Quality Engineer
2 weeks ago
This role will provide compliance support to the Regulatory Affairs organization by:
- Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
- Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
- Supporting quality system integration for acquisitions and new product introductions.
- Identifying and implementing system and/or systemic processes.
- Supporting tracking and maintenance of regulatory post-approval commitments.
- Driving quality system process improvement initiatives
Initiatives include but are not limited to:
- Establishing audit support for integration products,
- Improving and Maintaining the quality system procedures (e.g., change management)
Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a plus.
List of tasks:
- RA Change Requests Tracking and Closure
- Change management
- Develop and implement an “auditing plan” for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.
- CAPAs/Auding Finding management.
- Post-Approval Commitments management
- Support QMS audits from an RA perspective
- Support QMS Integration tasks
- Management Review Metrics results
- Ability to drive a problem through resolution and implement mitigations.
Browse our website below for additional information on our company.
The Fountain Group
4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r
\r
Browse our website below for additional information on our company.\r
\r
The Fountain Group\r
\r
4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”
-
Quality Engineer
1 week ago
Santa Clara, United States Diverse Lynx Full timeJob Title: Quality Engineer Location: Santa Clara, CA//Onsite Duration: Full Time-OnlyJOB DESCRIPTION: Job Title Quality Engineer Relevant Experience (in Yrs) 3+ years of work experience in the Medical Device industry in IQC field Must Have Technical/Functional Skills • Strong knowledge on GD&T (Geometric Dimensioning &Tolerancing) • Good understanding...
-
Quality Engineer
3 days ago
Santa Clara, United States Diverse Lynx Full timeJob Title: Quality EngineerLocation: Santa Clara, CA//OnsiteDuration: Full Time-Only JOB DESCRIPTION: Job Title Quality Engineer Relevant Experience (in Yrs) 3+ years of work experience in the Medical Device industry in IQC field Must Have Technical/Functional Skills •Strong knowledge on GD&T (Geometric Dimensioning &Tolerancing) •Good understanding of...
-
Vehicle Quality Engineer
3 days ago
Santa Clara, United States Diverse Lynx Full timeRole: Vehicle Quality Engineer Locations: Novi, MI Types: Fulltime/Permanent Minimum Experience - 4 - 6 Years Experience Required 5+ years of experience in a Manufacturing/Engineering/Operations Quality role in the automotive/transportation OEM or Tier supplier manufacturing arena. Ability to work independently, identifying and addressing problems with...
-
NPI Quality Engineer
3 weeks ago
Santa Clara, United States NVIDIA Full timeOur technology has no boundaries! Nvidia is building the world’s most groundbreaking and state of the art compute platforms for the world to use. It’s because of our work that scientists, researchers and engineers can advance their ideas. At its core, our visual computing technology not only enables an amazing computing experience, but it is also energy...
-
Manager, Customer Quality Engineering
1 week ago
Santa Clara, United States NVIDIA Full timeManager, Customer Quality Engineering page is loaded Manager, Customer Quality Engineering Apply locations US, CA, Santa Clara time type Full time posted on Posted 5 Days Ago job requisition id JR1979253 We are looking for a Customer Quality Engineering Manager in a management role to support, grow, and enhance our customer quality assurance activities from...
-
Quality Engineer III
4 weeks ago
Santa Clara, California, United States FUJIFILM Dimatix, Inc Full timeThis position strives to improve the yield of MEMS inkjet products by focusing on enhancing process control, eliminating defects and strengthening quality control.A quality engineer will support the development of next generation MEMS devices; provide technical support and guidance for process sustaining and development activities, and participate in...
-
Medical Device Quality Engineer I
6 days ago
Santa Clara, United States Anatomage Full timeWho is Osteoid?Osteoid is creating the next generation of seamless and connected 3D dental imaging software and solutions that help accelerate the path to digital dentistry. Proven in over ten years of use by thousands of labs and dental practices, Osteoid's software and hardware tools keep dental practices and labs ahead of the curve and allow dentists to...
-
Medical Device Quality Engineer I
19 hours ago
Santa Clara, United States Anatomage Full timeWho is Osteoid? Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.Osteoid is creating the next generation of seamless and connected 3D dental imaging software and solutions that help accelerate the path to digital dentistry. Proven in over ten years of use by thousands of labs and...
-
Medical Device Quality Engineer I
7 days ago
Santa Clara, United States Osteoid Inc Full timeJob DescriptionJob DescriptionSalary: $75,000 to $78,000About the RoleWe are looking for a Quality Engineer or Specialist to join our rapidly expanding team. As a member of our Quality & Regulatory team, you’ll be responsible for developing and maintaining our quality system for our medical device products. Together as a team, you’ll help ensure our...
