Quality Engineer

Overview

Stefanini Group is hiring! We are looking for a Quality Engineer in Skaneateles, NY (Hybrid/Remote).

For quick apply, please reach out to Sangeeta Dasadhikary:

• Call: 248-582-6547

• Email: [email protected]

• Work Hours: M-F (40 hours)

• Work Location: Skaneateles, NY (Hybrid if local, open to remote candidates)

• Shift: 1st Shift

Responsibilities

• Investigate, review, and complete quality engineering complaint issue analysis tasks using various quality system inputs.
• Review individual complaints and service data to determine risk levels and identify problem/cause codes.
• Analyze data from various inputs (FCA, Complaints, FDA MDRs, etc.) to determine trends and systemic issues; prepare and issue reports.
• Review investigation reports to identify and close gaps for GMP compliance.
• Develop and communicate expectations for quality performance, continuous improvement, and process controls.
• Monitor and drive corrective actions and continuous improvement activities.
• Conduct or lead corrective and preventive actions (CAPA) in manufacturing using formal problem-solving tools.
• Support CAPA and maintenance activities for existing product lines.
• Recommend and support quality system improvement projects.

Job Requirements

• Bachelor of Science degree in Engineering.
• 1-3 years of Medical Device experience.
• Knowledge of 21CFR820 preferred.
• Strong investigational research and analytical problem-solving skills (Root Cause Investigations).
• Experience with statistical software packages (Minitab a plus).
• Knowledge of FDA cGMP, ANSI/ISO/ASQC requirements, and CMDAS (optional).
• Ability to read and understand blueprints and technical drawings.
• Solid technical understanding of engineering principles (e.g., CAD).
• Computer competency in Word, Excel, PowerPoint, Minitab, Access, and databases.
• Ability to multi-task and methodically manage projects.

Physical Demands

• Must be able to sit for long periods.
• Good hand-to-eye coordination and dexterity.
• Dynamic lifting capability: Must be able to lift 40 pounds.

Work Environment

This is a manufacturing environment regulated by the FDA. Work rules include:

• Wearing a static protective smock at all times in the work area.
• Wearing a ground wrist strap plugged into the working table.
• Working in close proximity to other employees.
• Working in a temperature and humidity-controlled environment.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and nearshore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises. We operate in the Americas, Europe, Africa, and Asia, serving over 400 clients across various markets. Stefanini is a CMM Level 5 IT consulting company.

Note: Listed salary ranges may vary based on experience, qualifications, and local market. Stefanini will never make an offer of employment without a phone conversation.