Quality Engineer

SUMMARY

The Quality Engineer is responsible for maintaining and improving product quality through data-driven quality control processes, inspections, and defect analysis. The Quality Engineer will support continuous improvement efforts and assurance activities while maintaining compliance with industry regulations and standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Adhere to the Company's Quality Management System to ensure compliance with applicable regulatory requirements.
• Perform special assignments as directed by supervision commensurate with experience.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• Able to interpret customer requirements, engineering drawings, data sets, industry specifications, government regulations, and other technical information to ensure compliance
• Develops methods and processes for inspecting, testing, and evaluating products and equipment
• Supports R&D efforts that may include but are not limited to design review, process controls, inspection methods, validations, and other production readiness activities
• Develops and manages risk-management processes to identify and address recurring issues
• Drives internal continuous improvement efforts through strategic planning and effective use of test data
• Utilize quality tools such as SPC, FMEA, process capabilities, sampling plans, and other lean methodology to strengthen quality and drive efficiency
• Works collaboratively with cross-functional teams including both internal/external stakeholders
• Manages and investigates problem requests initiated from NCR's, CAPA's, complaints, etc.
• Drives and supports all validation efforts (IQ, OQ, PQ) relating to manufacturing and software
• Provides support to internal and external audit efforts
• Performs other duties as required
• Able to work extended hours as required
• Willing to travel when required
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

Direct Reports: Yes N/A

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Demonstrated knowledge of ISO13845, ISO14971, 21 CFR 802, ASQ/ANSI Z1.4
• Strong analytical, problem-solving, and decision-making skills
• Must be flexible and able to adapt to change
• Strong written and verbal communication skills
• Excellent interpersonal skills
• Work experience in a manufacturing environment
• Work experience in cross-functional teams
• Work experience in planning and leading projects from conception to completion
• Project collaboration experience with external stakeholders
• Ability to think creatively and analytically

EDUCATION AND/OR EXPERIENCE

• Bachelor's degree in an engineering-related field with 3+ years of experience
• Master's degree in an engineering-related field with 1+ years of experience

CERTIFICATES, LICENSES, REGISTRATIONS

• Certified Quality Engineer (CQE) preferred
• Certified Quality Auditor (CQA) preferred
• Lean Six Sigma certification preferred

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Manufacturing. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is occasionally exposed to a variety of extreme conditions. The noise level in the work environment can be loud.

PHYSICAL DEMANDS