Sr Quality Engineer

About the role

This position utilizes Quality Engineering and Quality Assurance techniques to support new product development (NPD), product line maintenance, quality initiatives for new acquisitions, and overall Risk Management Program upkeep. The role ensures compliance with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

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
• Assist in developing, implementing, and documenting 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
• Ensure periodic Risk Management File reviews occur on schedule
• Evaluate labeling, process, and product changes for RMF impact
• 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
• Perform 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
• Establish and/or maintain Risk Management Files for product lines and corporate projects
• Review and approve verification/validation protocols and reports
• Conduct investigation, documentation, and approval of non‑conformances, CAPAs, and complaints

Qualifications

• 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)
• Strong knowledge of GMPs, QSR, and ISO standards
• Experience performing validations, especially IQ/OQ, and protocol/report writing
• Proficiency with PC tools (Word, Excel, data analysis software)
• Risk Management experience preferred but not required
• ASQ, CQE, or CQA certifications preferred but not required

Skills

• Statistical methods and acceptance sampling in regulated environments
• Collecting, analyzing, and presenting statistical data to support validations and engineering studies
• Developing, implementing, and documenting qualifications/validations
• Calibration activities and coordination of preventive maintenance
• Risk Management File (RMF) maintenance and risk analyses
• Evaluation of labeling, process, and product changes for RMF impact
• Monitoring post‑market data (complaints, CAPAs, NCRs, customer feedback)
• Execution of internal and supplier audits
• Analysis of non‑conformances and implementation of corrective/preventive actions
• Execution of high‑visibility risk management projects
• Collaboration with Sustaining Engineering for new product development and commercial launch
• Application of design controls and investigation/correction of design issues
• Translation of design input requirements into design outputs
• Sampling plan strategy across defect types, severity, patient risk, process capability, and classification
• Review and approval of verification/validation protocols and reports
• Investigation, documentation, and approval of non‑conformances, CAPAs, and complaints
• Effective communication with all levels of the organization
• Project management and prioritization in a fast‑paced environment