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Senior Quality Engineer

Katalyst Healthcares & Life Sciences
  • North Haven, CT
  • Instant Apply
1 day ago

Job Description

Job Summary
We are seeking a highly experienced Senior Quality Engineer to support packaging validation, equipment qualification, process validation, and manufacturing quality activities within a regulated manufacturing environment. The ideal candidate will have strong expertise in IQ/OQ/PQ validation, packaging and post-sealing equipment validation, statistical analysis, process capability, and Quality Management Systems (QMS) .

Roles & Responsibilities
  • Lead and execute equipment qualification and process validation activities, including IQ, OQ, and PQ.
  • Develop and review validation protocols, reports, test procedures, acceptance criteria, and related documentation.
  • Support packaging validation, including post-sealing and packaging equipment validation.
  • Provide Quality Engineering support to manufacturing operations and troubleshoot process and equipment-related quality issues.
  • Perform statistical analysis, process capability studies, and data analysis to evaluate process performance and identify improvement opportunities.
  • Support the investigation and resolution of nonconformances, deviations, complaints, and CAPAs.
  • Lead or participate in Root Cause Analysis (RCA) using appropriate problem-solving methodologies.
  • Develop, review, and implement inspection and testing procedures to ensure product and process requirements are met.
  • Ensure manufacturing processes and validation activities comply with applicable Quality Management Systems (QMS), regulatory requirements, and company procedures.
  • Support internal, external, and regulatory audits and inspections by providing technical documentation and validation evidence.
  • Identify opportunities for Lean Manufacturing, process optimization, and continuous improvement.
  • Collaborate with Manufacturing, Quality, Engineering, Operations, and other cross-functional teams to resolve technical and quality issues.
  • Provide technical support for equipment/process changes, validation requirements, and manufacturing improvements.
  • Prepare and maintain accurate technical and quality documentation in accordance with applicable procedures and regulatory requirements.
  • Monitor process performance and recommend corrective or preventive actions based on data and risk assessment.
  • Participate in design/process reviews, risk assessments , and change control activities as required.
Education & Experience
  • Bachelor's degree in engineering, Quality Engineering, Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Life Sciences, or a related technical field.
  • Advanced degree or relevant professional certifications in Quality, Validation, or Engineering are a plus.
  • 5+ years of experience in Quality Engineering, Manufacturing Quality, Validation Engineering, Process Engineering, or a related field.
  • Experience working in a regulated manufacturing environment, preferably within Medical Devices, Pharmaceuticals, Biotechnology, or other highly regulated industries.
  • Experience with packaging validation and post-sealing/packaging equipment validation.

Numbers & Facts

LocationNorth Haven, CT

Skills

  • Biologyunmatched
  • Biomedical Engineeringunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Cross-Functionalunmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Equipment Validationunmatched
  • External Auditunmatched
  • Identify Issuesunmatched
  • Internal Auditunmatched
  • Lean Manufacturingunmatched
  • Manufacturingunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing Requirementsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Operational Supportunmatched
  • Operations Processesunmatched
  • Performance Analysisunmatched
  • Performance Managementunmatched
  • Problem Solving Skillsunmatched
  • Process Capabilityunmatched
  • Process Engineeringunmatched
  • Process Improvementunmatched
  • Process Manufacturingunmatched
  • Process Validationunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Regulatory Requirementsunmatched
  • Requirements Validation/Verificationunmatched
  • Risk Analysisunmatched
  • Root Cause Analysisunmatched
  • Statisticsunmatched
  • Technical Supportunmatched
  • Technical Writingunmatched
  • Testingunmatched
  • Validation Documentationunmatched
  • Validation Planunmatched

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