About the role
Job Summary
We are looking for a
Sr. Packaging Engineer
with
4+ years of experience
in the
medical device industry
to support packaging manufacturing and validation activities. The ideal candidate should have strong experience in
equipment qualification (IQ), process validation (OQ/PQ), statistical analysis, and regulated quality documentation. Experience with
DOE (Design of Experiments)
and medical device regulations is highly preferred.
Key Responsibilities
- Perform
Equipment Installation Qualification (IQ),
Operational Qualification (OQ),
and
Performance Qualification (PQ). - Execute and document
process validation
activities for packaging and manufacturing processes. - Analyze validation data using
statistical methods
and prepare validation reports. - Develop and maintain
SOPs,
validation protocols, and quality records. - Support
change control,
equipment qualification, and continuous process improvements. - Collaborate with Manufacturing, Quality, and Engineering teams to ensure compliance.
- Ensure compliance with
FDA, ISO 13485, ISO 14971,
and other medical device quality standards.
Required Skills
- Equipment Qualification (IQ)
- Process Validation (OQ/PQ)
- Process Validation Lifecycle
- Statistical Analysis & Data Interpretation
- Regulated Quality Documentation
- SOP Development
- Change Control
- Microsoft Office (Excel, Word, PowerPoint)
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