Quality Engineer Job Cambridge area,Massachusetts USA,Quality Assurance

CAPA Quality Engineer

We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a minimum of five years of relevant experience and can quickly add value from day one.

Responsibilities:

Heavy focus on CAPA (Corrective & Preventive Action) execution.
Own CAPA records from investigation through closure.
Perform root cause analysis, issue assessment, and quality problem-solving.
Manage a portfolio of CAPAs end-to-end.
Partner with CAPA owners / cross-functional teams.
Conduct investigations + drive closure activities.
Review data sources and ensure thorough documentation/compliance.

Must-Have Skillset:

Strong CAPA background (non-negotiable).
ISO 13485 experience (medical device/regulatory environment).
Technical/STEM background.
Proven communication skills (highly emphasized due to fast-paced environment).
Ability to work independently and hit the ground running.

Nice-to-Have:

Project management experience (tracking, prioritization, coordination).

Traits for Success:

Strong communication + stakeholder management (critical).
Ability to handle multiple CAPAs simultaneously.
Detail-oriented with strong quality systems mindset.

Qualifications:

Must have Engineering degree
- Technical experience and STEM related background.

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