Senior Quality Engineer: Validation & Packaging Excellence

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

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.