Quality Analyst Position Available In Orleans, New York

Quality Analyst Key2Source INC 101 North Avenue, Medina, NY 14103

Position:

Quality Analyst Type:

Contract (W2)

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.

Job Type:

Contract Pay:

From $40.00 per hour

Schedule:

Monday to Friday Night shift Ability to

Commute:

Medina, NY 14103 (Preferred) Ability to

Relocate:

Medina, NY 14103: Relocate before starting work (Preferred)

Work Location:

In person