We have other current jobs related to this field that you can find below
-
Medical Device Quality Engineer
4 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 Medical Device Quality Assurance 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...
-
Quality Assurance 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 Medical Device Quality Assurance 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...
-
Quality Assurance Engineer
1 week 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 Medical Device Quality Assurance 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...
-
Sr R/D Engineer-Medical Device-Only W2
2 weeks ago
Santa Rosa, United States Grove Technical Resources, INC Full timeJob Title - Sr R/D Engineer - ExemptJob Location - 3540 Unocal Place, Santa Rosa, California, United States of America, 95403HM's Top Needs:1. Catheter development experience2. Test method development and validation experience3. Proven Root cause investigation experienceServe as a technical expert in the development of engineering solutions for a derivative...
-
Sr R/D Engineer-Medical Device-Only W2
2 weeks ago
Santa Rosa, United States Grove Technical Resources, INC Full timeJob Title - Sr R/D Engineer - ExemptJob Location - 3540 Unocal Place, Santa Rosa, California, United States of America, 95403HM's Top Needs:1. Catheter development experience2. Test method development and validation experience3. Proven Root cause investigation experienceServe as a technical expert in the development of engineering solutions for a derivative...
-
Engineer II
3 months ago
Santa Barbara, United States Arthrex Full timeRequisition ID: 60254 Title: Engineer II - Mechanical - Medical Devices Division: Arthrex, Inc. (US01) Location: INC Santa Barbara CA (ACT) (US17) Salary Range: Salary Minimum: $92,000.00 Salary Maximum: $143,750.00 Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Mechanical...
-
Engineer II
2 months ago
Santa Barbara, United States Arthrex Full timeArthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and...
-
Senior Manufacturing Engineer
4 days ago
Santa Ana, United States ATR International Full timeJob Title: Senior Manufacturing EngineerType: Contract - 2 YearsDay ShiftPay: $63.10 - trying to stay around that rate but can assess based on experienceWe are seeking a Sr Manufacturing Engineer for a very important client.Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production...
-
R&D Engineer II
1 month ago
Santa Rosa, United States Grove Technical Resources, INC Full timeTitle – R&D Engineer II -Medical DevicesLocation – Santa Rosa, CAHM's Top Needs:1.Product development experience2.Quick learner3.Hands-onAdditional NotesDelivery systems Engineer in the R/D Department with ongoing clinical trial. They will be supporting this trial.· Maintain supply of the product for the trials, MDRs and non-conformances, supply...
-
R&D Engineer II
1 month ago
Santa Rosa, United States Grove Technical Resources, INC Full timeTitle – R&D Engineer II -Medical DevicesLocation – Santa Rosa, CAHM's Top Needs:1.Product development experience2.Quick learner3.Hands-onAdditional NotesDelivery systems Engineer in the R/D Department with ongoing clinical trial. They will be supporting this trial.· Maintain supply of the product for the trials, MDRs and non-conformances, supply...
-
R&D Engineer II
3 weeks ago
Santa Rosa, United States GROVE TECHNICAL RESOURCES, INC Full timeTitle - R&D Engineer II -Medical DevicesLocation - Santa Rosa, CAHM's Top Needs:1.Product development experience2.Quick learner3.Hands-onAdditional NotesDelivery systems Engineer in the R/D Department with ongoing clinical trial. They will be supporting this trial. Maintain supply of the product for the trials, MDRs and non-conformances, supply changes Will...
-
Device Services
6 days ago
Santa Clara, United States Apple Full timeSummary The Device Services (DS) Infrastructure team is seeking a results driven and meticulously organized lab engineer. We manage a fleet of thousands of Apple devices used in a centralized, automated test system which is a critical tool used by engineers developing for iOS, watchOS, tvOS, and macOS.This position will provide the opportunity to work with...
-
Senior Hardware Verification/Test Engineer
3 weeks ago
Santa Rosa, United States Evolve Esolutions Full timeJob DescriptionJob DescriptionJob Description for this position. : IEC testing, as required. Resistor temperature testing (protocol, results, reports) Design specs review/approval. Strong communication and interpersonal Skill.(JD below)Experience band : 4-8 yearsRequested start date for project. ASAP ( can start from next week)Job Location: (Santa Rosa)Total...
-
Sr Quality Assurance Engineer
2 months ago
Santa Clara, California, United States Cordis Full timeJob Title: Senior Quality Assurance Engineer at CordisThe Senior Quality Assurance Engineer collaborates with internal departments to efficiently deliver safe and effective medical device designs for manufacturing in accordance with Cordis policies and procedures.Responsibilities:Act as CAPA Coordinator to ensure timely CAPA processes.Manage the training...
-
Quality Engineer
1 week ago
Santa Ana, United States Grove Technical Resources, INC Full timeJob Title - Quality Engineer Job Location - Santa Ana, CaliforniaHM's Top Needs:Experience in Complaint handling, complaint investigation and root cause analysis for Medical DevicesAbility to work cross-functionally and deliver consistent outputs to meet set targets.Strong knowledge of cardiovascular diseases, use of heart valves and...
