Quality Assurance Engineer

Stefanini Group•Skaneateles, NY

15h•Hybrid

About The Position

Stefanini Group is hiring! Stefanini is looking for Quality Assurance Engineer in Skaneateles, NY (Hybrid) For quick Apply, please reach out to Rachit Rastogi - call: 2489360662/ email: [email protected] Work Hours: M-F (40 hours) Work Location: Skaneateles, NY Shift: 1st Shift Engineer, Quality Complaint Investigation has primary responsibility 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 'as '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 determining 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. Details: A 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, and 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. Display a 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, Power Point, Minitab, Access and databases. Ability to multi-task and methodically manage projects. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee: Must be able to sit for long periods of time Must have good hand to eye coordination and dexterity Physical Requirements: Dynamic Lifting capability: Must have the ability to lift 40 pounds at a time. Work Environment Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to: Wearing a 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. Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers. 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. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company. #LI-RR1 #LI-HYBRID

Requirements

A Bachelor of Science degree in Engineering
1-3 years of Medical Device experience
Investigational research skills
Experience with any statistical software packages (Minitab a plus)
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.
Display a 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, Power Point, Minitab, Access and databases.
Ability to multi-task and methodically manage projects.

Nice To Haves

Medical Device Experience with knowledge of 21CFR820 preferred.
Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.

Responsibilities

Engineer, Quality Complaint Investigation has primary responsibility 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 'as '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 determining 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.