Medical Device Quality Engineer I
2 weeks ago
Who 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, Osteoids software and hardware tools keep dental practices and labs ahead of the curve and allow dentists to competently diagnose any patient scan in 3D. An osteoid is a soft organic element that forms bones in the human body. Just like osteoids in the human body, Osteoid is providing the essential software to dental practice success. Osteoid is a wholly owned dental-focused subsidiary of Anatomage.
www.osteoidinc.com .
About the Role
We are looking for a Quality Engineer or Specialist to join our rapidly expanding team. As a member of our Quality & Regulatory team, youll be responsible for developing and maintaining our quality system for our medical device products. Together as a team, youll help ensure our products are safe and follow global quality standards.
This position is based in Santa Clara, California.
What Youll Do
Help manage, implement, maintain, and improve the quality management system for our medical device products.
Provide support and guidance for introducing and maintaining medical devices in global markets, which may include duties like documentation, auditing support, risk analysis, complaint investigation and handling, CAPA, regulatory submissions, post-market surveillance, and more.
Work together with other departments to provide a holistic approach to product development
Skills and Abilities Required
Strong analytical and problem-solving skills
Previous success working in a fast-paced, dynamic and creative environment
Excellent verbal and written communication skills.
Self-motivated individual who thrives on doing a job well and has the initiative and drive to excel
Ability to effectively prioritize, organize, and perform a variety of concurrent tasks
Team player attitude, eager to be part of an ambitious team
Great interpersonal skills
Qualities We Look For
Experience with Medical Device Software and Hardware
Experience with QMS/eQMS
Knowledge of ISO 13485 / MDSAP
Global regulatory affairs experience (FDA, MDD/CE/MDR, UKCA, etc.)
Document Control experience
Proficiency in computer technology and operations
Ability to work independently and as a team
Demonstrate attention to detail
Minimum Education and Experience Required
Degree in scientific, engineering, or related fields.
2+ years of experience in a quality engineering, quality specialist, quality assurance, or similar role.
ASQ certification preferred
What We Offer
Health, Dental, and Vision care for you and your family
401K savings plan with employer matching
Generous PTO leave and paid holidays
Casual work culture
Gym Stipend
Employee Assistance Plan
Team bonding activities and more
Osteoid is an Equal Employment Opportunity Employer. We do not offer H-1B Sponsorships at this time. Local candidates preferred.
#J-18808-Ljbffr
-
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...
-
Medical Device Quality Engineer I
4 days 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...
-
Medical Device Quality Engineer I
Found in: Resume Library US A2 - 2 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 Quality Engineer
2 days ago
Santa Clara, United States Select Source International Full timeJob Description Job Description Job Title: - Quality Engineer IV Location: - Santa Clara, CA 95054 Duration: - 6 Months of Contract (With Possible Extension) Description / Summary: 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...
-
Quality Engineer
6 days ago
Santa Clara, United States The Fountain Group Full timeJob DescriptionJob DescriptionThis 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...
-
Sr Quality Engineer
6 days ago
Santa Clara, United States Select Source International Full timeJob DescriptionJob DescriptionJob Title: - Quality Engineer IVLocation: - Santa Clara, CA 95054Duration: - 6 Months of Contract (With Possible Extension) Description / Summary: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...
-
Quality Engineer III
Found in: beBee S US - 3 weeks ago
Santa Clara, 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...
-
Quality Engineer III
Found in: beBee jobs US - 3 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...
-
Account Partner
Found in: Jooble US O C2 - 6 days ago
Santa Clara, CA, United States Amazon Full timeHead of Medical Devices, Healthcare and Life Sciences (HCLS), Americas, AMER Partner Management - Bachelor's degree - Experience managing programs across cross functional teams, building processes and coordinating release schedules For almost a decade, AWS has helped medical device organizations increase margins, accelerate innovations, and do more with...
