What are the responsibilities and job description for the Quality Engineer position at Spherical Search?
Spherical Search is currently partnered with an i ndustry leading manufacturer of blister packaging for the pharmaceutical industry , focusing mainly on oral solid dosage.
We are currently looking for a Quality Engineer to join the team in New Castle, Delaware. The position is on-site, but we could also be open to hybrid depending on the candidate.
The Quality Engineer will have in-depth knowledge of films and foils materials and experience ensuring the quality, safety, and compliance of packaging materials used in pharmaceutical products. Added knowledge of blister packaging machines is a plus. This role focuses on product quality control, regulatory compliance, and continuous improvement with a strong emphasis on quality and cost management.
Key Accountabilities
- Operations Quality Management : Oversee quality related to the production of films and foils for primary packaging applications, ensuring strict adherence to pharmaceutical industry standards.
- Quality Control Analysis : Set up quality control analysis to confirm they meet required specifications and safety standards.
- Cross-functional Collaboration : Work closely with Production, Development and technology, Supply Chain, Safety, Quality Assurance and Regulatory affairs, and other teams to ensure the quality and integrity of packaging materials throughout production and post-production.
- Continuous Improvement : Monitor production processes, identify opportunities for improvement, and drive initiatives to optimize quality and minimize cost.
- Regulatory Compliance : Ensure compliance with cGMP, ISO 9001, ISO 15378, and other relevant standards. Lead efforts to meet regulatory requirements and quality benchmarks for pharmaceutical packaging materials.
- Requirement Analysis & Validation : Conduct requirement analysis, process validation, and system validation to ensure alignment with quality standards.
- Supplier Quality Management : Manage supplier quality processes, standardize inspection systems for incoming raw materials, in-process checks, and final inspections.
- Customer Complaints Management : Analyze customer complaints related to packaging materials and implement corrective and preventive actions to resolve issues.
- Technical Support : Provide technical expertise to troubleshoot production issues related to films and foils and assist in resolving production-related challenges.
- Industry Awareness : Stay up to date with the latest trends and technological advancements in polymer science, packaging technologies, and industry best practices.
Qualifications / Competencies
