Senior Quality Engineer

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

Job summary

Highres Biosolutions in Beverly, MA is seeking a Senior Quality Engineer to lead CAPA, root cause analysis, and cross-functional quality initiatives in a regulated manufacturing environment.

You will drive CAPA from initiation to closure, facilitate device review meetings, and strengthen the QMS while collaborating with Engineering, Manufacturing, Service, and Supply Chain to prevent recurrence and ensure customer satisfaction.

Qualifications

• Bachelor’s degree in engineering or related field required.
• 5–8 years of progressive quality engineering in a regulated environment.
• Demonstrated experience leading CAPAs and root cause analysis.
• Working knowledge of ISO 9001 and QMS.
• Strong cross-functional communication and leadership.
• Proficiency with MS Office and electronic QMS/ERP systems.

Responsibilities

• Lead CAPA process from initiation to closure with verification.
• Facilitate Device Review Meetings and quality forums.
• Investigate customer complaints and nonconformances.
• Apply structured problem solving (5 Whys, fishbone, 8D).
• Evaluate nonconforming material and MRB activities.
• Develop and verify corrective actions addressing root causes.
• Maintain and improve the QMS, audits, and training.
• Support supplier quality activities and audits.

Skills

Quality leadership

Cross-functional leadership

Root cause analysis

CAPA management

Data-driven

Education

Bachelor’s degree in Engineering or related field

Tools

Microsoft Office

Electronic QMS

ERP systems

Issue tracking

BI tools

Job description

Job DetailsJob Location: CompanyOffice-US-MA-01915-01 - Beverly, MA 01915Position Type: Full TimeSalary Range: $95,000.00 - $115,000.00 Salary

About UsHighRes is a revolutionary laboratory automation leader committed to improving human health through life science robotics. Our technologies enable scientists to develop life-saving medicines, treatments, and therapies while maximizing resources and increasing output. At HighRes, we foster innovation, embrace diversity, and value the opportunity to hear every team member’s voice, ideas, and input, contributing to our continued success.

Job SummaryHighRes is seeking a collaborative and results-oriented Senior Quality Engineer to lead the investigation and resolution of product, process, supplier, and customer quality issues. In this role, you will lead the Corrective and Preventive Action (CAPA) process, facilitate Device Review Meetings, support customer complaint and nonconformance investigations, and drive effective corrective actions through closure.

The ideal candidate has strong experience with structured problem solving, root cause analysis, quality data, and cross-functional leadership within a complex manufacturing or automation environment. This position works closely with Engineering, Manufacturing, Systems Integration, Service, Supply Chain, Project Management, and other teams to strengthen the Quality Management System (QMS), improve product quality, and prevent recurrence.

Key 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 Material Review Board (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 the 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 approved 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, explaining quality processes, and ensuring timely closure of assigned actions.
• Provide quality engineering guidance to project teams throughout design, build, test, release, installation, and post-delivery support, with an emphasis on risk identification and prevention.
• Coach and mentor employees on quality requirements, investigation techniques, root cause analysis, CAPA expectations, and effective problem solving.

QualificationsRequired Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical discipline, or an equivalent combination of education and relevant experience.
• 5–8 years of progressive quality engineering or quality assurance 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.
• Ability to lead cross-functional teams, influence without direct authority, manage competing priorities, and drive actions to completion.
• Strong written and verbal communication skills, with the ability to communicate technical and quality information to employees, leadership, customers, suppliers, and auditors.
• Proficiency with Microsoft Office applications and experience using electronic QMS, ERP, issue-tracking, or business intelligence systems.

Preferred Qualifications

• Advanced degree or professional certification such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma Green Belt, or Six Sigma Black Belt.
• Experience with automated laboratory equipment, robotics, integrated systems, electromechanical products, or custom-engineered capital equipment.
• Experience supporting internal, customer, supplier, or third-party certification audits.
• Experience with supplier quality, design and process risk tools, statistical analysis, and quality metric reporting.