Quality Engineer

SUMMARY

The Quality Engineer provides on-site quality engineering support within a regulated manufacturing and distribution environment. This role supports quality assurance, quality control, supplier quality, and Quality Management System (QMS) activities across the product lifecycle for regulated medical devices, EPA-regulated products, and commercial dental products.

The Quality Engineer partners cross-functionally with Operations, Engineering, Regulatory Affairs, Supply Chain, and Customer Support to ensure products and processes meet internal requirements and applicable U.S. and international regulations. This position may support activities related to in-house manufacturing, contract manufacturing, labeling and repackaging operations, and post-market quality processes.

ESSENTIAL DUTIES

Quality Systems & Compliance

• Support maintenance and continuous improvement of the Quality Management System in accordance with applicable regulations and standards (e.g., ISO 13485, FDA Quality System Regulation/Quality Management System Regulation, EU MDR, MDSAP, EPA regulations as applicable).

• Assist with management review inputs, quality metrics, and data analysis to monitor QMS effectiveness.

• Support document control activities including review and approval of procedures, forms, specifications, and records.

• Participate in internal audits and support external audits and inspections by regulatory agencies and notified bodies.

Production & Process Quality

• Provide day-to-day quality engineering support to manufacturing, labeling, packaging, and distribution operations.

• Ensure compliance with established procedures during production, testing, labeling, repackaging, and release activities.

• Support process validations, test method validations, and equipment qualifications as required.

• Review and approve Device History Records (DHRs), batch records, and related quality documentation, as applicable.

• Support calibration systems to ensure measuring and test equipment is maintained and compliant.

Supplier & Contract Manufacturer Oversight

• Support supplier qualification, monitoring, and performance evaluation activities.

• Assist with supplier audits and management of supplier corrective actions.

Risk Management & Investigations

• Lead or support investigations related to nonconforming product, deviations, complaints, and audit findings.

• Apply structured problem-solving methodologies (e.g., 8D, root cause analysis, FMEA) to identify and implement effective corrective and preventive actions (CAPA).

• Analyze quality data and trends to proactively identify risks and improvement opportunities.

Post-Market & Regulatory Support

• Support complaint handling, feedback evaluation, and post-market surveillance activities.

• Provide quality input into regulatory submissions, product changes, labeling updates, and technical documentation.

• Assist with implementation of regulatory requirements such as UDI, vigilance reporting, and field actions/recalls, as applicable.

Continuous Improvement

• Identify and implement process and system improvements that enhance product quality, compliance, and operational efficiency.

• Promote a culture of quality and compliance through collaboration, training support, and cross-functional engagement.

KNOWLEDGE, SKILLS, AND ABILITIES

• Direct experience with ISO 13485:2016, FDA QSMR, EU MDR, MDSAP, and their application in a manufacturing environment preferred.

• Strong analytical skills with the ability to interpret data and provide actionable insights for quality improvement.

• Strong understanding of quality control principles (8D RCA, FMEA, etc.), inspection techniques, and testing methodologies.

• Ability read and interpret technical drawings, engineering specifications, and inspection/test protocols.

• Effective verbal and written communication skills to convey quality standards and regulatory requirements across departments.

• Ability to measure, record, and interpret results from various instruments used in quality control such as calipers, tape measures, Go/No Go, and other equipment.

• High level of attention to detail, particularly when reviewing technical documentation and product specifications.

• Demonstrated ability to mentor and provide guidance to cross functional team members, fostering a collaborative and supportive work environment.

• Proficiency with Microsoft Office Suite and quality management software systems.

QUALIFICATIONS / REQUIREMENTS

• Bachelor’s degree in engineering or a related technical field.

• Equivalent combinations of education and experience may be considered.

• 3-5 years of experience in a regulated manufacturing environment, preferably within medical devices, pharmaceuticals, or dental industry products.

• Relevant quality certification from recognized body such as ASQ CQE, CQA, or others desired.

WORKING CONDITIONS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Mix of office, warehouse, and production environments.

• Physical Requirements: Able to lift equipment up to 15 lbs. as necessary; prolonged periods of sitting at a desk and working on a computer. Prolonged periods standing and moving around. Wear appropriate PPE when needed such as eye protection, hair nets, respirator, face mask, and gloves.

This is an onsite position located in Northborough, MA.