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Supplier Quality Engineer

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

Description:

The Supplier Quality Engineer position provides overall quality assurance in the management of External Manufacturing sites engaged in the production of clients products. Further responsibilities are defined below:

Conducting audits to good manufacturing practices, international organization for standardization and any other applicable standards.

Providing complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.

Utilizing multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).

Addressing and correcting product and process complaints.

Reporting on contract manufacturer performance metrics and management reviews.

Overseeing audits of all quality system categories to assess compliance to process excellence standards.

Ensuring comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, and present reports to management.

Handling complex technical issues for manufacturing processes that are to be transferred to satellite facilities.

Providing Quality Engineering support to suppliers including inspection technique support, verification/validation activities, CAPA and change management.

Ensuring that FDA CFR Part 820 and ISO 13485 regulations/standards are understood and followed at suppliers

Qualifications:

The Supplier Quality Engineer position requires demonstrated ability to direct a team in meeting departmental goals and objectives, to make effective oral and written presentations, to prioritize and manage multiple projects consisting of varying degrees of complexity and to analyze complex problems and apply practical solutions. A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline. A minimum of 4+ years of experience in a highly regulated industry is preferred. FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred. Auditing background is an asset. Position requires strong communication, teamwork, and problem solving skills. Strong in root cause analysis skills. Experience or knowledge of machining manufacturing processes and injection molding, Six Sigma, Lean, or ASQ Certification and trainings are an asset. This position will require up to 20% travel.

Required Education

Bachelor's Degree 2+ years of experience