Quality Systems Leader: CAPA, Audits & Compliance

Zvh; Saint Paul (MN); Sur place; USD 88 000 - 121 000; Plein temps

Avantages offerts par ce poste

Health and dental coverage

401(k) Plan with company match

Employee stock purchase program (ESPP)

Paid time off 20–35 days

Résumé du poste

Baxter is seeking a Quality Systems Specialist to ensure quality, safety, and reliability of products across manufacturing, engineering, and regulatory teams. You will drive change control, investigations, audits, and CAPAs while supporting cross-site quality initiatives and continuous improvement.

The role requires a Bachelor's degree in a technical field and 5+ years in a regulated manufacturing environment, with knowledge of FDA QSR/ISO 13485.

Qualifications

• Bachelor's degree in a related technical field.
• 5+ years in medical device/pharma/regulated manufacturing quality systems.
• Experience managing CAPAs, nonconformance investigations, change controls, audits.
• Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and quality risk management.
• Strong writing, documentation review, and project prioritization skills.

Responsabilités

• Lead quality review and approval activities for change control records with risk assessments and implementation plans.
• Own and coordinate nonconformance investigations and CAPAs for timely root-cause analysis.
• Partner with cross-functional teams to resolve quality issues and maintain regulatory compliance.
• Review manufacturing, inspection, and release docs to support product disposition decisions.
• Support audits by preparing documentation and gathering evidence for outcomes.
• Monitor quality metrics, identify trends, and escalate issues impacting compliance or product quality.
• Serve as a quality systems SME, supporting document control and continuous improvement across sites.

Connaissances

Quality systems

Regulatory compliance

Root cause analysis

Documentation

Process improvement

Cross-functional collaboration

Formation

Bachelor's degree in related field

Outils

TrackWise

Adobe approvals

ERP systems

Description du poste

Baxter is seeking a Quality Systems Specialist to ensure quality, safety, and reliability of products across manufacturing, engineering, and regulatory teams. You will drive change control, investigations, audits, and CAPAs while supporting cross-site quality initiatives and continuous improvement.

The role requires a Bachelor's degree in a technical field and 5+ years in a regulated manufacturing environment, with knowledge of FDA QSR/ISO 13485.