement and process control * Contribute to training and support for quality methods, statistical methods, test/inspection procedures, root cause analysis and problem solving
  • Monitor and maintain multiple quality improvement projects including: quality systems, process, product and field quality issues
  • Adhere to the Quality Management System and documented processes

Required Qualifications and Skills:

  • Attentive to detail, organized, and able to prioritize to meet deadlines
  • Works effectively both on independent basis and as part of a team
  • Maintains and promotes a personal and professional "continuous improvement" philosophy
  • Excellent, professional written and verbal communication skills; strong interpersonal skills
  • Excellent computer skills in Visio, Minitab, and Microsoft Office Software: Word, Excel, Outlook, PowerPoint
  • Excellent understanding of Enterprise Resource Planning (ERP) Software

Education and Experience:

  • Bachelor’s degree in a technical discipline, preferably in Quality Assurance or Mechanical Engineering field or equivalent combination of education and experience
  • Minimum of 3 years of experience in a Quality Assurance position in an FDA regulated (or similar) manufacturing environment
  • ISO-13485:2003 experience. ASQ certifications (CQE, CMQ/OE, CSSBB), strong statistics background, mechanical and or machining experience and GD&T knowledge preferred

THIS IS NOT AN ENTRY LEVEL POSITION

If qualified, please send resume and references

Principals only. Recruiters, please don't contact this job poster.
Do not contact us with unsolicited services or offers.


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About this company
Mendell is a medical manufacturer of world-class precision machined medical devices.