Senior Quality Engineer: CAPA & QMS Leader

HighRes; Beverly (MA); On-site; USD 95,000 - 115,000; Full time

Job summary

HighRes is seeking a collaborative and results-oriented Senior Quality Engineer to lead CAPA, device reviews, and customer investigations in our Beverly, MA facility. You will drive corrective actions with cross-functional teams to strengthen the QMS and prevent recurrence.

The ideal candidate brings 5–8 years of quality engineering in regulated environments, strong problem-solving and data analysis skills, and experience with ISO 9001 and risk-based methodologies.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
• 5–8 years of progressive quality engineering experience in a complex manufacturing, automation, robotics, medical device, life sciences, or similarly regulated environment.
• Demonstrated experience leading CAPAs, nonconformance investigations, customer complaint investigations, and root cause analysis activities through effective closure.
• Working knowledge of ISO 9001 requirements and experience operating within a documented Quality Management System.
• Strong knowledge of quality tools and methods, including risk assessment, data analysis, process improvement, and corrective action effectiveness verification.

Responsibilities

• Lead the CAPA process from initiation through closure, including problem definition, containment, investigation, root cause analysis, action planning, implementation, effectiveness verification, and documentation.
• Facilitate Device Review Meetings and other cross-functional quality forums by guiding quality and risk discussions, documenting decisions, tracking actions, and driving timely resolution.
• Partner with Engineering, Manufacturing, Systems Integration, Service, Supply Chain, Project Management, and other functions to investigate customer complaints, product nonconformances, field issues, and process failures.
• Apply structured problem-solving and root cause analysis methods, including 5 Whys, fishbone analysis, fault-tree analysis, Pareto analysis, and 8D, to identify systemic causes and prevent recurrence.
• Evaluate nonconforming material and product issues, support MRB activities, assess product and customer risk, and provide evidence-based recommendations for disposition and escalation.
• Develop, implement, and verify corrective actions that address both the immediate issue and underlying process or system weakness.
• Maintain and improve the QMS by supporting document and process improvements, internal audits, management review inputs, training, and compliance with procedures.
• Monitor quality performance indicators, identify adverse trends and recurring failure modes, and lead data-driven continuous improvement initiatives.
• Support supplier quality activities, including supplier corrective actions, investigation of supplier-related defects, review of supplier responses, and verification of corrective action effectiveness.
• Support internal, customer, and certification audits by preparing objective evidence and ensuring timely closure of actions.
• Provide quality engineering guidance to project teams throughout design, build, test, release, installation, and post-delivery support, with emphasis on risk identification and prevention.
• Coach and mentor employees on quality requirements, investigation techniques, CAPA expectations, and effective problem solving.

Skills

Cross-functional leadership

Structured problem solving

Root cause analysis

Data analysis

Communication skills

Quality mindset

Education

Bachelor’s degree in Engineering/Quality/Life Sciences

Tools

Electronic QMS

ERP system

Issue-tracking

BI systems

Microsoft Office

Job description

HighRes is seeking a collaborative and results-oriented Senior Quality Engineer to lead CAPA, device reviews, and customer investigations in our Beverly, MA facility. You will drive corrective actions with cross-functional teams to strengthen the QMS and prevent recurrence.

The ideal candidate brings 5–8 years of quality engineering in regulated environments, strong problem-solving and data analysis skills, and experience with ISO 9001 and risk-based methodologies.