Senior Quality Engineer

We are seeking an experienced Quality Engineering professional in the medical device manufacturing industry to serve as Project Lead for the development and harmonization of an endotoxin testing strategy across three manufacturing sites. This role will lead and execute risk-based technical assessments in compliance with AAMI ST72 and USP <85>, author key technical documentation, and coordinate cross-functional implementation activities including laboratory, manufacturing, quality systems, and ERP (SAP) updates.

Key Responsibilities

• Lead the development of risk-based endotoxin testing strategies in accordance with AAMI ST72 and USP <85>.
• Author high-quality technical documentation, including:
• Technical risk assessments
• Scientific justifications
• Protocols, reports, and implementation plans
• Apply biological and microbiological principles (e.g., microorganisms, material properties, environmental conditions) to assess and control endotoxin risk.
• Serve as cross-site project lead, coordinating activities across three manufacturing locations to harmonize testing strategies.
• Drive project execution by:
• Establishing timelines, milestones, and deliverables
• Tracking progress and mitigating risks
• Ensuring on-time completion of commitments
• Partner with Quality Control, Microbiology, Manufacturing, Supply Chain, and IT teams to:
• Implement operational changes
• Modify testing workflows
• Execute required SAP / ERP updates
• Support change management activities, including change controls, training content, and system updates.
• Act as the primary technical point of contact for endotoxin strategy questions and decisions.

• B.S. in Biomedical Engineering, Biological Sciences, Microbiology, or a related technical discipline.
• 3+ years of experience in a medical device Quality Control or Quality Engineering role, with hands-on exposure to microbiology or endotoxin testing programs.
• Minimum 5 years of experience in the medical device manufacturing industry.
• Proven experience developing and implementing new or revised quality processes.
• Demonstrated capability leading cross-functional, cross-site projects.
• Strong working knowledge of medical device quality systems and regulatory expectations.
• Excellent technical writing skills, with the ability to clearly communicate complex scientific and regulatory concepts.

Preferred Qualifications

• Endotoxin testing principles (LAL, risk-based strategies)
• Applicable standards (USP <85>, AAMI ST72)
• Extensive experience in technical report writing and leading complex cross-functional and cross-site initiatives.
• Working knowledge of ERP systems (SAP preferred), including QC master data, inspection plans, or test method configuration.
• Strong organizational, communication, and stakeholder-management skills.
• Ability to operate independently while influencing without direct authority.
• Familiarity with ISO 13485 quality management systems
• Experience supporting change control and validation activities related to test method changes.
• Lean Six Sigma Green Belt or equivalent continuous improvement experience

• This is a 12-month onsite assignment with standard business hours (8:00 AM – 5:00 PM).