Quality Assurance Engineer

21 hours ago

Massachusetts, United States Stark Pharma Solutions Inc Full time

Job Title:
Quality Assurance Engineer

Location:
Mansfield, MA (Onsite)

Experience:
4 6 years

Duration:
12+ months contract

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

Position Overview
The Quality Assurance Engineer 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.

  • Aerospace Quality Assurance Engineer

    6 days ago

    Massachusetts, United States Stark Pharma Solutions Inc Full time

    Position:Aerospace Quality Assurance EngineerLocation:Newburyport, MAExperience:6+ yearsEligibility:US Citizen or Green Card holderOverviewWe are seeking a hands-on Quality Engineer to support aerospace manufacturing operations involving precision machining and complex component production. The ideal candidate is experienced in high-value, engineered...

  • Staff SW Quality Assurance Engineer

    1 week ago

    Massachusetts, United States Insulet Corporation Full time $104,000 - $156,487 per year

    Job Title:Staff SW Design Quality Assurance EngineerDepartment:Design Quality AssuranceFLSA Status:ExemptPosition OverviewThis position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of...

  • Quality Assurance Specialist

    2 weeks ago

    Massachusetts, United States Mindlance Full time $60,000 - $90,000 per year

    Job Title: Quality Assurance Associate IILocation: Framingham, MADuration: 06 months with possible extensionJob description:Internal Title: Third Party Management SpecialistSome slight flex on schedule start/ stop timeFully onsite position/ Free parking onsite*Local candidates only• Role will work with some of the smaller vendors, will reach out to and...

  • Associate Quality Engineer

    3 days ago

    Massachusetts, United States QinetiQ US Full time

    Company OverviewWe are a world-class team of professionals who deliver next generation technology and products in robotic and autonomous platforms, ground, soldier, and maritime systems in 50+ locations world-wide. Much of our work contributes to innovative research in the fields of sensor science, signal processing, data fusion, artificial intelligence...

  • Quality Engineer

    2 weeks ago

    Massachusetts, United States Intellectt Inc Full time $90,000 - $120,000 per year

    Role:Quality Engineer (Metrology)- Medical deviceLocation:Devens, MADuration:6-Month Contract on W2We're seeking aQuality Engineerwith strongmetrology and materials testingexperience to support manufacturing operations. The role involves developing and validating test methods, leading GR&R studies, resolving non conformances, and driving continuous...

  • Manufacturing Quality Engineer

    2 weeks ago

    Massachusetts, United States Stark Pharma Solutions Inc Full time $80,000 - $140,000 per year

    Position:Manufacturing Quality Engineer - AerospaceLocation:Newburyport, MAExperience:6+ yearsEligibility:US Citizen or Green Card holderOverviewWe are seeking a hands-on Quality Engineer to support aerospace manufacturing operations involving precision machining and complex component production. The ideal candidate is experienced in high-value, engineered...

  • Laboratory Quality Assurance Lead

    1 week ago

    Massachusetts Client Office (MA), United States ICF Full time $107,000 - $182,697 per year

    Laboratory Quality Assurance LeadICF is seeking a Laboratory Quality Assurance Lead to support an EPA contract, Environmental Services Assistance Team (ESAT) in Chelmsford, Massachusetts, location is a federal government lab.The team performs soil, water, air, waste, and biota sampling and analysis for chemical contaminants primarily supporting Superfund...

  • Product Engineer

    3 weeks ago

    Massachusetts, United States Theoris Full time

    JOB TITLE: Product Engineer LOCATION: Foxboro, MA INDUSTRY: Automotive Manufacturing JOB DESCRIPTION: The Product Engineer is responsible for designing and developing consumer products that are safe, intuitive to assemble, and optimized for manufacturability. This role collaborates closely with cross-functional teams to ensure product designs meet...

  • Associate Software Test Engineer

    2 weeks ago

    Massachusetts, United States Insulet Corporation Full time

    *Company Overview*Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is...

  • Director of Embedded Systems Engineering

    1 day ago

    Massachusetts, United States Cambridge Mobile Telematics Full time

    Cambridge Mobile Telematics (CMT) is the world's largest telematics service provider. Its mission is to make the world's roads and drivers safer. The company's AI-driven platform, DriveWell Fusion, gathers sensor data from millions of IoT devices — including smartphones, proprietary Tags, connected vehicles, dashcams, and third-party devices — and fuses...