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Quality Engineer
Solventum. Support marketed medical device and drug products by managing changes, handling complaints, conducting CAPA, leading risk management, performing design validation, developing and validating physical and analytical test methods, and ensuring compliance with the QMS and global medical device and drug product regulations .
Core Competencies
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Demonstrates expertise in managing changes and ensuring compliance with QMS and global regulations in the medical device and pharmaceutical industries. Proficient in applying statistical and quality engineering tools to support risk management and process improvement initiatives.
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About the role
Key responsibilities & impact- Support marketed medical device and drug products by managing changes, handling complaints, conducting CAPA, leading risk management, performing design validation, developing and validating physical and analytical test methods, and ensuring compliance with the QMS and global medical device and drug product regulations
- Review batch records for drug product release
- Investigate, escalate, and resolve nonconformances and deviations
- Collaborate with internal cross-functional team members and external suppliers to ensure performance
- Prepare for and participate in government inspections, customer audits, notified body audits, and internal audits
- Comply with corporate policies, procedures, and security standards
Requirements
What you’ll need- Bachelor’s Degree or higher
- Seven (7) years of experience in combined product, quality, engineering, and/or laboratory/technical experience
- Three (3) years of experience in the drug, pharmaceutical, and/or medical device industry
- Legally authorized to work in the country of employment without sponsorship for employment visa status
- Experience leading and collaborating on cross-functional projects
- Experience applying statistical and quality engineering tools, such as Gage R&R, ANOVA, FMEA, SPC, process capability analysis, regression analysis, and design of experiments (DOE)
- Experience working in an engineering, analytical chemistry, or other laboratory-based technical role
- Experience analyzing technical, quality, manufacturing, and/or product-related issues and supporting risk-based decisions
- Experience managing multiple priorities, projects, or initiatives and achieving established objectives
- Experience communicating technical information to stakeholders through verbal discussions, presentations, and written communications
- Experience leading process improvement initiatives
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
- Up to 20% domestic/international travel
- Relocation Assistance may be authorized