Quality Engineer II

BASIC FUNCTION

Applies quality engineering principles and performs a variety of engineering tasks that support the

Companys Quality System, product maintenance, and new product development for the medical device industry. Supports activities in process validation, metrology, and customer/vendor issues. Assists in resolving issues that improve quality through corrective and preventive actions and makes recommendations regarding product resolution decisions.

PRINCIPLE DUTIES AND RESPONSIBILITIES

Performs engineering tasks in the implementation, compliance, and maintenance of the

Companys ISO 13485-certified quality system in a quality-focused medical device manufacturing facility.

Participates in new product development to assure quality considerations are adequately addressed, including review of blueprints and inspection documents for engineering materials and manufactured R&D parts.

Participates in the execution of First Article Inspections (FAIs), process validation inspections, Gauge R&R, or other new product development activities.

Runs the companys metrology program including maintaining calibration schedule database, coordinating calibrations with external service providers, and executing internal calibrations with calibrated standards traceable to NIST, or other approved standards.

Investigates and contributes to the close out of internal product non-conformances (NC), Corrective/Preventive Actions (CAPA), customer complaints and vendor returns. Participates in root cause analysis, drives corrective actions, and recommends product disposition decisions to Material Review Board (MRB).

Performs audits of the plant floor and Quality Management System, gathers information, and documents findings to ensure compliance with the companys quality system.

Reviews unplanned maintenance events, ensures events are properly documented, assesses calibration impact, and approves equipment for continued use.

Identifies areas for continual improvement. Participates in continuous improvement team initiatives and activities.

Maintains compliance to 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: Bachelors degree in Engineering, preferably Plastics Engineering. Six Sigma certification a plus.

EXPERIENCE: 2-4 years of experience in quality assurance, or related position in a plastics manufacturing environment and/or the medical device industry. Experience in an FDA-registered manufacturing facility a plus.

SPECIAL SKILLS: Understanding of lean manufacturing principles; proficient in reading blueprints and schematics; inspection equipment proficiency; analytical and problem-solving capabilities; effective organizational, written 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