Sr. Quality Engineer

6 months ago

Cypress, United States iRhythm Full time

Boldly innovating to create trusted solutions that detect, predict, and prevent disease.

Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now 

At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.

About This Role

iRhythm Technologies, Inc. is seeking a highly skilled and experienced Senior Quality Engineer to join our vibrant team. This role is for a Risk Management expert, who would be assisting in the development, maintenance and continuous improvement of the global medical device risk management strategies and procedures for iRhythm products and processes. This individual will play a key role in achieving products of the highest quality and maintain regulatory compliance to medical device risk management standards and regulations, including the EU MDR requirements. 

This is a hybrid role and will require an in-office presence 2 days/week in our Cypress, CA location. Relocation assistance is not being offered.

Responsibilities:

Your quality or clinical background and expertise in ISO 14971 will be utilized to strengthen the Organizational understanding and importance of applying proper Risk Management processes and techniques.You will lead Risk Management activities within product development (Design and Use), manufacturing processes (PFMEAs), and the post-market surveillance phase.You will provide quality oversight to project teams in terms of the Risk Management System, including post-market information of similar products’ feedback into the new product development cycle.Your knowledge will be utilized to develop and maintain Post-Market Health Hazard/Risk Evaluations across all products.You will lead activities to maintain a closed-loop Risk Management process that incorporates information obtained from post-market surveillance into new product development, process improvements, and clinical evaluation reports.You will interface with iRhythm’s clinical team, including Medical Directors as necessary, to standardize Risk Management approach across product design, manufacturing, and post-market surveillance processes.You will represent Risk Management processes and documents during internal and external audits.You will keep abreast of emerging regulatory and industry trends regarding risk management and act as the risk coach and trainer within iRhythm.

Required Qualifications:

Bachelor’s Degree in science, engineering, or healthcare related field.Minimum of 5 years of experience in Quality, Regulatory, or Clinical related role.Experience with Risk Management standards such as ISO 14971 and Risk Management tools, methodologies, and processes including use of a variety of accepted methods. Working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDR requirements. Must build rapport across functional teams within the organization and collaborate on risk management activitiesAttention to detail and timeliness are criticalExcellent communication (verbal and written) and interpersonal skills requiredDirect exposure to FDA inspections and Notified Body audits preferredClinical experience or background preferred 

What's In It For You

This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:

emotional health support for you and your loved oneslegal / financial / identity theft/ pet and child referral assistancepaid parental leave, paid holidays, travel assistance for personal trips and PTO

iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of LinkedIn Learning classes and so much more 

  • Senior Quality Engineer

    4 weeks ago

    Cypress, California, United States iRhythm Technologies Full time

    About This RoleiRhythm Technologies is seeking a highly skilled and experienced Senior Quality Engineer to join our quality team during this pivotal phase of our growth journey. As a Senior New Product Introduction (NPI) Quality Engineer, you will hold a critical position within our NPI Quality Engineering group, providing indispensable support across both...

  • Quality Engineer

    2 months ago

    Cypress, United States Johnson Service Group Full time

    JSG is hiring a Quality Engineer - Onsite role for our client in Cypress, CA. Job Duties:  Administer Internal Corrective and Preventative Action Requests (CAR/PAR) Perform Internal Audits as part of  QMS Coordinate outside test lab analysis as needed Assist in Responding to Our Customer’s Supplier Corrective and Preventative Actions Requests to...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Cypress, California, United States iRhythm Technologies Full time

    About This RoleThis is an exciting opportunity to join iRhythm Technologies as a Senior Supplier Quality Engineer. As a key member of our Quality team, you will be responsible for managing our suppliers, ensuring they meet our quality standards, and driving continuous improvements to our Supplier Quality Program.Key ResponsibilitiesManage iRhythm suppliers...

  • Surgical Technologist

    4 weeks ago

    Cypress, Texas, United States Quality Talent Group Full time

    About the JobThe Sr Surgical Technologist position at Quality Talent Group requires a skilled professional to provide support in the operating room, particularly in Labor & Delivery. This role involves working independently, exercising sound judgment, and reporting observations and patient problems to the licensed nurse or surgeon.Key ResponsibilitiesPrepare...

  • Quality Assurance Specialist

    1 month ago

    Cypress, California, United States Johnson Service Group Full time

    Quality Engineer Job DescriptionWe are seeking a highly skilled Quality Engineer to join our team at Johnson Service Group. As a Quality Engineer, you will be responsible for ensuring the quality of our products and services, identifying and implementing process improvements, and maintaining compliance with regulatory requirements.Administer Corrective and...

  • Sr Tax Manager

    6 days ago

    Cypress, United States Yamaha Motor Corporation, USA Full time

    Yamaha Motor Corporation, U.S.A. is a growing and dynamic organization with superb products that includes motorcycles, outboard motors, ATVs, personal watercraft, snowmobiles, boats, power assist bicycles, outdoor power equipment, race kart engines, accessories, apparel, and much more! We are a company of enthusiasts and have passion for our products! Yamaha...

  • Lead Respiratory Care Practitioner

    2 months ago

    Cypress, United States Quality Talent Group Full time

    About the job Lead Respiratory Care Practitioner - Nights - Full-Time At Houston Methodist, the Lead Respiratory Care Practitioner (RCP) position functions in a lead role, for an assigned shift and/or area, performing lead job duties which include projects or specialized responsibilities as a regular part of their normal job responsibilities. In addition to...

  • Sr Surgical Technologist

    2 weeks ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr Surgical Technologist (L&D) position requires proficient knowledge and skills necessary to carry out delegated tasks associated with the safe and efficient operating room support functions and anticipating the needs of the surgeon and nursing staff to support the patient during the vaginal delivery and/or surgical procedure. This...

  • Sr. Anesthesia Technician

    2 weeks ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    3 weeks ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Machinist Sr

    3 weeks ago

    Cypress, United States Dover Corporation Full time

    DOVER PRECISION COMPONENTS: Dover Precision Components 'DPC' ('the Company') is part of Dover Corporation's ('the Parent Company') Pumps and Process solutions segment. DPC holds market leading positions globally and delivers performance-critical solutions across the oil & gas, power generation, marine, industrial, chemical and general processing markets....

  • Sr. Anesthesia Technician

    2 weeks ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    2 weeks ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    4 weeks ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    2 months ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    2 months ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    2 months ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    4 days ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    3 weeks ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...

  • Sr. Anesthesia Technician

    2 months ago

    Cypress, United States Houston Methodist Cypress Hospital Full time

    At Houston Methodist, the Sr. Anesthesia Technician (AT) position is an experienced Tech who provides support to the anesthesia providers and other members of the interprofessional health care team. This position is fully competent regarding anesthesia, all anesthetizing locations, anesthesia supplies, and other related equipment ensuring that assigned...