-
Medical Device Quality Engineer I
2 weeks ago
Santa Clara, United States Anatomage, Inc. Full timeJob DescriptionJob DescriptionWho is Osteoid?Osteoid is creating the next generation of seamless and connected 3D dental imaging software and solutions that help accelerate the path to digital dentistry. Proven in over ten years of use by thousands of labs and dental practices, Osteoid’s software and hardware tools keep dental practices and labs ahead of...
-
Senior Hardware Customer Quality Engineer
6 days ago
Santa Clara, United States Nvidia Full timeWe are looking for a Hardware Customer Quality Engineer in an individual contributor role to support our customer quality assurance activities, stationed in Santa Clara, California! Your main role will be establishing a working level relationship with your customers, collaborating with customers on problem resolutions/complaints, and you will be the voice of...
-
Senior Hardware Customer Quality Engineer
2 days ago
Santa Clara, United States NVIDIA Full timeWe are looking for a Hardware Customer Quality Engineer in an individual contributor role to support our customer quality assurance activities, stationed in Santa Clara, California! Your main role will be establishing a working level relationship with your customers, collaborating with customers on problem resolutions/complaints, and you will be the voice of...
-
System Software Quality Engineer
2 days ago
Santa Clara, United States Mindlance Full timeJob Description: Top 5 Required Skills 1. Extensive experience with test case automation 2. Extensive experience with C, Python and/or other test automation programming platforms 3. Experience with Design, develop, execute and maintain software tools and automated test suites for the purpose of verifying quality and compliance 4. Experience using deductive...
-
Sr Director of Quality and Reliability
5 days ago
Santa Clara, United States Natron Energy Full timeWe are seeking a highly experienced and dynamic individual to join our team as the Senior Director of Quality and Reliability. In this role, you will play a pivotal leadership role in championing a culture of quality excellence and driving the design and testing processes to ensure product reliability. You will lead a team of talented professionals and...
-
System Software Quality Engineer
1 week ago
Santa Clara, United States Mindlance Full timeJob Description: Top 5 Required Skills 1. Extensive experience with test case automation 2. Extensive experience with C, Python and/or other test automation programming platforms 3. Experience with Design, develop, execute and maintain software tools and automated test suites for the purpose of verifying quality and compliance 4. Experience using deductive...
-
Medical Device Quality Engineer I
3 weeks ago
Santa Clara, California, United States Anatomage, Inc. Full timeWho is Osteoid? Osteoid is creating the next generation of seamless and connected 3D dental imaging software and solutions that help accelerate the path to digital dentistry. Proven in over ten years of use by thousands of labs and dental practices, Osteoid’s software and hardware tools keep dental practices and labs ahead of the curve and allow dentists...
-
Sr Software Engineer
3 days ago
Santa Clara, United States Palo Alto Networks Full timeJob Description Your Career With Cloud Identity Engine, we’re building the foundations of the next inflectionpoint in the security industry by combining our deep expertise in security withthe state of the art in large-scale infrastructure for data processing.We are seeking a Principal Software Engineer to design, develop and delivernext-generation...
-
Sr. Engineer
1 week ago
Santa Clara, United States Tech Mahindra Full timeRole: Obsolescence Engineer Location : Santa Clara CA or Austin TX Type: FTE/Contract $60-70/H - based on experience FTE-$110K-$115K(MAX) Qualifications: •Bachelor's degree in Electrical / Electronics & Communication / Mechanical Engg Key Responsibilities •Conduct obsolescence risk assessment for prompt risk mitigation strategy and implementation to...
-
Senior Component Engineer
2 weeks ago
Santa Clara, United States NVIDIA Full timeSenior Component Engineer page is loaded Senior Component Engineer Apply locations US, CA, Santa Clara time type Full time posted on Posted 20 Days Ago job requisition id JR1978778 We are looking to staff this Component Engineering position that is based in Santa Clara, California at NVIDIA Corporate headquarters. The Senior Component Engineer will have the...
-
Thermal Engineer
4 weeks ago
Santa Clara, United States IT Resource Hunter Full timeThermal Engineer Santa Clara, CA (Onsite)Need bilingual (English and Chinese/Mandarin) Responsibility:1. Early engineering involvement for new project development through NPI to mass production2. Drive day-to-day activities to meet overall project objectives3. Create and maintain project schedules4. Possess strong presentation skills5. Collaborate and...