Last - und Performancetester coordinating and executing performance tests for applications at Deutsche WertpapierService Bank AG. Collaborating with teams and ensuring software quality across systems.
OA
Hybrid Senior Engineer – Design Quality Assurance
Posted 4 hours ago
About the role
- Design Quality Assurance Engineer responsible for managing product design and compliance in medical technology industry. Collaborating across departments to meet regulatory standards and improve quality processes.
Responsibilities
- Drive the design & execution of Production Release Process project for components & finished devices
- Lead and implement complex projects including quality improvement initiatives
- Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems
- Lead Process/Design Risk Analysis
- Lead multiple product Design Control activities for new product development efforts
- Provide leadership in understanding of the quality regulations to other disciplines
- Support Process/Design Validation/Verification activities and approach including software validation
- Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting
- Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Requirements
- Bachelor’s Degree in Engineering required
- Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment
- Up to 10% domestic travel
- Strong working knowledge of technical problem solving via Six Sigma type tools to analyze, drive root cause, and solve problems
- Proven track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance
- Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab
- Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors
- Strong written and oral communication skills
- Ability to thrive in a fast-paced, dynamic and deadline-driven environment
- Well organized, flexible self-starter, team motivated and excellent at prioritizing and multi-tasking
- Skilled in presentation development and public speaking.
Benefits
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance*
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center**
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