Senior Quality Engineer

Stefanini Group is hiring!

Stefanini is looking for Senior Quality Engineer in Medina, NY

For quick Apply, please reach out to Tuhin Podder- call: /email:

Work Hours: M-F (40 hours)

Work Location: Medina, NY

Shift: 1st Shift



The Senior Quality Engineer is responsible for leading and executing complex validations, driving process improvement projects, and ensuring alignment with procedural and regulatory requirements. This role requires strong technical expertise, effective communication skills, and the ability to lead cross-functional teams. Responsibilities of this role include, but are not limited to:Lead and execute complex validations, including IQ, OQ, PQ, and MSA protocols and reports for processes, equipment, test methods, and computerized systems within the facility.Drive and provide guidance for change control processes, ensuring alignment with procedural and regulatory requirements.Act as the primary representative during external audits, presenting, defending, and communicating effectively on validation projects or quality-related initiatives.Lead process improvement projects with a focus on efficiency and effectiveness across operations, including scrap reduction and defect reduction.Collaborate effectively with cross-functional teams, including production, quality, laboratory, and service, driving alignment on quality initiatives.Demonstrate advanced technical expertise in engineering principles and procedures, utilizing tools such as CAD and specialized software in areas like chemical, industrial, or biological engineering.Lead technical reviews, organize data, and prepare comprehensive documentation for complex projects.Mentor junior level engineers and provide technical support during design, installation, qualification, and ongoing process monitoring.Develop and deliver data-driven technical reports and analyses to support continuous improvement initiatives.Drive strategic plant initiatives related to new process/technology development and implementation.Perform other duties as assigned.

A Bachelor's degree in Engineering is required, Master's degree in Engineering is preferred.3-5 years of engineering experience related to Quality, preferably in an FDA regulated environment/Medical Device industry.Proven experience in the development and deployment of Quality Systems.Medical Device Experience with knowledge of 21CFR820 preferred.Investigational research skillsExperience with any statistical software packages (Minitab a plus)Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS preferred.Knowledge and working application of reading and understanding blueprints and technical drawings.Knowledge of process improvement methodologies such as Lean Six Sigma.Strong communication skills with the ability to engage in complex technical and project management issues, both verbally and in writing.Ability to manage multiple projects simultaneously, prioritize effectively and meet tight deadlines.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:Able to exert up to 10 pounds of force occasionally.Able to sit, stand, and walk throughout the workday.



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 protective smock at all times while in the manufacturing work areaWorking 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 GroupThe 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.



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