Senior Quality Engineer — Medical Devices & Validation

Röchling Medical

Rochester (MN)

Hybride

USD 85 000 - 110 000

Plein temps

14 jours+

Générateur de candidature

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Résumé du poste

Röchling Medical is seeking a Quality Engineer to support validation and quality assurance activities in a regulated manufacturing environment. You will contribute to IQ/OQ/PQ submissions, document protocols, and perform data analysis to drive improvements.

The role requires collaboration with suppliers and customers, and leadership in CAPAs and audits. You will develop control plans, PFMEA, and risk documentation, and use Minitab for capability analyses while navigating FDA/ISO requirements and

Qualifications

Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline.
5 years of Quality Engineering experience in a regulated manufacturing environment.
Familiarity with FDA 21 CFR Part 820/QMSR and ISO 13485 is required.
Strong analytical and problem-solving skills with leadership ability.

Responsabilités

Support IQ/OQ/PQ submissions and validation activities.
Document IQ, OQ, PQ protocols and submissions.
Perform data analysis and capability studies using Minitab (ANOVA, Capability Analysis).
Develop control plans, PFMEA, and risk documentation.
Lead internal and external quality audits and supplier audits.
Drive quality improvements and implement inspection strategies.
Train staff on process changes and SOP updates.
Collaborate with suppliers and customers on quality issues and CAPAs.