Supplier Engineer III – Medical Device

Pharmavise Corporation

. Remediate activities identified by CAPA 7720 for contract-manufactured sourced finished medical device products .

Posted 11/5/2026full-timeMaple Grove • Minnesota • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in supplier process validation, change management, and compliance within the medical device manufacturing sector. Strong problem-solving abilities and effective communication skills are essential for leading remediation activities and ensuring product quality.

Highest-signal resume keywords

Supplier Process ValidationChange ManagementManufacturing ExperienceValidation ExperienceStatistical Methods

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process Risk DocumentationInspection ValidationInstallation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Test Method Validation (TMV)CAPA RemediationQuality ComplianceStatistical AnalysisSix Sigma Methodologies

Soft Skills

Problem-Solving AbilitiesExcellent CommunicationProject Management SkillsSelf-DrivenResults Orientation

Industry Keywords

Medical DeviceManufacturing EnvironmentSupply Chain ManagementQuality PolicyPatient Safety

About the role

Key responsibilities & impact

Remediate activities identified by CAPA 7720 for contract-manufactured sourced finished medical device products
Review, remediate, and approve supplier process risk documentation (PFMEA) according to newly defined criteria
Review, remediate, and approve supplier process and inspection validations according to client statistical requirements
Perform change management activities to remediate gaps in supplier process risk documentation and process/inspection validations
Collaborate with suppliers and cross-functional client resources to complete approval activities
Maintain commitment to patient safety and product quality
Ensure compliance with the Quality Policy and documented quality processes and procedures
Work independently and lead supplier engineer remediation activities

Requirements

What you’ll need

Bachelor’s degree in engineering is required
2–5 years of experience in a manufacturing environment
Ability to travel up to 15% of the time; domestic travel possible
Problem-solving abilities
Manufacturing experience
Validation experience
Change management experience
Preferred: Experience working with suppliers or in supply chain management
Preferred: Experience working in the medical device field
Preferred: Experience with installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and test method validation (TMV)
Preferred: Excellent communication and project management skills
Preferred: Strong bias for action and results orientation
Preferred: Self-driven and self-motivated to learn and apply knowledge to produce results
Preferred: Understanding of statistical methods, Six Sigma methodologies, and problem-solving methodologies

Benefits

Comp & perks

Full-time schedule of 40 hours per week
Possible temp-to-hire opportunity
Hybrid work setup in Maple Grove, Minnesota
Contract length of 12 months
Opportunity to work in the medical device industry