Senior Quality Engineer

Senior Quality Engineer

  Not Disclosed

  Medina, NY

  6.0 Months

  Not Disclosed

  Not Disclosed

  Pharmaceutical

  $60.71/hour - $65.71/hour

Job Description

Description:

I. SUMMARY:

• This description outlines the employment prerequisites and job responsibilities for the position of Sr. Engineer, Quality.

II. ESSENTIAL FUNCTIONS:

• 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.

III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

• 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.

IV. EDUCATION/EXPERIENCE REQUIRED

• 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.

V. PHYSICAL DEMANDS

• Able to exert up to 10 pounds of force occasionally.
• Able to sit, stand, walk throughout the workday.

VI. 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.
• The client 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.

Notes:

Shift - 1