Quality Assurance Specialist jobs at Berkshire Sterile Manufacturing

The ECMO Specialist is enrolled and actively participating in the department's ECMO Training Program. This role is responsible for developing and maintaining the skills necessary to proficiently and safely establish, manage, and control extracorporeal membrane oxygenation (ECMO) technology and assist with associated procedures in acutely ill patients of all ages in critical care settings. The specialist will learn to troubleshoot devices and associated equipment under the supervision of experienced ECMO personnel, provide ongoing care through surveillance of clinical and physiologic parameters, adjust ECLS devices as needed, administer and document blood products and medications in accordance with hospital standards, provide airway and ventilator management, and perform the full scope of practice of a Respiratory Therapist II. Schedule: 36 hours per week, rotating day/night shifts, every third weekend. **This position is eligible for full time benefits $20,000 sign-on bonus (not eligible for internal candidates and not eligible for former BCH employees who worked here in the past 2 years) Key Responsibilities: Assemble, prepare, and maintain extracorporeal circuits and associated equipment with assistance. Assist in priming extracorporeal circuits and preparing systems for clinical application. Assist with cannulation procedures. Assist in establishing extracorporeal support; monitor patient response, provide routine assessments, circuit evaluations, patient monitoring, and anticoagulation management. Assist with ECMO circuit interventions, weaning procedures, and transports. Administer blood products per hospital standards. Interact and communicate with caregivers, nursing, surgical and medical teams, patients, and family members. Maintain relevant clinical documentation in the patient's electronic health record. Participate in professional development, simulation, and continuing education. Attend ECMO Team meetings and M&M conferences on a regular basis. Minimum Qualifications Education: Required: Associate's Degree in Respiratory Therapy Preferred: Bachelor's Degree Experience: Required: A minimum of one year of experience as a BCH Respiratory Therapist with eligibility for promotion to RT II, or one year of external ECMO experience Preferred: None specified Licensure / Certifications: Required: Current Massachusetts license as a Respiratory Therapist Required: Current credential by the National Board of Respiratory Care as a Registered Respiratory Therapist (RRT); Neonatal Pediatric Specialist (NPS) credential must be obtained within 6 months of entry into the role Preferred: None specified The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Monday, Tuesday, Thursday, Friday; 6:30 am - 5:00 pm Job Summary Reporting to the Clinical Manager of Ultrasound, the Quality Assurance (QA) Specialist facilitates the US QA program and provides appropriate education to the staff which includes assessing, planning, implementing, and evaluating both orientation and continuing education programs to enhance the quality of patient care services. The US Quality Assurance Specialist oversees the US students including their clinical requirements, completing required clinical paperwork (competencies, evaluations, timecards etc.), and is the point of contact for the clinical instructors from each program. The US Quality Assurance Specialist must possess an advanced knowledge of US, the associated imaging techniques, and exercise discretion and judgment optimizing imaging for each exam. Collaborates with staff, radiologists, and department leadership to ensure exam protocols, patient care processes and image quality are optimized. In conjunction with the Clinical Manager and Assistant Clinical Director (ACD), assists with third party accreditation processes, including but not limited to, The Joint Commission (TJC), Department of Public Health (DPH), Centers for Medicare/Medicaid Services (CMS). Collaborates with department leadership and other educators to develop, implement, and evaluate learning opportunities. The incumbent must have proven problem-solving skills, to be able to assist and provide leadership and training for the students and sonographers. Must be an active participant in departmental initiatives. The incumbent needs to effectively communicate with students, peers, physicians, and patients to ensure safety and quality of imaging. The incumbent may be required to rotate among main campus and community Radiology locations associated with Brigham and Women's Hospital as needed. Qualifications PRINCIPAL DUTIES AND RESPONSIBILITIES: 1. Collaborates with the ACD for accreditation and maintains quality assurance to meet third party agencies, including but not limited to TJC, DPH, CMS 2. Collaborates with staff, radiologists, and department leadership to ensure exam protocols, patient care processes, and image quality are optimized. 3. Functions as a scanning sonographer to maintain optimal direct patient care skills as well as maintain imaging skills. Performs high quality exams, has an in-depth knowledge of anatomy and physiology can operate and utilize all types of ultrasound related equipment and supplies. 4. Assists in the orientation of new employees and formally and informally instructs technologists and residents. 5. Works with ultrasound management team with assessing sonographers through the competency program for new hires, new trainings, and for annual competencies 6. Coordinates training for all staff (technologists, students, etc.) in the use of general US applications and special imaging applications (contrast, elastography, 3D, etc.) and research imaging 7. Instructs the ultrasound students within the clinical setting on all aspects of patient care. This includes but is not limited to imaging, professionalism, safety techniques, empathetic listening, and all other attributes for a diagnostic exam and positive patient experience. Elicit feedback from the staff and uses that to further develop the students. Coordinate student trainings and evaluates students according to competencies outlined by the Medical Sonography Programs. 8. Assists with all quality assurance procedures that are necessary for the department. This includes and is not limited to technical feedback, annual competencies, and prepping team for regulatory visits. 9. The QA specialist will develop training and lead the education process for staff technologists and students to improve individual and department-wide performance, based on information coming through the technical feedback program. 10. Acts as a liaison between the Medical Sonography Programs, Department of Radiology and Hospital Divisions. Addresses any issues that may arise. 11. Responsible for all clinical documentation that the Medical Sonography Programs require. 12. Performs all staff sonographer duties as required. 13. Performs other duties as assigned or required. QUALIFICATIONS 1. Graduate of an accredited school of Diagnostic Medical Sonography and/or Imaging Program with 3-5 years of experience as an ultrasound technologist. 2. Must meet the requirements and successfully complete the ARDMS certification (American Registry of Diagnostic Medical Sonographers) and/or ARRT (S) (American Registry of Radiologic Technologists) and/or equivalent. 