Manufacturing Engineer

Seeking to hire a Manufacturing Engineer for a growing Medical Device Company in DFW!

Description:

Responsible for maintaining and improving the quality management system. Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products. Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements corrective actions to eliminate quality problems. Provides support and leadership to teams focused on CAPA. Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier corrective action plans. Develops various product tests and conducts data analysis. Develops qualification test protocols and generates reports as needed. Provides guidance on engineering projects. Supports the internal and external quality audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.

Skills:

-Quality assurance

-Manufacturing

-Root cause

-Ppap,

-Tooling

-Quality Plan

-Calibration

-Metrology

-Inspection

-Statistical analysis

-Vision system

-CQE

Additional Skills & Qualifications:

Requirements:

• Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience is required. Master of Science degree in Engineering or Quality Assurance is preferred.

• A minimum of 3 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical is required.

• American Society of Quality (ASQ) Certification (CQA, CQE, SSBB, etc.) preferred.

• Familiar with FDA Quality System Regulation, MDD, ISO 9001, ISO13485, and ISO 14971.

• Strong unbiased advocate of compliance.

• Ability to lead efficient project teams.

• Must possess technical writing, project management and fundamental problem-solving skills.

• Experience using word processing, spreadsheet, data management and/or design of experiments software programs. Familiarity with Minitab statistical software.

• Experience as a Lead auditor of quality management systems.

• Previous experience performing laboratory and/or mechanical testing required.

• Excellent verbal and written communication skills.

• Ability to travel up to 10% of the time.

Responsibilities:

• Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.

• Provide technical support for incoming inspection and lot release testing activities.

• Provide support and leadership to Product Improvement Teams as Quality Engineer.

• Manage customer complaint investigations from initiation through investigation and closure. Ensure reportability assessments are made in a timely manner for each complaint. Ensure quality, in-depth investigations are performed, including effective root cause and corrective action assessments.

• Manage NCMR investigations from initiation through investigation and closure. Perform product dispositions in a timely manner. Ensure quality, in-depth investigations are performed, focusing on elimination of the defect condition through effective root cause and corrective action p