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Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

Position Overview

We are currently accepting applications for the role of Quality System Engineer. The successful candidate will be tasked with developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulatory requirements. This position will require collaboration with cross-functional teams to identify opportunities for improvement, and promote continuous improvement initiatives throughout the organization.

Key Responsibilities

• Design and oversee quality control processes and documentation to ensure accurate and consistent procedures are followed.
• Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
• Conduct internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
• Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
• Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments.
• Design and oversee quality processes and documentation to ensure accurate and consistent procedures are followed.
• Monitor and report on system performance, track quality metrics, and ensure ongoing compliance with relevant standards.
• Participate in internal and external audits, and support the implementation of corrective and preventive actions to address identified issues.
• Manage and track Corrective and Preventive Actions (CAPA) and Non-Conformances (NC), ensuring timely resolution and documentation in accordance with regulatory requirements.
• Provide training and guidance to staff on quality system protocols, fostering a culture of quality throughout the team.
• Work closely with engineering, manufacturing, and regulatory teams to ensure the seamless integration of quality standards across departments

Qualifications

• Bachelor’s degree in engineering, Quality Management, or a related field.
• At least three years of experience working with quality systems in a regulated industry.
• Comprehensive understanding of ISO, FDA, or other applicable standards.
• Strong analytical, problem-solving, and communication skills.
• Certification in quality management, such as Six Sigma or CQE, is preferred.

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People

 

 

The anticipated base pay range for this position is :

$79,000.00 - $127,650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Company’s long-term incentive program.



Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calend