Senior Design Quality Engineer – NPI & Risk Leader

Fortive

Irvine (CA)

On-site

USD 101,000 - 169,000

Full time

5 days ago

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Benefits offered by this job

Bonus or Equity

Job summary

Fortive is seeking a Quality Engineering professional to lead risk management, reviews of design verification and validation, and CAPA coordination within NPI and product life cycle management. The role emphasizes adherence to FDA QSR 21 CFR 820 and ISO13485, with strong cross-functional interaction across R&D, operations, and quality teams.

Applicants should have a technical degree and 3–4+ years in quality engineering within regulated industries, plus proficiency in Excel/Office tools and data

Qualifications

Bachelor’s degree in Engineering, Science, or other technical field; Engineering degree preferred.
At least 4 years of experience in Quality Assurance, Quality Engineering, or related field.
Minimum 3 years quality engineering in FDA or other regulated industry (medical device, pharma, aerospace).

Responsibilities

Owns Risk Management process and reviews design verification/validation docs.
Delivers investigations including NCs and CAPAs with cross-functional teams.
Supports design changes, NPI, and post-launch activities with quality focus.
Provides training on quality management system elements to peers.

Skills

Quality engineering

Risk management

CAPA

Design control

Statistical methods

Cross-functional collaboration

Documentation

Education

Bachelor’s degree in Engineering/Science/technical field

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Applicants should have a technical degree and 3–4+ years in quality engineering within regulated industries, plus proficiency in Excel/Office tools and data

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