Senior Quality Engineer - CAPA Leader in Robotics

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

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.