Senior CAPA & PMO Quality Engineer

Teleflex; Chelmsford (MA); Hybrid; USD 127,000 - 190,000; Full time

Job summary

Teleflex is seeking a Sr. Quality Engineer (CAPA and PMO) to lead investigations of complex quality issues within CAPA, partnering with Quality, Manufacturing, Engineering, Operations, and Supply Chain.

The role requires strong analytical thinking, investigational rigor, and the ability to balance compliance with practical business needs. You will drive corrective actions, document records, and support audits.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline.
• 3–5 years in Quality, Manufacturing, Operations, or Regulatory roles in a regulated industry.
• Minimum 2 years handling CAPA investigations or quality system investigations.
• Experience with FDA/ISO 13485 and CAPA management tools.

Responsibilities

• Lead investigations and resolution activities for CAPA related quality signals.
• Perform root cause investigations using structured methods (8D, 5 Whys, Fishbone, DMAIC).
• Develop, implement, and document corrective and preventive actions.
• Ensure CAPA records comply with FDA QMSR, ISO 13485, EU MDR, and MDSAP.
• Collaborate with cross-functional partners to drive timely actions and effectiveness checks.
• Support audits and regulatory activities as needed.

Skills

CAPA investigations

Root cause analysis

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline

Tools

8D

5 Whys

Fishbone diagram

DMAIC

Job description

Teleflex is seeking a Sr. Quality Engineer (CAPA and PMO) to lead investigations of complex quality issues within CAPA, partnering with Quality, Manufacturing, Engineering, Operations, and Supply Chain.

The role requires strong analytical thinking, investigational rigor, and the ability to balance compliance with practical business needs. You will drive corrective actions, document records, and support audits.