-
Quality Engineer
1 week ago
Santa Ana, United States Grove Technical Resources, INC Full timeJob Title - Quality Engineer Job Location - Santa Ana, CaliforniaHM's Top Needs:Experience in Complaint handling, complaint investigation and root cause analysis for Medical DevicesAbility to work cross-functionally and deliver consistent outputs to meet set targets.Strong knowledge of cardiovascular diseases, use of heart valves and...
-
Principal Systems Engineer
3 weeks ago
Santa Clara, United States Dawar Consulting, Inc. Full timeJob DescriptionJob DescriptionOur client, a world leader in diagnostics and life sciences, is looking for "Principal Systems Engineer" based out of Santa Clara, CA. Duration: Long-Term Contract (High possibility of extension)Job Summary:The Principal/Senior System Engineer's focus is on improving reliability and robustness of the microfluidics...
-
Sr. Quality Engineer
3 weeks ago
Santa Clara, United States Cirtec Medical Corporation Full timeJob DescriptionJob DescriptionJOB SUMMARYThe Sr. Catheter Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality engineering support to the new product development process, operations/production, and quality...
-
Software Quality Engineer
2 weeks ago
Santa Rosa, United States ALOIS Solutions Full timeJob Title: R&D System Quality Engineer/ Software EngineerLocation: Santa Rosa, CA 95403This is a Contract position on W2 only and only accepting US Citizens. NO C2C or H1BSummary:• You’ll be working as part of a team developing an integrated SW and HW system used for evaluation and testing of complex Electromagnetic Spectrum components and systems. The...
-
Software Quality Engineer
2 weeks ago
Santa Rosa, United States ALOIS Solutions Full timeJob Title: R&D System Quality Engineer/ Software EngineerLocation: Santa Rosa, CA 95403This is a Contract position on W2 only and only accepting US Citizens. NO C2C or H1BSummary:• You’ll be working as part of a team developing an integrated SW and HW system used for evaluation and testing of complex Electromagnetic Spectrum components and systems. The...
![Kelly Science, Engineering, Technology & Telecom](https://media.trabajo.org/img/noimg.jpg)
Medical Device Quality Engineer
1 month ago
Kelly Science, Engineering, Technology and Telecom
a managed solution provider and business unit of Kelly Services, is currently seeking a
Medical Device Quality Assurance 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 atrial appendage (LAA) closure.The growing incidence of atrial fibrillation and medical device developments have rapidly expanded the market.
This role is a full-time, fully benefited position. As a Kelly employee, you will be eligible for our
enhanced benefits, 50% paid Medical & Dental, 401K
, and a variety of other benefits to choose from. You will also be eligible for paid time off,
including holiday, vacation, and sick/personal
time. All Kelly employees in this group receive annual performance reviews.
In this role, you will provide technical leadership on a daily basis by developing, establishing, and maintaining quality engineering methodologies, systems, and practices. This position will also drive product/process improvements with the objective of product safety and high customer satisfaction.
Description of Work
Must be able to interface well with Management, Manufacturing and R&D Engineering, and Supply Chain.
Work with various departments to ensure timely closure of
CAPAs, NCMRs, and Complaints
. Document deficiencies, including
root cause,
corrective and preventive action plans. Ensure action plans are implemented in a timely manner.
Lead and support test method validation plans/protocols and reports.
Assist with risk analysis activities and maintaining up-to-date risk management documents.
Establish Quality Inspection Plans for the release of components, assemblies, and finished devices. Conduct quality inspections as needed.
Support Manufacturing with equipment qualifications (IQ/OQ/PQ), process validations and process improvements. Includes the use of various statistical techniques and quality tools.
Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
Evaluate significant product and/or process changes and enhancements that reduce defects, improve yields, and lower product cost.
Support quality management programs such as supplier selection and certification. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
Lead supplier audits and works with suppliers to resolve audit findings and/or nonconformances.
Perform internal audits as needed.
Responsible for quality engineering review of Document Change Orders.
Devise and review specifications for products or processes.
Set requirements for raw materials or intermediate products for suppliers and monitor their compliance.
Ensure adherence to regulatory requirements, and health and safety guidelines.
Supervise inspectors, technicians and other staff and provide guidance and feedback.
Oversee all product development procedures to identify deviations from quality standards.
Inspect final output and compare properties to requirements.
Manage the sterilization program.
Required Skills & Experience
Minimum of a BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree.
4+ years of relevant experience in medical devices
.
Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.
Ability to deliver, meet deadlines and be results-oriented.
Detail-oriented, thorough, and observant.
Excellent communication skills (oral, written, presentation) at different organizational levels.
Experience with
root cause analysis
tools and methods.
Investigations, NCMR, CAPA and complaints.
Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971.
Important information:
Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.
#J-18808-Ljbffr