**_Kelly Science, Engineering, Technology and Telecom_** _a managed solution provider and business unit of Kelly Services, is currently seeking a_ **_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._ 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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 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.