QE with CAD, FDA, Minitab

Quality Analyst

Location: Medina, NY-Onsite

Must have Skills: CAD, FDA, Minitab, Quality Engineer

Required Education & Experience
Education: Bachelor s degree in Engineering.
Experience: 3 5 years in Quality Engineering, preferably in FDA-regulated/Medical Device industries.
Regulatory Knowledge: FDA cGMP, ISO, ASQC, and change control processes.
Preferred Education &Experience
Education: Master s degree in Engineering.
Certifications: Lean Six Sigma (Green/Black Belt).
Required Technical Skills
Execution of IQ/OQ/PQ/MSA protocols for equipment, processes, and test methods.
Experience with computerized system validations.
Knowledge of FDA cGMP (21 CFR 820), ISO standards, and ASQC requirements.
Experience in change control processes and audit readiness.
Proficiency in statistical software (e.g., Minitab) for data analysis.
Ability to perform Root Cause Investigations (RCI) and corrective actions.
Ability to read/interpret blueprints and technical drawings.
Familiarity with CAD or similar engineering tools.
Application of process improvement methodologies (e.g., scrap/defect reduction).
Experience developing/deploying Quality Systems in regulated environments.
Microsoft Office Suite: Advanced skills in Word, Excel, PowerPoint, and Access.
Database Management: Ability to organize and analyze large datasets.

Required Soft Skills
Ability to present complex technical information clearly (written/verbal).
Experience defending validation projects during external audits.
Ability to prioritize tasks, manage multiple projects, and meet deadlines.
Mentorship of junior engineers.
Cross-functional teamwork with Production, Quality, and R&D teams.
Key Responsibilities:
Validation Leadership: Execute and document IQ/OQ/PQ/MSA protocols for equipment, processes, test methods, and computerized systems.
Compliance & Audits: Serve as the primary point of contact for external audits, ensuring adherence to FDA (21 CFR 820), ISO, and cGMP standards.
Process Improvement: Lead Lean Six Sigma initiatives (e.g., scrap/defect reduction) and strategic projects for new technology implementation.
Cross-Functional Collaboration: Partner with Production, Quality, and R&D teams to align on quality initiatives and root-cause investigations.
Technical Expertise: Utilize engineering tools (CAD, Minitab) and analyze data to support continuous improvement and validation efforts.
Mentorship: Guide junior engineers and provide technical support for design, qualification, and process monitoring.
Work Environment & Physical Demands:
Physical: Light lifting (up to 10 lbs.), sitting/standing/walking.
Conditions: FDA-regulated manufacturing facility; PPE (e.g., smock) required.

Disclaimer: i-Link Solutions Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability.