Quality Engineer - Med Device
- Location: Dallas, TX
- Working situation: Onsite
- Level: Engineer - Individual Contributor
Our client, an established and successful med device company is looking to add a process improvement-focused quality professional to their Quality team!
The Quality Engineer - Med Device will help lead the post-market surveillance activities, monitor manufacturing activities, and use Lean Six Sigma & Kaizen best practices for process improvement efficiencies. This individual will also be joining a lean team and directly be reporting into the Head of Quaity, working to support globally produced products.
The Quality Engineer - Med Device will:
- Develop and implement robust quality assurance processes
- Collaborate with suppliers to ensure adherence to quality standards, conduct supplier audits, and manage supplier corrective actions as necessary
- Drive continuous improvement initiatives to enhance product quality, reliability, and efficiency, utilizing methodologies such as Lean Six Sigma and statistical process control (SPC)
- Coordinate and support internal/external audits and regulatory inspections, ensuring readiness and facilitating timely resolution of findings
- Provide quality engineering support for product design and development projects, including design reviews, verification/validation activities, and design change control
The Quality Engineer - Med Device has the following qualifications:
- Bachelor's Degree in Biology, Chemistry, Engineering, or related fields
- Minimum of 1 year of Quality experience
- Knowledge of relevant regulations and standards, including FDA QSR, ISO 13485, MDR, and other global regulatory requirements
Company Benefits:
- Competitive 401K program, health insurance, and HSA accounts
- Casual dress days
- Dynamic company culture
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