-
Senior Imaging Systems Software Engineer
2 hours ago
Santa Clara, United States DeepSight Technology Full timeJob DescriptionJob DescriptionAre you passionate about advancing medical imaging technology? If so, DeepSight Technology Inc., located in Santa Clara, CA, is seeking a talented full-time Senior Imaging Systems Software Engineer to drive innovation in our ultrasound imaging!As our Senior Imaging Systems Software Engineer, you'll enjoy a competitive salary...
-
Mechanical Engineer
2 weeks ago
Santa Clara, United States Intevac Full timeJob DescriptionJob DescriptionJob Summary:Develop, test, and document designs for vacuum systems, transport mechanisms, and various coating processing stations (PVD), including deposition chambers, substrate heating, cooling, cleaning, etc. Worked with machine shops, pulleys, belts, motors, machined aluminum parts, frames, steel, and pumps.Primary...
-
System Engineer I
1 week ago
Santa Clara, United States PSG Global Solutions Full timeDescription We're looking for a System Engineer I , working in Healthcare Systems and Services industry in 2841 Scott Boulevard, Santa Clara, California, 95050, United States . Job Description: Organizes, conducts, and monitors laboratory experiments utilizing established and published procedures, building technical and theoretical understanding. Assumes...
-
Quality Inspector I
4 days ago
Rancho Santa Margarita, United States Applied Medical Full time____________________________________: Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the...
-
Senior Quality Engineer
7 days ago
Santa Rosa, United States Kelly Science Engineering Technology & Telecom Full timeKelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking a Senior Quality Engineer for a long-term engagement at one of our Global Medical Device Manufacturing clients located in Santa Rosa, CA .Our client is a clinical-stage medical device company advancing transseptal left...
-
R&D Engineer I
2 days ago
Santa Ana, United States TalentBurst Full timePosition: R&D Engineer I , Req#: 6477-1 Location: Irvine, CA (100% onsite) Duration: 12 Months Contract Top Skills: 1 year of professional experience in the medical device field. Design Verification experience, specifically releasing and writing DV plans/reports for medical devices. Job Description: Applies knowledge of technical principles and the client's...
-
Senior Quality Engineer
2 weeks ago
Santa Rosa, United States Kelly Science, Engineering, Technology & Telecom Full timeKelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking a Senior Quality Engineer for a long-term engagement at one of our Global Medical Device Manufacturing clients located in Santa Rosa, CA. Our client is a clinical-stage medical device company advancing transseptal left...
-
Test Technician II
3 days ago
Santa Barbara, United States Arthrex, Inc. Full timeCandidate must be proficient in all requirements of Test Technician I. Support Manufacturing in the daily production testing of camera video systems. Directly responsible for the production FCO (Final Checkout), electrical test process. Capable of te Test Technician, Medical, Technician, Device, Electronics, Mechanical, Healthcare
-
Quality Inspector I
Found in: Resume Library US A2 - 2 weeks ago
Rancho Santa Margarita, California, United States Applied Medical Full time_________________________________________________________________________: Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a...
-
Senior Imaging Systems Software Engineer
Found in: Appcast Linkedin GBL C2 - 2 days ago
Santa Clara, United States Protingent Full timeWHAT WE NEED FROM YOU AS A SENIOR IMAGING SYSTEMS SOFTWARE ENGINEERWe are looking for an engineer with a strong background in ultrasound, signal processing, image optimization, and programming languages such as Python or C++ to shape our new ultrasound imaging platform. As a Senior Imaging Systems Software Engineer, you will work on characterization,...
-
Senior Imaging Systems Software Engineer
Found in: Appcast US C2 - 2 days ago
Santa Clara, United States Protingent Full timeWHAT WE NEED FROM YOU AS A SENIOR IMAGING SYSTEMS SOFTWARE ENGINEERWe are looking for an engineer with a strong background in ultrasound, signal processing, image optimization, and programming languages such as Python or C++ to shape our new ultrasound imaging platform. As a Senior Imaging Systems Software Engineer, you will work on characterization,...