Sr. Quality Engineer

SUMMARY

The Senior Quality Engineer serves as a technical quality leader focused on improving manufacturing performance, strengthening process controls, and driving scalable quality solutions across the organization. The role works closely with cross-functional teams to support validation activities, root cause investigations, process optimization, and quality system initiatives while promoting a culture of continuous improvement and regulatory compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Adhere to the Company's Quality Management System to ensure compliance with applicable regulatory requirements.
• Lead investigations for CAPA's, NMR's, customer complaints, etc. by ensuring that corrective and preventative actions are effective, sustainable, and measurable
• Drive the development and standardization of quality assurance and quality control processes, validation methodologies, inspection systems, and manufacturing controls across the organization
• Provide technical leadership and subject matter expertise for manufacturing process controls, inspection methods, product quality issues, etc.
• Analyze quality and manufacturing data to identify trends, recurring issues, and opportunities for improvement using statistical methods and risk-based logic
• Drive efforts related to new product development, process transfers, major scale-up activities, etc.
• Support and perform tasks related to validations
• Support and perform tasks related to documentation change processes
• Support and perform tasks related to supplier quality control
• Support and perform tasks related to the company audit program
• Provide technical guidance and mentorship to junior quality engineers as required
• Provide ongoing communication and regular status updates to senior management team
• Interface and collaborate with other departments, stakeholders, etc.
• 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.
• Promote and maintain a safe work environment by following all company safety policies, procedures, and work instructions, and by promptly reporting unsafe conditions, incidents, or concerns to supervision.
• Perform other duties as assigned.

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.

• Strong knowledge of the FDA Quality System Regulations (21 CFR Part 820) & (ISO13485: 2016).
• Working knowledge of SPC, DOE, probability, and statistics
• Prior successful testing and validation of manufacturing processes in a machining environment
• Ability to demonstrate technical expertise and communicate with internal and external customers and executive management
• Must be deadline- and detail-oriented, an effective communicator, and able to work within a team environment

EDUCATION AND/OR EXPERIENCE

• Bachelor's degree in an engineering-related field with 5+ years of experience

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

CERTIFICATES, LICENSES, REGISTRATIONS

• ASQ certification preferred (e.g., Quality Engineer, Auditor, etc.)

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.

The manufacturing environment is an industrial setting dedicated to the production and assembly of medical devices that utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. This position's time is split between office and manufacturing environments.