Senior Quality Engineer

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

Industry: Medical Device / Pharmaceutical / Life Sciences

Employment Type: W2 Contract

Job Summary:-

We are seeking a highly experienced Senior Quality Engineer with strong experience in regulated Medical Device and Pharmaceutical/Life Sciences environments. The ideal candidate will have expertise in Quality Management Systems, CAPA, NCR/Deviation Management, Root Cause Analysis, Risk Management, Change Control, Process Validation, Supplier Quality, Audits, and Continuous Improvement.

The Senior Quality Engineer will work closely with Quality, Manufacturing, Engineering, R&D, Validation, Regulatory Affairs, Operations, and Supply Chain teams to ensure products, processes, equipment, and quality systems comply with applicable FDA, GMP/cGMP, ISO 13485, ISO 14971, EU MDR, GxP, and other regulatory requirements.

Key Responsibilities:-

• Provide Quality Engineering support for medical device, pharmaceutical, and life-sciences manufacturing operations.
• Support product and process quality throughout the complete lifecycle, from development and validation through commercial manufacturing.
• Develop, implement, and maintain Quality Management System (QMS) procedures, quality plans, specifications, work instructions, and controlled documents.
• Lead and support CAPA, NCR, deviations, complaints, investigations, and nonconformance activities.
• Perform detailed Root Cause Analysis (RCA) using 5 Whys, Fishbone, Fault Tree Analysis, and other appropriate problem-solving methodologies.
• Develop and implement effective corrective and preventive actions and monitor CAPA effectiveness.
• Conduct risk assessments and risk management activities, including FMEA and process/product risk analysis.
• Support process validation, equipment qualification, and manufacturing validation activities, including IQ/OQ/PQ.
• Review and approve validation protocols, reports, test results, and quality documentation.
• Support change control processes and evaluate quality and regulatory impact of proposed changes.
• Review manufacturing processes, procedures, batch records, inspection methods, specifications, and test methods.
• Monitor quality metrics and manufacturing trends to identify recurring issues and improvement opportunities.
• Apply SPC, statistical analysis, Lean, and Six Sigma methodologies to improve process capability and product quality.
• Support supplier qualification, supplier performance monitoring, supplier audits, and supplier corrective actions.
• Participate in internal, external, supplier, customer, and regulatory audits.
• Support audit observations, remediation activities, corrective actions, and inspection readiness.
• Ensure quality records and documentation meet applicable FDA, GMP/cGMP, ISO, EU MDR, and GxP requirements.
• Collaborate with Manufacturing, Engineering, R&D, Validation, Regulatory, Operations, and Supply Chain teams to resolve quality issues.
• Provide technical guidance and mentoring to Quality Engineers and other quality personnel.
• Drive continuous improvement projects to improve product quality, process efficiency, compliance, and reliability.
• Support the development and implementation of quality procedures for new products, processes, equipment, and manufacturing lines.
• Maintain strong awareness of regulatory expectations and industry best practices across both Medical Device and Pharmaceutical environments.

Required Qualifications:-

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

Preferred Qualifications:-

• Master's degree in Engineering, Science, Quality, Pharmaceutical Sciences, or related field.
• Six Sigma Green Belt or Black Belt certification.
• Lead Auditor certification.
• Experience with electronic QMS systems such as TrackWise, Veeva, MasterControl, ETQ, or similar platforms.
• Experience with ERP, MES, LIMS, or other manufacturing/quality systems.
• Experience supporting FDA inspections and regulatory remediation projects.
• Experience in both Medical Device and Pharmaceutical manufacturing environments is highly preferred.

Ideal Candidate Profile

The ideal candidate is a Senior Quality Engineer with strong regulated-industry experience who can operate across both Medical Device and Pharmaceutical environments. The candidate should be comfortable handling CAPA, NCRs, deviations, investigations, risk management, validation, supplier quality, audits, and continuous improvement, while ensuring compliance with applicable FDA, ISO, GMP, and GxP requirements.