Medical Device Quality Engineer

2 weeks ago

Santa Rosa, United States Kelly Services Full time

Kelly Science, Engineering, Technology and Telecom, a managed solution provider and business unit of Kelly Services, is seeking a Quality Engineer with Class III Medical Device experience for an exciting job opportunity with one of our Global Medical Device Manufacturing clients in Santa Rosa, CA.
 
Our client is a medical device company working with atrial fibrillation and medical device developments. 

In this role, you will provide technical leadership daily by developing, establishing, and maintaining quality engineering methodologies, systems, and practices. Quality assurance in class III medical devices and implant devices.  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 promptly.
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.

Required Skills & Experience


Minimum of a BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, or equivalent degree.
4+ years of quality assurance experience in class III medical devices and implant devices preferred
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.





 




As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Engineering/Technology – Project Services? Looking to work with leading project management organizations at top companies around the world? That’s where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world’s most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That’s just good planning.






About Kelly Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

  • Medical Device Quality Engineer

    1 month ago

    Santa Rosa, United States Kelly Science, Engineering, Technology & Telecom Full time

    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...

  • Medical Device-Quality Engineer-- W2

    1 week ago

    Santa Ana, United States Grove Technical Resources, INC Full time

    Job Title - Quality Engineer I Job Location -Santa Ana, California HM's Top Needs: Experience in Complaint handling, complaint investigation and root cause analysis for Medical Devices Ability to work cross-functionally and deliver consistent outputs to meet set targets. Strong knowledge of cardiovascular diseases, use of heart valves and catheters ...

  • Quality Assurance Engineer

    4 weeks ago

    Santa Rosa, United States Kelly Science, Engineering, Technology & Telecom Full time

    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...

  • Quality Assurance Engineer

    4 weeks ago

    Santa Rosa, United States Kelly Science, Engineering, Technology & Telecom Full time

    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...

  • Sr Quality Engineer

    4 days ago

    Santa Rosa, United States Kelly Services Full time

    Kelly 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...

  •  Sr R/D Engineer-Medical Device-Only W2

    4 weeks ago

    Santa Rosa, United States Grove Technical Resources, INC Full time

    Job 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

    4 weeks ago

    Santa Rosa, United States Grove Technical Resources, INC Full time

    Job 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 time

    Requisition 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...

  • Hardware Test Engineer

    2 weeks ago

    Santa Clara, United States Pioneer Data Systems Full time

    Our client, a world-leading Pharmaceutical Company in Santa Clara, CA is currently looking for a Hardware Test Engineer to join their expanding team. Position Details: Job Title: Hardware Test Engineer / Medical Devices Duration: 4 months contract, extendable up to 24 months Location: Santa Clara, CA Note: The client has the right-to-hire you as a...

  • Hardware Test Engineer

    2 weeks ago

    Santa Clara, United States Pioneer Data Systems Full time

    Our client, a world-leading Pharmaceutical Company in Santa Clara, CA is currently looking for a Hardware Test Engineer to join their expanding team. Position Details: Job Title: Hardware Test Engineer / Medical Devices Duration: 4 months contract, extendable up to 24 months Location: Santa Clara, CA Note: The client has the right-to-hire you as a permanent...

  • Engineer II

    3 months ago

    Santa Barbara, United States Arthrex Full time

    Arthrex, 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...

  • Hardware Test Engineer

    1 week ago

    Santa Clara, United States Pioneer Data Systems Full time

    Our client, a world-leading Pharmaceutical Company in Santa Clara, CA is currently looking for a Hardware Test Engineer to join their expanding team. Position Details: Job Title: Hardware Test Engineer / Medical Devices Duration: 4 months contract,...

  • Senior Manufacturing Engineer

    2 weeks ago

    Santa Ana, United States ATR International Full time

    Job 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...

  • Senior Manufacturing Engineer

    3 weeks ago

    Santa Ana, United States ATR International Full time

    Job 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...

  • Hardware Verification Engineer

    1 week ago

    Santa Rosa, United States VeeAR Projects Inc. Full time

    Position: Senior Hardware Verification/Test EngineerLocation: Santa Rosa, CADuration: 12 MonthsJob Description: The Senior Hardware Verification/Test Engineer will play a critical role as a part of the verification and test team. He will work on IEC testing and other hardware testing, temperature testing (protocol, results, reports), Design specs...

  • Hardware Verification Engineer

    1 week ago

    Santa Rosa, United States VeeAR Projects Inc. Full time

    Position: Senior Hardware Verification/Test EngineerLocation: Santa Rosa, CADuration: 12 MonthsJob Description: The Senior Hardware Verification/Test Engineer will play a critical role as a part of the verification and test team. He will work on IEC testing and other hardware testing, temperature testing (protocol, results, reports), Design specs...

  • Project Manager

    3 days ago

    Santa Clara, United States Cambridge Recruiters Full time

    Fast-Growing Cardiovascular Medical Device Company is looking for a Project Manager/Senior PM to help support Catheter product development and manufacturing projects. Ideal Candidate will have an Engineering Background, and 3-5 years engineering (R&D or Mfg) experience and 2-4+ years dedicated Project Management experience.Job Focus: Planning, coordinating,...

  • Project Manager

    3 days ago

    Santa Clara, United States Cambridge Recruiters Full time

    Fast-Growing Cardiovascular Medical Device Company is looking for a Project Manager/Senior PM to help support Catheter product development and manufacturing projects. Ideal Candidate will have an Engineering Background, and 3-5 years engineering (R&D or Mfg) experience and 2-4+ years dedicated Project Management experience.Job Focus: Planning, coordinating,...

  • Senior Hardware Verification and Validation Engineer

    3 days ago

    Santa Rosa, California, United States EVOLVE ESOLUTIONS LLC Full time

    Job SummaryEVOLVE ESOLUTIONS LLC is seeking a highly skilled Senior Hardware Verification and Validation Engineer to join our team. As a key member of our engineering team, you will be responsible for ensuring the quality and reliability of our medical device components.Key ResponsibilitiesConduct thorough hardware functional verification and testing to...

  • Senior Device Design Engineer

    1 day ago

    Santa Clara, California, United States Charlesbrownrecruitment Full time

    Job Summary:We are seeking a highly skilled Senior Device Design Engineer to join our team at Charlesbrownrecruitment. As a Senior Device Design Engineer, you will be responsible for creating innovative MOSFET designs that meet our company's high standards.Key Responsibilities:Design and Development: You will be responsible for designing and developing...