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Supplier Quality Engineer (Medical Device/ Regulated industry)

Company:
LanceSoft Inc.
Location:
Acton, Massachusetts, United States
Posted:
April 10, 2019

Description:

Title: Supplier Quality Engineer

Description

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned

-Conducts Component Qualifications of new or changed supplier parts

-Performs FAI for new product and product changes

-Supports suppliers with the validation of their manufacturing processes

-Conducts supplier audits and manages audit corrections

-Performs root cause analysis and implements effective corrective action for supplier nonconformances

-Establishes relationships with suppliers and actively drives continuous improvement

-Develops and implements test methods and procedures for inspecting, testing and evaluating product and processes at supplier locations

-Develops gauging methodology for products

-Performs capability studies and gage R&R

-Analyzes improvement opportunities through MRB monitoring

-Ensures products and processes comply with regulatory and QSM requirements

Skill/Experience/Education

Mandatory:

EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:

-Bachelors degree in Engineering or a technical field is preferred

-5 years experience in a regulated industry that includes FDA and ISO requirements

-ASQ certification a plus

-Displays developed communication and interpersonal skills: leadership, team orientation, ability to communicate at all levels

-Teamwork, communication, positive attitude required to support the manufacturing environment

-Ability to read and analyze technical prints and drawings

-Problem Solving ability to perform root cause analysis and implement effective corrective actions

-Ability to effectively manage and complete multiple projects simultaneously

-Ability to conduct Process Failure Mode and Effect Analysis (PFMEA)

-Excellent computer skills including but not limited to Microsoft Office Suite

QUALITY AND REGULATORY REQUIREMENTS:

-Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions

-Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations