- Responsible as part of a cross-functional team for developing, applying, revising and maintaining quality and regulatory standards for designing and processing materials/products into partially or finished medical device products.
- Implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Diagnose and resolve manufacturing and quality system issues.
- Participate in performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
- Generate and maintain risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents.
- Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA.
- Support Product/ Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data.
- Write Process Validation Protocols, Analyze data and write and release Process Validation Reports.
- Communicate with Customer as needed on Design and Development Responsibilities, Quality Issues and or Supplier Initiated Change Requests.
- Support Hosting of External Customer and or Notified Body Audits as applicable.
- Investigate and manage customer field complaints, SCAR's and internal CAPA's as needed.
- Represent Quality Assurance for Non-Conformance Report dispositions, and participate in monthly Oversight Review Boards as needed.
- Provide training on quality system procedures and industry regulations/best practices.
- Interface with customers and suppliers as needed for quality issues and project requirements.
- Follows all safety and production standard operating procedures.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
- BS in a related engineering discipline; and 9 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience
- MS in a related engineering discipline and 6 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience 5+ years experience in Medical Device Product Development 5+ years experience with FDA, ISO 13485 and EU MDR Design Control requirements
- Demonstrated knowledge of and practical application of ISO 14971 and IEC 62366 requirements
- Strong statistical data analysis skills using Minitab
- Competent in Microsoft Office applications
-
Senior Staff Accountant
1 day ago
Alliance Transportation Group, LLC Austin, United StatesJob Description · Job DescriptionThe Senior Staff Accountant will be responsible for: · Month end closing along with G/L accounting, reconciliation, and · Maintaining fixed asset records and calculating and booking depreciation. · Supporting annual audit, tax filings, Review of F ...
-
Senior Staff Accountant
1 week ago
Black Ink Business Services, LLC Austin, United StatesWho We Are · Black Ink is a full-service Business Operations firm that provides consulting, accounting, and financial services. We guide our clients from start-up to growth and the occasional exit. Our roots started in NYC serving our long and diverse client list of leaders in m ...
-
Senior Staff Accountant
22 hours ago
Life Line Screening Austin, United StatesJob Description · Job Description · Senior Staff Accountant · We are seeking a detail-oriented Senior Staff Accountant to join our Finance department. This full-time position reports to the Accounting Manager and is responsible for general accounting, including preparing journal ...
-
Senior Staff Accountant
1 day ago
Acutronic USA Austin, United StatesJob Description · Job Description Join our Team · We offer 100% employer-paid benefits and an opportunity to work on cutting edge technologies in a dynamic team · Acutronic is looking for a Senior Staff Accountant to join our team in Austin, TX. In this role, you will directly su ...
-
Senior Staff Engineer
11 hours ago
Nagarro Austin, United StatesCompany Description · We are a Digital Product Engineering company that is scaling in a big way We build products, services, and experiences that inspire, excite, and delight. We work at scale - across all devices and digital mediums, and our people exist everywhere in the world ...
-
Sumo Logic Austin, United StatesSummary of role · Develop and operate our planet-scale Kubernetes Platform for running Sumo Logic's microservices to power our Observability and Security products across the world. Provide consistent and seamless interfaces that enable our microservices to leverage key Kubernetes ...
-
Senior Staff Accountant
1 week ago
efficiently Austin, United StatesJob Description · Job DescriptionWho We Are: · A little bit about us. Efficiently is a USA-based productivity partner that provides tools and solutions to increase business effectiveness for our clients. We are currently working with more than 100 US-based clients and have employ ...
-
Senior Staff Accountant
5 days ago
.efficiently Austin, United States Full timeWho We Are: · A little bit about us. Efficiently is a USA-based productivity partner that provides tools and solutions to increase business effectiveness for our clients. We are currently working with more than 100 US-based clients and have employees in over 10 countries. We have ...
-
Senior Staff Data Scientist
1 week ago
Vericast Austin, United StatesCompany Description · Vericast is a big data company. We receive on average over 100 billion intent signals daily, which assist in generating a deep understanding of a person's interest and in-market signals across 1,300 interest topics. This is coupled with strong geographic ta ...
-
Senior Staff Backline Engineer
4 days ago
Cloudera Austin, United StatesBusiness Area: · Support Seniority Level: · Mid-Senior level Job Description: · At Cloudera, we empower people to transform complex data into clear and actionable insights. With as much data under management as the hyperscalers, we're the preferred data partner for the top co ...
-
Senior/Staff Backend Engineer
2 weeks ago
Diligent Robotics Austin, United StatesWhat we're doing isn't easy. But nothing worth doing ever is. · Imagine a future powered by robots that work seamlessly with teams of humans. Every day you build onto an artificial intelligence system that improves how robots adapt to dynamic human environments. Join Diligent Ro ...
-
Senior Member of Technical Staff
1 week ago
Oracle Austin, United StatesWhat is Observability Group at OCI? · The Observability organization at Oracle's Cloud runs multiple services that operate at high scale in a broadly distributed multi-tenant cloud environment. In the observability space, we are addressing complex, large scale and connected event ...
-
Senior Member of Technical Staff
1 week ago
Oracle Austin, United StatesCloud Engineering Infrastructure Development · Oracle's Cloud Infrastructure team is building services that operate at high scale in a broadly distributed multi-tenant cloud environment. Our customers run their businesses on our cloud, and our mission is to provide them with best ...
-
Senior Member of Technical Staff
1 week ago
Oracle Austin, United StatesOverview · Are you a creative person who loves a challenge? Solve the complex puzzles you've been dreaming of as our Sr. Software Engineer - OCI. If you have a passion for innovation in tech, we want you on our team Thrive in this crucial role. · Oracle is a technology leader tha ...
-
Senior Member of Technical Staff
1 week ago
Oracle Austin, United StatesOracle Cloud Infrastructure Data Platform · At Oracle Cloud Infrastructure (OCI), we build the future of the cloud for Enterprises as a diverse team of fellow creators and inventors. We act with the speed and attitude of a start-up, with the scale and customer-focus of the leadin ...
-
Auditor (Senior, Staff, and Associate)
5 days ago
Texas Department of Aging & Disability Services Austin, United StatesJob Description: · Make an impact with a career in audit The Texas Office of Inspector General was established to combat fraud, waste, and abuse in publicly funded state Health and Human Services programs. We are looking for talented, innovative and driven people who believe they ...
-
Senior Member of Technical Staff
1 week ago
Oracle Austin, United StatesBuilding off our Cloud momentum, Oracle has formed a new organization - Oracle Health & AI. This team will focus on product development and product strategy for Oracle Health, while building out a complete platform supporting modernized, automated healthcare. This is a net new li ...
-
Senior Member of Technical Staff
1 week ago
Oracle Austin, United StatesCloud Engineering Infrastructure Development · At Oracle Cloud Infrastructure (OCI), we build the future of the cloud for Enterprises as a diverse team of fellow creators and inventors. We act with the speed and attitude of a start-up, with the scale and customer-focus of the lea ...
-
Senior Member of Technical Staff
1 week ago
Oracle Austin, United StatesThe Oracle Cloud Infrastructure (OCI) team can provide you the opportunity to build and operate a suite of massive scale, integrated cloud services in a broadly distributed, multi-tenant cloud environment. OCI is committed to providing the best in cloud products that meet the nee ...
-
Senior Staff Android Engineer
1 week ago
PayPal Austin, United StatesWhat you need to know about the role: · We are seeking an experienced and highly skilled Senior Mobile Engineer with an in-depth understanding of the NFC payment ecosystem to join our dynamic fintech engineering team. · Meet our Team: · We are the PayPal Mobile Engineering Tea ...
Quality Engineer, Senior Staff - Austin, United States - Confluent Medical Technologies
Description
Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production.
Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering and manufacturing.
Our primary capabilities include:
Nitinol components, balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.
We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.
We're looking for a Quality Engineer, Senior Staff to join our Austin, TX TeamAs a uniquely qualified candidate, you will:
Ensure that compliance to customer, risk management, quality and design control requirements is demonstrated in design and development projects. Help to ensure successful transfer of the design to manufacturing.
Work on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors, knowledge of industry regulations and best practices, and critical thinking skills.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
EXPERIENCE:
Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation across Silicon Valley and throughout the medical device industry around the world We welcome eager and ambitious team players to apply.
We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.
Confluent Medical Technologies is an equal opportunity employer.
#J-18808-Ljbffr