Senior Quality Assurance Specialist

6 days ago


Germantown, Wisconsin, United States MGS Mfg. Group, Inc Full time
Overview
MGS Mfg. Group, Inc., a leading provider of healthcare manufacturing solutions, seeks an experienced Quality Engineer to join their team.

MGS provides robust end-to-end solutions combined with strong customer focus and seamless collaboration, making them the engineering and manufacturing partner of choice for today's leading Pharma, Diagnostic, and MedTech innovators.

As a global organization with 12 strategically located facilities, MGS transforms their customers' most pressing challenges into innovations that improve lives.

The ideal candidate will possess three to five years of experience in problem-solving, statistical analysis, and GD&T. Additionally, they will have experience working with teams to achieve results and demonstrate strong communication skills.

Job Description
Key Responsibilities:
  • Maintain the Quality Management System (QMS) ensuring compliance to both internal MGS processes and requirements imposed by certification bodies, regulatory agencies, and specific customer requirements.
  • Address customer complaints and internal quality issues through the corrective action process, utilizing quality tools to ensure satisfactory resolution.
  • Develop and validate measurement systems, establishing validation plans/protocols and ensuring completion to meet all requirements.
  • Approve product for shipment by performing batch record reviews, generating Certificate of Analysis, and releasing product in the ERP system.
  • Support engineering change process, managing product inspection and testing activities, updating production documents, and submitting documents to customers for approval.

Requirements
Qualifications:
  • High School Diploma or equivalent required, BS degree in engineering or business preferred.
  • Three to five years of experience and/or training, or equivalent combination of education and experience.
  • Demonstrated experience in problem-solving and statistical analysis.
  • Gauge Design and Tolerancing (GD&T) experience.
  • Experience working with teams to achieve results.

Benefits
MGS Mfg. Group, Inc. offers a competitive benefits package including medical, dental, and vision insurance, company-paid life and disability insurance, paid time off, and a generous 401(k) match. For more information about MGS, visit www.mgsmfg.com.

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