Senior Quality Engineer - Med Device
- Location: Dallas, TX
- Working situation: Onsite
- Level: Senior Engineer - Individual Contributor
Our client, a mid-sized, successful and global med device firm is looking to add multiple headcount to their Quality team!
The Senior 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 be also joining a global team, working to support globally produced products primarily in the US and Europe.
The Senior 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 Senior Quality Engineer - Med Device has the following qualifications:
- Bachelor's Degree in Biology, Chemistry, Engineering, or related fields
- Minimum of 4 years of Quality experience
- Experience working in medical devices
- 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
- Lunch & Learns
- Other benefits competitive with a global company
