Senior Quality Engineer - Medical Devices & Compliance

Regulatory Jobs; Minnesota; Presencial; USD 112.000 - 154.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

ESPP

401(k) plan

Education assistance

Paid time off

Parental leave

Commuting benefits

Employee discounts

EAP

Childcare benefits

Descripción de la vacante

Baxter is seeking a Principal Quality Engineer to provide strategic quality direction across complex manufacturing processes and product lifecycle activities. You will mentor engineers, lead investigations, and drive risk-based decisions to meet regulatory requirements and customer expectations.

The role requires advanced knowledge of FDA QSR, ISO 13485, ISO 14971, and cGMP, with experience in injection molding and multi-functional leadership. Competitive salary and benefits are offered.

Formación

• Bachelor's degree in Engineering, Science, or a related technical field.
• 5-8 years of Quality Engineering experience in regulated medical device/pharma.
• Demonstrated technical leadership for complex quality initiatives.
• Extensive knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, cGMP and risk management.
• Advanced experience with CAPA, Nonconformance, Change Control, Supplier Quality, Auditing, Validation, and Design Controls.
• Experience supporting injection molding processes in a regulated setting.
• Ability to lead multi-functional teams and influence senior stakeholders.
• Strong analytical and problem-solving skills with a track record of corrective actions.

Responsabilidades

• Lead as the Quality Engineering representative for manufacturing, sustaining, NPD, and process improvement initiatives.
• Provide strategic quality leadership for production, process development, equipment transfers, and lifecycle management.
• Lead investigations for nonconforming product, customer complaints, CAPAs, audits, and deviations.
• Act as technical authority for risk assessments, design transfers, process controls, validation strategies, and compliance decisions.
• Lead multi-functional teams to resolve quality, manufacturing, supplier, and regulatory issues.
• Support supplier manufacturing quality, including validation, process capability, control strategies, and improvements.
• Establish quality plans, risk files, inspection criteria, statistics, and monitoring systems.
• Review and approve complex quality system docs (validation reports, change controls, risk analyses).
• Oversee process validation, equipment qualification, software validation, and ongoing verification.
• Support governance forums (CAPA, Change Control, MRB) and regulatory inspections.
• Lead internal audits as Lead Auditor for FDA QSR, ISO 13485, MDSAP compliance.
• Partner with Supplier Quality on supplier qualification and performance management.
• Drive system improvements through data analysis, KPIs, trend monitoring, and Lean Six Sigma.
• Mentor Quality Engineers and cross-functional staff; influence across orgs.

Conocimientos

Quality leadership

Regulatory knowledge

CAPA & Change Control

Risk management

Nonconformance handling

Injection molding

Data analysis

Cross-functional leadership

Auditing

Leadership of multi-functional teams

Educación

Bachelor's degree

Descripción del empleo

Baxter is seeking a Principal Quality Engineer to provide strategic quality direction across complex manufacturing processes and product lifecycle activities. You will mentor engineers, lead investigations, and drive risk-based decisions to meet regulatory requirements and customer expectations.

The role requires advanced knowledge of FDA QSR, ISO 13485, ISO 14971, and cGMP, with experience in injection molding and multi-functional leadership. Competitive salary and benefits are offered.