Senior Quality Engineer.

BASIC FUNCTION 

The Senior Quality Engineer is a key technical resource responsible for ensuring product quality throughout the manufacturing lifecycle. This highly visible position offers the opportunity to work directly with engineering, manufacturing, suppliers, and customers to solve complex quality issues, lead root cause investigations, support supplier quality improvement, and make risk-based product disposition decisions within a regulated medical device manufacturing environment.

The successful candidate will be an experienced, hands-on Quality Engineer with demonstrated expertise in manufacturing quality, supplier quality, calibration and measurement systems, risk management, and technical quality documentation.

PRINCIPLE DUTIES AND RESPONSIBILITIES

Serves as the primary Quality representative supporting manufacturing operations. 

Leads investigations of nonconforming product using structured root cause analysis methodologies.

Evaluates product quality and makes technically sound, risk-based lot disposition decisions.

Drives supplier quality improvement through SCARs, supplier investigations, and performance monitoring.

Interprets engineering drawings and specifications using GD&T principles.

Participates in PFMEA, risk assessments, process validations, and continuous improvement initiatives.

Authors technical reports, CAPAs, risk assessments, procedures, and customer communications.

Supports customer audits and quality-related customer interactions.

Manages the company’s calibration and measurement system program to ensure compliance with ISO 13485 and customer requirements.

Supports engineering changes and validation activities to ensure product quality and regulatory compliance

Maintains compliance with Pelham Plastics Quality Management System policies and procedures. Adheres to

ISO 13485 requirements for Quality Management Systems.

Performs all other duties as required or assigned.

MINIMUM REQUIREMENTS

EDUCATION: Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Quality Engineering, or a related engineering discipline required; ASQ Certified Quality Engineer preferred

EXPERIENCE: 5+ years of Quality Engineering experience in medical device or other regulated manufacturing environment.

SPECIAL SKILLS: Demonstrated proficiency interpreting engineering drawings and GD&T; experience leading CAPA and root cause investigations; strong understanding of PFMEA and risk management; working knowledge of ISO 13485; statistical analysis experience (Minitab preferred); excellent technical writing, organizational, communication, and interpersonal skills.

PHYSICAL REQUIREMENTS: Able to lift up to 20 lbs; sit, stand, bend and stoop; good visual acuity and capable of fine motor skills.