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Sr Quality Engineer - CAPA Coordinator

Company: Jobleads
Location: Cypress
Posted on: May 3, 2021

Job Description:

*this role can be located in San Francisco or Cypress, CA About iRhythm: iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmia's are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmia's. iRhythm's continuous ambulatory monitoring has already put over 3 million patients and their doctors on a shorter path to what they both need - answers. As the iRhythm CAPA Manager you will be responsible for maintaining a robust global CAPA process across iRhythm. You will serve as an advocate for cross functional collaboration, continuous improvement, and compliance, with the responsibility of driving excellent quality system CAPA process performance globally. This role will work closely with cross-functional CAPA owners to provide training, guidance, and review of CAPA investigations and phases. In this role you will have the opportunity to impact product and process quality and regulatory compliance at iRhythm. In iRhythm's fast growing environment you will have the opportunity to enhance your technical skills and leadership competencies and advance your career. This role supports various U.S. and UK iRhythm sites and may require 15% travel. Responsibilities: Ensure the iRhythm CAPA system is compliant to U.S. and applicable international standards / regulations, including ISO 13485, ISO 14971 and EU MDD/MDR requirements. Chair cross-functional CAPA Board meetings, drive decision making, and follow through on outcomes Work alongside CAPA owners and stakeholders on assessing issue descriptions and ensuring containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks are appropriate, of high quality, and timely. Train and mentor CAPA owners in all required elements and best practices of CAPA, including use of the CAPA tool. Represent CAPA program, system and individual CAPA records during regulatory and internal audits. Maintain the quality and compliance of CAPA system records to ensure audit-readiness for internal and external quality system audits. Produce, analyze, and present trend metrics and reports and establish further actions as needed. Engage in continuous improvement of the CAPA program by identifying opportunities and recommending actions. Required Qualifications: Bachelor's Degree or equivalent quality/regulatory experience Minimum of 5 years of experience in Quality or Regulatory related role. Minimum of 2 years of experience with Corrective Action and Preventative Action activities, within a medical device or equivalent healthcare company. Must have deep understanding of CAPA system and associated regulatory requirements. Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD/MDR Minimum of 2 years of experience participating in regulatory audits in the front room and back room. Strong investigational and problem solving skills Must build rapport across functional teams within the organization and have the ability to work comfortably at all levels within the organization Attention to detail and timeliness are critical Excellent communication (verbal and written) and interpersonal skills required Basic statistical methods including trend analysis What's in it for you: This is a full-time position with competitive compensation package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off. iRhythm also provides additional benefits including 401K (w/ company match), employee stock purchase plan, annual organizational and cultural committee events and more! FLSA Status: Exempt As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records. Are you authorized to work in the United States? * Will you now, or in the future, require sponsorship for an employment visa status (e.g.: H-1B visa status)? If you'll require our company to commence sponsorship for an immigration or work permit case in order to employ you, then you should select "Yes". Otherwise, select "No". * U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at iRhythm are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to: Autism Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS Blind or low vision Cancer Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or hard of hearing Depression or anxiety Diabetes Epilepsy Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome Intellectual disability Missing limbs or partially missing limbs Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS) Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Jobleads, Cypress , Sr Quality Engineer - CAPA Coordinator, Other , Cypress, California

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