Sr. Quality Engineer

Company : Katalyst Healthcares & Life Sciences

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.
• 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.

Requirements:

• 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.
• 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.
• 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, 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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