Solventum logo
Solventum

Enabling better, smarter, safer healthcare to improve lives.

Quality Engineer

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

Missouri

Posted

12 days ago

Salary

$90K - $110K / year

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Quality Engineer

Solventum

• Review, approve, and maintain manufacturing batch records and quality documentation for production, testing, sterilization, and validation activities. • Support and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA regulations, and medical device quality standards. • Manage documentation control, calibration records, preventive maintenance tracking, and records management processes. • Execute and support test method validations, risk assessments, CAPA activities, and continuous quality improvement initiatives. • Conduct and support internal and external audits, inspections, and corrective action follow-up to ensure regulatory compliance. • Provide QMS and quality standards training to employees, including development of training materials for new and existing staff. • Collaborate with cross-functional teams including manufacturing, R&D, regulatory affairs, and external stakeholders to resolve quality issues and communicate performance metrics.

Job Requirements

  • Bachelor’s Degree or higher from an accredited university
  • 3+ years of experience in quality engineering, quality assurance, or quality management within the medical device industry
  • Knowledge of ISO 13485, FDA regulations, and other applicable quality standards
  • Experience supporting or participating in internal and external audits
  • Strong analytical, problem-solving, communication, and organizational skills
  • Detail-oriented with the ability to work independently and collaboratively within a team environment

Benefits

  • Medical, Dental & Vision
  • Health Savings Accounts
  • Health Care & Dependent Care Flexible Spending Accounts
  • Disability Benefits
  • Life Insurance
  • Voluntary Benefits
  • Paid Absences
  • Retirement Benefits

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