Quality Engineer II

Job Title : Quality Engineer II

Location : Mansfield, MA (Onsite)

Experience : 4 6 years

Duration : 12+ months contract

Work Authorization : USC, GC, GC-EAD, H4-EAD

Position Overview

The Quality Engineer II will play a key role in maintaining and improving the site's Quality Management System (QMS). This role focuses on ensuring compliance with internal and external quality standards, managing nonconformance (NC) investigations, corrective and preventive actions (CAPA), and complaint handling. The engineer will work closely with cross-functional teams across manufacturing, product development, and quality to drive continuous improvement and sustain regulatory compliance within a highly regulated environment.

Key Responsibilities

Lead and support CAPA and nonconformance (NC) investigations, ensuring timely and effective closure.

Manage and prioritize a backlog of CAPAs, NCs, and complaint records, driving each to completion.

Perform root cause analysis and risk assessments to identify corrective and preventive measures.

Ensure compliance with FDA, ISO 13485, and other applicable regulatory and quality system requirements.

Collaborate with cross-functional teams including Manufacturing, Engineering, Regulatory, and Operations to implement process improvements.

Support internal and external audits, including preparation, execution, and follow-up activities.

Develop and update quality procedures, work instructions, and documentation as part of QMS improvement initiatives.

Provide quality assurance support for product development and production activities.

Monitor and report on key quality metrics and trends to identify opportunities for improvement.

Required Qualifications

Bachelor's degree in Mechanical Engineering or a related technical discipline.

4 6 years of experience in Quality Engineering, preferably within a Medical Device or Pharmaceutical manufacturing environment.

Strong understanding of Quality System Regulations (21 CFR Part 820), ISO 13485, and GMP standards.

Proven experience leading CAPA and NC processes from initiation to closure.

Skilled in root cause analysis, problem-solving methodologies, and risk management tools (e.g., FMEA, 5 Whys, Fishbone).

Strong documentation, organization, and communication skills.

Hands-on experience with QMS software tools and database management systems.

Preferred Qualifications

Prior experience in a regulated industry such as Medical Devices, Pharmaceuticals, or Aerospace.

Demonstrated ability to manage multiple projects simultaneously.

Experience working in cross-functional teams and driving results under tight timelines.

Additional Information

This position requires on-site work at the Mansfield, MA facility.

Candidate must provide Date of Birth (DOB) and the last four digits of SSN for submission.