Quality Analyst Position Available In Orleans, New York

Quality Analyst Reuben cooley 121 Ann Street, Medina, NY 14103 Required Education & 

Experience Education:

 Bachelor’s degree in Engineering.

Experience:

 /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). 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:

Full-time Pay:

$45.00 – $50.00 per hour

Benefits:

401(k) Dental insurance Health insurance

Schedule:

10 hour shift 12 hour shift 4 hour shift Day shift Evening shift 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