Senior Quality Engineer

JobDiva, Inc.; North Haven (CT); On-site; USD 90,000 - 140,000; Full time

Job summary

JobDiva, Inc. is seeking a Senior Quality Engineer in Connecticut to support packaging validation, equipment qualification, and process validation within a regulated manufacturing environment.

The role emphasizes IQ/OQ/PQ validation, packaging and post-sealing equipment validation, and robust QMS practices. The ideal candidate will bring 5+ years of experience in Quality Engineering or related fields, with experience in regulated industries such as medical devices or pharmaceuticals.

Qualifications

• Bachelor's degree in engineering or related technical field.
• Advanced degree or relevant 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 in a regulated manufacturing environment (medical devices, pharmaceuticals, biotech) preferred.
• Experience with packaging validation and post-sealing/packaging equipment validation.

Responsibilities

• Lead and execute equipment qualification and process validation activities (IQ/OQ/PQ).
• Develop and review validation protocols, reports, tests and acceptance criteria.
• Support packaging validation including post-sealing and packaging equipment validation.
• Provide Quality Engineering support to manufacturing operations and troubleshoot issues.
• Perform statistical analysis and process capability studies to evaluate performance.
• Support investigations of nonconformances, deviations, and CAPAs.
• Lead RCA using problem-solving methodologies.
• Develop and implement inspection and testing procedures to meet requirements.
• Ensure processes comply with QMS and regulatory requirements.
• Assist audits and inspections with validation evidence.

Skills

Quality engineering

Process validation

Statistical analysis

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Advanced degree or certifications in Quality/Validation

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.