Sr Quality Engineer

Quality Engineer

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.

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.
• 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.

Key Result Areas:

• Support implementation of corporate quality, project management, process development, and compliance procedures.
• Review and analyze validations for equipment, processes, and software.
• Communicate effectively with all levels of the organization.
• Manage and prioritize multiple projects in a fast-paced environment.
• Maintain RMFs and evaluate post-production data for impact.