Senior Quality Engineer

Job Title:Sr. Quality Engineer

Overview:

My client is currently seeking a Quality Engineer to join our organization. This individual is responsible for process quality, data analysis, and for the planning and execution of process improvement projects supporting various departments of the Machine Shop within the plant. Responsibilities include leading investigations into product non-conformances, developing and reporting quality system metrics, supporting Statistical Process Control (SPC) initiatives, and driving projects related to product and process quality. This position is hands-on in a fast-paced environment which will interact with multiple functions (Process Engineering, R&D, and other operational departments) as well as additional supporting quality groups to resolve quality issues.

Responsibilities:

• Lead investigations into product non-conformances, to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances.
• Work towards the improvement of product and process quality and overall customer satisfaction.
• Support the machining operations manufacturing process within the plant by assisting in quality initiatives within the operations group.
• Lead improvement activities related to product and process quality in conjunction with our Process Engineering partners, including conducting process capability studies, qualifications, and gage R&R reports.
• Assist in the implementation of Statistical Process Control (SPC) throughout the Machine Shop where appropriate with the Quality Engineers, Process Engineering and Manufacturing.
• Collect and analyze data to identify trends, guiding quality initiatives, and provide feedback to our stakeholders.
• Learn and execute product inspections with a variety of inspection equipment; Use measuring instruments, engineering drawings, procedures, workmanship standards, etc. to perform inspection of parts and assemblies.
• Maintain inspection records and compile results of all inspections for internal feedback reporting system (SAP).
• Build inspection plans using SolidWorks Inspection and Prolink software to define features and inspection methods.
• Provide guidance and ensures compliance with ISO13485 & 9001, 21 CFR Part 820 and applicable good manufacturing practice regulations within the company.

Qualifications:

Education:

• Qualified individual should have a bachelor’s degree in engineering (Mechanical or Biomedical preferred), Mathematics (Emphasis on statistical skills), Business, Science, or extensive experience in a technical field directly relating to manufacturing.

Required:

• Minimum 7 years of experience in Quality Assurance or related field.
• Working knowledge of mechanical drawings (Geometric Dimensioning and Tolerancing - GD&T)
• Project management skills, exceptional organizational and time management skills, attention to detail, critical thinking and problem-solving skills, and commitment to client satisfaction are essential.
• Ability to work independently across multiple organizations.
• Strong communication skills
• Machining and/or Manufacturing exposure
• Statistical Knowledge
• Minitab/SolidWorks/Prolink

Desired Qualifications:

• Zeiss Calypso CMM Programming
• FDA 21 CFR 820 / ISO13485 / ISO 9001 / cGMP knowledge base
• Operational Excellence/Six Sigma/Lean training or certifications
• Knowledge of various sampling plans
• Knowledge of various quality systems

No sponsorship visa (H1-B, etc) candidates at this time, sorry.


Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:


COYOTE TECHNICAL & EXECUTIVE SOURCING
Phil Montoya
Director of Sourcing

Quality Engineer – Boston, MA

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