Quality Director at Best Buy Health in Boston, Massachusetts

Posted in Other about 16 hours ago.

Job Description:

<div dir="ltr">As a Quality Director you will be responsible for leading, managing and supporting the QA program for the company's Software as a Medical Device (SaMD) and other medical devices (hardware and software components). You will ensure compliance with relevant regulations (ISO 13485, EU MDR, FDA 820, and ROW where applicable) by bringing clarity to an ambiguous environment through building out process, metrics and best practices. Additionally, you will have a team of 7 who, collectively, are located both in the US and the UK - being flexible working across time zones will be crucial to your success. This role is remote, which means you would work virtually from home or another US-based non-Best Buy Health location. What you'll do </div><ul dir="ltr"><li>Lead the QA program responsible for ensuring compliance of the company's SaMD and other medical devices </li><li>Lead the QA team in conducting supplier management, risk assessments, audits, inspections, Complaints, CAPAs, and NCs, and other quality control activities for SaMD and other medical devices, including both hardware and software components. </li><li>Ensure the effective execution of quality control procedures throughout the entire product lifecycle (design, development, manufacturing, distribution, post-market surveillance) </li><li>Oversee the implementation of Supplier Corrective Action (SCA), complaints, corrective and preventive action (CAPA) processes, and Non Conformance Reports </li><li>Develop and maintain a strong quality culture within the organization, fostering employee ownership and commitment to quality. </li><li>Participate in strategic planning and decision-making for the company's medical device development and commercialization efforts. </li></ul><div dir="ltr">Basic qualifications </div><ul dir="ltr"><li>Minimum 8 - 10 years of experience in Software as a medical device (SaMD) and supplier management required </li><li>5 years of experience in leadership roles within quality assurance (QA) required </li><li>Prior experience working with a Quality Management System (QMS) for medical devices which includes software as a medical device (62304), ensuring compliance with ISO 13485:2016 and other relevant standards required </li><li>In-depth knowledge of US (FDA QSR 820), EU (MDR 2017/745, MHRA), and international regulatory requirements for medical devices required </li><li>Experience in managing and conducting complex quality audits, inspections, and investigations required </li></ul><div dir="ltr">Preferred qualifications </div><ul dir="ltr"><li>Bachelor's degree in engineering, science, or a related field preferred </li><li>Certified Quality Engineer (CQE) certification strongly preferred </li></ul><div dir="ltr">What's in it for you We're committed to helping our people thrive at work and at home. We offer generous benefits that address your total well-being and provide support as you need it, especially key moments in your life. Our benefits include: </div><ul dir="ltr"><li>Physical and mental well-being support via Best Buy Health Wellness Program </li><li>Comprehensive benefits including tuition reimbursement, caregiver support, and more </li><li>Generous Best Buy employee discount </li></ul><div dir="ltr"> About us Best Buy Health aims to enrich and save lives through technology and meaningful connections. Our strategy focuses on three main areas: consumer health products that help customers live healthier lives, device-based emergency response services for the active aging population, and virtual care offerings that help to connect patients and physicians. Best Buy Health is an Affirmative Action and Equal Opportunity Employer dedicated to creating an inclusive environment that values the diversity of our employees and does not discriminate against any employee or applicant. We are committed to equal employment opportunity for all applicants and employees, without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, gender identity, genetic information, or any other protected characteristic under applicable law. Learn more about our Affirmative Action Policy Statement <a href="https://sn.bestbuy.com/myhr?id=kb_article&sysparm_article=KB0207591" target="_blank">HERE</a>. Reasonable Accommodation Best Buy Health will make reasonable accommodations for employees and applicants for their religious beliefs and practices, mental or physical disabilities, and pregnancy, childbirth and related conditions. If you need a reasonable accommodation in the application process - to access job postings, to apply for a job, for a job interview, for pre-employment testing or with the onboarding process - please contact Talent Acquisition at talent.acquisition@bestbuy.com. To learn more about, view the "Know Your Rights" poster and Pay Transparency Nondiscrimination Provision <a href="https://sn.bestbuy.com/myhr?id=kb_article&sysparm_article=KB0207598" target="_blank">HERE</a>.</div>PandoLogic. Keywords: Quality Control / Quality Assurance Director, Location: Boston, MA - 02108

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Quality Director at Best Buy Health in Boston, Massachusetts

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