Quality Engineer Job Cambridge area,Massachusetts USA,Engineering

Job Description:
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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