Senior Quality Engineer

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.

Job Requirements

Details:

• 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 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