Quality Engineer

Responsibilities

• Drive and support new customer programs throughout the development lifecycle, ensuring a seamless transition from engineering to manufacturing and supply chain.
• Collaborate with clients to support project milestones, scope changes, and business development opportunities.
• Develop and implement product and process workflows, including Design for Assembly (DFA) and Design for Manufacturing (DFM).
• Execute test method transfers, method validation activities, and the development of validation/re-qualification protocols.
• Develop sampling plans for OQ/PQ activities, including serialization and sterilization.
• Create Master Batch Records, work instructions, and associated manufacturing and packaging documentation.
• Lead root cause analysis (RCA) for deviations and complaints using data-driven methodologies.
• Manage internal and external suppliers and participate in external audits of contract service providers.

Requirements

• College or Trade Degree in engineering or a related scientific field.
• Minimum of 3 years of experience in an FDA-regulated industry (medical device or combination products preferred).
• Proficiency with MS Office, ERP, and eQMS systems.
• Strong analytical skills with the ability to perform complex Root Cause Analysis (RCA).
• Proven experience in technical writing and interpreting scientific data, charts, and graphs.
• Full professional proficiency in speaking, reading, and writing.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) certification.
• Lean Six Sigma or other formal process improvement skillsets.
• Technical knowledge regarding Test Method validation, Medical Devices, and Sterilization processes.
• Strong organizational, time management, and multitasking abilities.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, dedicated to building the bridge between life-changing therapies and patients. We invest in people who drive progress and create a better tomorrow through a culture of purposeful work and intentional learning.