Senior Quality Engineer: Regulated Med Device & Pharma

United Consulting Hub, Inc.; Salt Lake City (UT); On-site; USD 110,000 - 160,000; Full time

Job summary

United Consulting Hub, Inc. seeks a Senior Quality Engineer with extensive experience in regulated Medical Device and Pharmaceutical/Life Sciences environments.

The ideal candidate will drive quality across the product lifecycle, ensuring compliance with FDA, GMP/cGMP, ISO 13485, ISO 14971, EU MDR, GxP, and related standards. You will lead CAPA, NCRs/deviations, investigations, risk management, and change control; develop and maintain QMS procedures; mentor junior staff; and support supplier

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Pharmaceutical Sciences, or related STEM field.
• 5-8+ years of Quality Engineering experience in regulated environments.
• Strong experience with QMS, CAPA, investigations, NCRs/deviations, RCA, risk management, and change control.
• Experience in FDA- or ISO-regulated environments.
• Strong understanding of quality and regulatory requirements for Medical Device and/or Pharmaceutical manufacturing.
• Cross-functional collaboration with Manufacturing, Engineering, Validation, R&D, Regulatory, and Operations.
• Excellent documentation, analytical, communication, and problem-solving skills.

Responsibilities

• Provide Quality Engineering support for medical device, pharmaceutical, and life-sciences manufacturing operations.
• Support product and process quality throughout development, validation, and commercial manufacturing.
• Develop, implement, and maintain QMS procedures, quality plans, specifications, and controlled documents.
• Lead CAPA, NCR, deviations, investigations, and nonconformance activities.
• Perform detailed Root Cause Analysis (RCA) using structured methods.
• Develop and monitor CAPA effectiveness and corrective actions.
• Conduct risk assessments and risk management activities (FMEA, etc.).
• Support process validation, equipment qualification, and manufacturing validation (IQ/OQ/PQ).
• Review validation protocols, reports, test results, and quality documentation.
• Support change control and evaluate regulatory impact of changes.
• Review manufacturing processes, batch records, inspection methods, specs, and tests.
• Monitor quality metrics and trending to identify issues and improvements.
• Apply SPC, Lean, and Six Sigma to improve process capability and quality.
• Support supplier qualification, supplier audits, and supplier corrective actions.
• Participate in internal, external, supplier, customer, and regulatory audits.
• Support audit observations and remediation activities.
• Ensure quality records meet regulatory requirements.
• Collaborate across functions to resolve quality issues.
• Provide guidance and mentoring to quality staff.
• Drive continuous improvement initiatives across product and process quality.

Skills

QMS

CAPA

NCR/Deviations

RCA

Risk management

Change control

Audits

Continuous improvement

SPC

Lean

Six Sigma

Education

Bachelor's degree in Engineering, Science, Quality, Pharmaceutical Sciences, or related STEM field

Tools

TrackWise

Veeva

MasterControl

ETQ

ERP

MES

LIMS

Job description

United Consulting Hub, Inc. seeks a Senior Quality Engineer with extensive experience in regulated Medical Device and Pharmaceutical/Life Sciences environments.

The ideal candidate will drive quality across the product lifecycle, ensuring compliance with FDA, GMP/cGMP, ISO 13485, ISO 14971, EU MDR, GxP, and related standards. You will lead CAPA, NCRs/deviations, investigations, risk management, and change control; develop and maintain QMS procedures; mentor junior staff; and support supplier