Quality Engineer – Exempt

Begin an impactful career at our Billerica, MA site as an Entry-Level Quality Engineer. This vibrant location offers a unique opportunity to work in a thriving community known for its innovation and proximity to Boston’s rich educational and cultural resources. In this exciting role, you will support the Quality Management System (QMS) that governs the entire site’s operations. This position offers the opportunity to develop foundational experience in quality engineering while contributing to the production of life‑saving medical devices.

As part of a dynamic and collaborative team, you will engage in a variety of standard quality engineering responsibilities, including CAPA support, internal/external audits, training development, and complaint investigations. You’ll work closely with cross‑functional teams to drive continuous improvement and maintain the high standards of product quality and patient safety that define our mission.

• 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.

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.

• Internship or co‑op experience in a medical device, pharmaceutical, or manufacturing environment.
• Knowledge of Six Sigma, Lean Manufacturing, and process improvement methodologies.
• Experience with Good Manufacturing Practices (GMP) and regulatory compliance.
• 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.

Lance Soft