Senior Quality Systems Manager

1 week ago


Minneapolis, Minnesota, United States ProMed Molded Products Full time
Job Title: Senior Quality Systems Manager

ProMed Molded Products is seeking an experienced Senior Quality Systems Manager to lead our quality management efforts. This role will play a key part in driving our growth strategy and establishing ourselves as a top-tier quality system provider.

Key Responsibilities:

  • Develop and implement quality management systems (QMS) aligning with ISO 13485 and FDA regulations.
  • Lead the development and deployment of QMS activities supporting company quality objectives.
  • Oversee supplier qualification, audit programs, document control, and investigation processes.
  • Collaborate with project development teams to identify technical and compliance requirements.
  • Assist with supplier audits, regulatory, and customer audits.

Tech Requirements:

  • Experience with HPLC, UV/Vis, FTIR, and KF instrumentation for lab testing.
  • Familiarity with current testing technologies for FDA-regulated products.
  • Knowledge of lean and six sigma methodologies.

Salary: $90,000 - $120,000 per year



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