Sr. Quality Engineer

Roles & Responsibilities

• Provide Quality Engineering leadership for NPD, tech transfer, and acquisitions
• Lead resolution of quality issues across cross-functional teams
• Review and approve validations for equipment, processes, and software
• Collect, analyze, and present statistical data to support validations and engineering studies
• Affirm qualifications/validations
• Perform calibration activities as required
• Partner with Facilities to ensure proper preventive maintenance
• Collaborate with manufacturing facilities as needed
• Maintain Risk Management Program policies and documentation
• Identify hazards, risk probabilities, severities, and mitigations for Risk Analyses
• Evaluate labeling, process, and product changes for RMF impact
• Maintain periodic Risk Management File reviews on schedule
• Monitor post-market data (complaints, CAPAs, NCRs, customer feedback)
• Provide investigation reports, evaluations, and risk assessments to other departments
• Maintain knowledge of applicable standards, regulations, and procedures
• Support creation and review of Design History File documents
• Execute internal and supplier audits as assigned
• Analyze non-conformances and implement corrective and preventive actions
• Execute high-visibility Risk Management projects as needed
• Partner with Sustaining Engineering to support new product development and commercial launch
• Ensure proper application of design controls, risk management, and investigation/correction of design issues
• Support translation of design input requirements into design outputs
• Own sampling plan strategy across defect types, severity, patient risk, process capability, and classification
• Review and approve verification/validation protocols and reports
• Conduct investigation, documentation, and approval of non-conformances, CAPAs, and complaints

Requirements

• Bachelor's degree in Engineering or a science-related field (or equivalent work experience)
• 5-10 years of hands-on experience, preferably in an FDA-regulated industry (pharmaceutical, biomedical, or medical device), with strong knowledge of GMPs, QSR, and ISO standards
• Main focus will be to perform validations during this growth period over the next year.
• Need this person to be specialized in equipment/process (they have a few others covering software)
• Must be strong in IQ/OQ and protocol/report writing
• Strong understanding of statistical methods and acceptance sampling in regulated environments
• Proficient with PC tools (Word, Excel, data analysis software)
• Risk Management experience preferred but not required
• ASQ, CQE, or CQA certifications preferred but not required
• Support implementation of corporate quality, project management, process development, and compliance procedures