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)

• Shift: 1st Shift

Responsibilities

• Responsible for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.
• Review individual complaints and associated service data to determine risk level and complete investigation into the "determined" problem code and cause codes for each complaint.
• Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues. Prepare and issue reports based on information analysis.
• Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
• Develop and communicate expectations for quality performance, continuous improvement, and process controls for marketed products.
• Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
• Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
• Support CAPA and maintenance activities for existing product lines.
• Recommend and/or support projects for improvements to the quality system as approved by management.

Job Requirements

• Bachelor of Science degree in Engineering.
• 1-3 years of Medical Device experience.
• Medical Device experience with knowledge of 21CFR820 preferred.
• Investigational research skills.
• Experience with any statistical software packages (Minitab a plus).
• Desired experience in the medical device industry in the development and deployment of Quality Systems, process controls, and continuous improvement methods.
• Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional).
• Knowledge and working application of reading and understanding blueprints and technical drawings.
• Demonstrated strong analytical problem solving (Root Cause Investigations).
• Solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
• 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 of time.
• Must have good hand-to-eye coordination and dexterity.
• Dynamic Lifting: Must have the ability to lift 40 pounds at a time.

Work Environment

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

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

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near-shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Stefanini is a CMM level 5, IT consulting company with a global presence.