Senior Quality Engineer: NPI & Manufacturing Excellence

Aphena Pharma Solutions; Easton (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

Aphena Pharma Solutions seeks a Quality Engineer to support or lead QA activities across the product lifecycle, including tech transfer into commercial operations. The QE will focus on ensuring products meet specifications and drive continual improvement in manufacturing and packaging processes.

The role collaborates with site leadership and cross-functional teams, owning investigations, CAPA, and documentation to support compliance with cGMP, ISO, and regulatory requirements.

Qualifications

• Bachelor's or higher degree in engineering or related scientific field.
• 5+ years of experience in an FDA-regulated industry, preferably medical devices or pharma.
• Strong analytical skills and proficiency with data analysis tools.

Responsibilities

• Drive and support QA activities across product lifecycle and tech transfer.
• Investigate deviations, root cause analysis, and CAPA to prevent recurrence.
• Prepare and review quality documentation (MSA, control plans, inspection plans).
• Collaborate with internal teams, suppliers, and customers to ensure product quality.

Skills

MS Office

ERP systems

eQMS systems

Statistical software

Education

Engineering or related scientific degree

Tools

MS Office

ERP systems

eQMS systems

Job description

Aphena Pharma Solutions seeks a Quality Engineer to support or lead QA activities across the product lifecycle, including tech transfer into commercial operations. The QE will focus on ensuring products meet specifications and drive continual improvement in manufacturing and packaging processes.

The role collaborates with site leadership and cross-functional teams, owning investigations, CAPA, and documentation to support compliance with cGMP, ISO, and regulatory requirements.