Quality Engineer

Solventum

Acera Quality Engineer ensuring compliance and quality standards for medical devices at Solventum. Collaborating with teams to optimize quality management systems and direct production documentation.

Posted 5/30/2026full-timeRemote • Montana • 🇺🇸 United StatesMid-LevelSenior💰 $90,000 - $110,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality management systemmanufacturing batch recordstest method validationsrisk assessmentsCAPA activitiesdocumentation controlcalibration recordspreventive maintenance trackingregulatory compliancequality standards training

Soft Skills

analytical skillsproblem-solving skillscommunication skillsorganizational skillsdetail-orientedindependent workcollaborative work

Certifications

Bachelor’s DegreeISO 13485 certification