Quality Engineer, Operations & Validation

CMR Surgical; Ely (MN); On-site; USD 87,014 - 120,482; Full time

Benefits offered by this job

Bonus

Pension

Healthcare

Parental leave pay

Job summary

CMR Surgical Ely site is seeking a Quality Engineer to drive the QE mindset across operations. You will own process validation, support GMP/ISO 13485 compliance, and lead key quality tools to improve manufacturing processes.

This full-time, on-site role requires cross-functional collaboration with Operations, Quality, Supplier Engineering and Technology, with occasional travel to support audits and CAPA activities; experience with MDSAP, QMS/ERP tools, and Lean Six Sigma is highly valued.

Qualifications

• Degree in science, engineering or equivalent.
• Typically 5 years Quality Engineering experience in medical devices or healthcare.
• Experience with ISO 13485 and regulatory requirements.

Responsibilities

• Own Process Validation end-to-end across the Operations team.
• Lead Quality Engineering core tools implementation and improvements.
• Address NCR/DOA/CAPA/SCAR requirements and support audits.
• Collaborate with Operations, Quality, Supplier Engineering and Technology.

Skills

SPC

MSA

FMEA

Control Plan

NCR

CAPA

Minitab

JMP

PowerBI

Netsuite

SAP

e-QMS

Lean Six Sigma

Internal Auditor

Education

Degree in science/engineering

Tools

PowerBI

Netsuite

SAP

e-QMS

Job description

CMR Surgical Ely site is seeking a Quality Engineer to drive the QE mindset across operations. You will own process validation, support GMP/ISO 13485 compliance, and lead key quality tools to improve manufacturing processes.

This full-time, on-site role requires cross-functional collaboration with Operations, Quality, Supplier Engineering and Technology, with occasional travel to support audits and CAPA activities; experience with MDSAP, QMS/ERP tools, and Lean Six Sigma is highly valued.