Bachelor's degree in Engineering or a science-related field (or equivalent work experience)
5-10 years of hands-on experience in an FDA-regulated industry (pharmaceutical, biomedical, or medical device)
Strong knowledge of GMPs, QSR, and ISO standards
Expertise in equipment/process validation, specifically IQ/OQ and protocol/report writing
Understanding of statistical methods and acceptance sampling in regulated environments
Proficient with PC tools like Word, Excel, and data analysis software
Risk Management experience preferred but not required
Responsibilities
Provide Quality Engineering leadership for new product development and tech transfer
Lead resolution of quality issues across cross-functional teams
Collect, analyze, and present statistical data for validations and engineering studies
Perform calibration activities and support preventive maintenance
Maintain Risk Management Program policies and documentation
Conduct internal and supplier audits as assigned
Analyze non-conformances and implement corrective and preventive actions
Benefits
Collaborative work environment with cross-functional teams
Opportunities for professional development and skills enhancement
Engagement in high-visibility Risk Management projects
Exposure to cutting-edge product development practices
Chance to impact product quality across multiple facilities
Full Job Description
Job Description: 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. 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
ssist 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
nalyze 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 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.
SQ, CQE, or CQA certifications preferred but not require.
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.
