IntePros · 2 weeks ago
Quality Engineer I ~ GMP
Billerica, MA
Full-time
Onsite
New Grad, Entry Level
0+ years expIntePros is actively seeking qualified candidates for the position of Quality Engineer I ~ GMP. In this exciting role, you will support the Quality Management System (QMS) governing the site’s operations and contribute to the production of life-saving medical devices.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Conduct root cause analysis and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances
Collaborate with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to enhance product quality and process efficiency
Participate in risk management activities, such as Failure Modes and Effects Analysis (FMEA) for equipment and tooling
Support complaint investigations by analyzing lot history records and manufacturing processes
Support the development and execution of manufacturing change implementation plans
Ensure adherence to FDA, ISO 13485, and other relevant regulatory and quality system requirements
Document and analyze quality data to drive process improvements and operational excellence
Qualification
Required
Experience in a medical device or pharmaceutical environment
Experience with Good Manufacturing Practices and regulatory compliance
Experience with root cause analysis
Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field
0-5 yrs experience
Preferred
Internship or co-op experience in a medical device, pharmaceutical, or manufacturing environment
Knowledge of Six Sigma, Lean Manufacturing, and process improvement methodologies
Strong analytical and problem-solving skills
Ability to work collaboratively in a team environment
Basic knowledge of quality systems, statistical analysis, and process validation
Effective communication skills for documentation, reporting, and cross-functional collaboration
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
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