Design Quality Engineer II
On-siteMemphis, Tennessee, United States
Job Summary
Support product development teams by reviewing and approving engineering designs, changes, and verification protocols to ensure compliance with ISO, EU MDR, and FDA QSR requirements. Lead quality initiatives with inter-organizational impact, troubleshoot design issues, and facilitate corrective actions for customer complaints and trend analysis. Manage risk management activities focused on clinician and patient safety while performing predicate device reviews and surveillance reports. Work with cross-functional groups to resolve difficult quality problems and provide direction on quality deliverables throughout the product life cycle from concept to commercialization.
Required Qualifications
- B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering
- 2+ years of medical device experience
- M.S. degree with 1+ years of medical device experience
- Ability to interpret and apply Quality Systems Regulations and ISO quality requirements
- Knowledge of design controls
- Knowledge of 21 CFR 820
- Knowledge of ISO 13485
- Knowledge of ISO 14971
- Knowledge of EU MDR
- Knowledge of applicable medical device regulations
- Ability to plan schedules and manage multiple projects simultaneously
- Excellent communication skills
- Problem solving skills
- Organizational skills
- Interpersonal skills
- Strong technical writing skills
- Ability to work independently with minimal direction or supervision
- Ability to sit/stand for 8 hours
- Ability to sit at a computer terminal for an extended period
- On-site role in Memphis, TN
Desired Qualifications
- Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor)
- Design for Six Sigma training
- Knowledge of statistical methodologies
- Experience reviewing design verification and design validation protocols
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