Sr. Quality Engineer - Katalyst Healthcares and Life Sciences : Job Details

Sr. Quality Engineer

Katalyst Healthcares and Life Sciences

Job Location : Medina,NY, USA

Posted on : 2025-08-20T07:31:03Z

Job Description :
Responsibilities:
  • 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.
  • ct 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.
Requirements:
  • 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.
  • To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.
  • Medical Device Experience with knowledge of 21CFR820 preferred. Investigational research skills.
  • Experience 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.
  • bility 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:
  • ble to exert up to 10 pounds of force occasionally.
  • ble to sit, stand, 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 a protective smock at all times while in the manufacturing work area.
  • Working in close proximity to other employees.
  • Working in an environment that is temperature and humidity controlled.
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