3. Must become registered in all the institution's accredited specialties: first or second specialty must be completed within one year of start of employment. Additional specialty within second year of employment. 4. Associate's Degree required. Bachelor's Degree preferred. Will accept 15 years of experience in lieu of Associate degree. Additional Job Details (if applicable) Remote Type Onsite Work Location 45 Francis Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $37.55 - $55.48/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Flexible hours 36-40/week Reporting to the MRI Quality Assurance Manager, the MRI Quality Assurance specialist will assist with the MRI Quality Assurance program by collecting data, implementing new protocols and provide appropriate education to the staff. Assist in facilitating programs are based on the principle of delivering care appropriate to all ages of the patients served in the department. Collaborates with the MRI Quality Manager, staff and radiologists to ensure exam protocols, patient care processes and image quality are optimized. * Demonstrates proficiency all MRI exams including Vascular and Chest imaging, MRI imaging equipment, techniques, and procedures for each vendor and software platforms. * Interfaces with technologists from all MRI imaging sites including but not limited to MGH Main Campus, Chelsea, Waltham and Assembly Row. Job Summary Summary Responsible for facilitating a comprehensive quality improvement program within the radiology department. Responsible for facilitating the modality quality assurance program across the MGB enterprise. Aids in developing, assessing, implementing, and monitoring all image quality to ensure consistent, standardized, high-quality imaging is delivered. Assists in educating staff technologists on modality imaging technology, exam protocols and procedures. Recognizes and implements actions related to quality concerns and performance. Does this position require Patient Care? Yes Essential Functions * Provide data consultation and staff support to clinical, operational process improvement individuals, patient safety individuals, etc. Perform imaging as needed. Assist in oversight of modality quality control procedures, and accreditation of applicable equipment per regulatory guidelines. * Collect data, implement new protocols, provide education to staff in efforts to improve quality within the department. Collaborates with site modality operations and vendors to support application training to ensure consistency of imaging and staff messaging. * Collaborate with leadership, staff, and radiologists to ensure exam protocols, patient care processes, and image quality are optimized. Critical thinking and problem-solving skills to review systems, identify quality issues, and propose solutions to correct quality errors. * Collects and analyzes quantitative and qualitative statistical data and work with vendors to resolve technical problems. Posses a basic understanding of DICOM, Networks, and Image distribution * Function as technologist to maintain optimal direct patient care skills and imaging skills * Provides radiation protection where applicable, and patient safety practices in accordance with prescribed safety standards; records digital images as directed for radiologist interpretation * Ability to adapt to multiple work environments and flexibility to support multiple locations across the enterprise Qualifications Education Associate's Degree Health Science required Can this role accept experience in lieu of a degree? No Licenses and Credentials Basic Life Support [BLS Certification] American Registry of Radiologic Technologists (ARRT) preferred Magnetic Resonance Imaging [R.T.(MR)(ARRT)] Experience MRI Technologist experience with multiple patient populations 5-7 years required quality experience 2-3 years preferred Knowledge, Skills and Abilities * Good communication skills. * Ability to effectively evaluate and problem solve. * Ability to work independently. * Ability to guide, teach, and motivate others. * Good business acumen and analytical skills. Additional Job Details (if applicable) Physical RequirementsStanding Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 175 Cambridge Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $37.55 - $55.48/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Newark, DE, United States Marlborough, MA, United States Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a **Clinical QA Specialist** to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you'll collaborate with cross-functional teams, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting. If you thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare innovation. **Knowledge:** + Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management. + Strong knowledge of medical procedures and the expected and potential outcomes related to Hologic's product portfolio. + Familiarity with post-market surveillance requirements, adverse event reporting, and health risk assessments. + Awareness of regulatory reporting processes, including MedWatch reports, notified body communications, and external notifications. **Skills:** + Proven ability to independently collect, analyze, and assess information associated with adverse events and determine appropriate next steps. + Effective communication skills to interact with internal teams, sales personnel, customers, patients, and regulatory agencies. + Strong organizational skills to ensure timely documentation, reporting, and follow-up of adverse events and regulatory submissions. + Analytical skills to support and lead investigations, including CAPAs, nonconformances, and other quality system processes. + Experience in developing metrics and quality reports related to reportable events and identifying potential excursions. + Ability to innovate and improve processes to enhance efficiency and compliance with post-market surveillance requirements. + Proficient in leading or participating in internal and external audits, inspections, and assessments. **Behaviors:** + Proactive and detail-oriented, ensuring compliance with regulatory requirements and internal procedures. + Collaborative and team-oriented, fostering strong relationships across functions to support investigations and reporting activities. + Customer-focused, ensuring communications and responses are timely, accurate, and aligned with patient safety goals. + Resilient and adaptable, thriving in a fast-paced and evolving environment. + Problem-solving mindset, with a commitment to driving resolution and continuous improvement in quality processes. **Experience:** + Bachelor's degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or a related field. Risk Managers will also be considered. + **5+ years** of experience in a similar role, preferably within the medical device or healthcare industry. + Hands-on experience with adverse event reporting, regulatory communications, and health risk assessments. + Proven track record in supporting or leading CAPAs, nonconformances, and quality investigations. **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $83,000 - $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. **Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.** \#LI-NT1

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Summary Responsible for building, providing, coordinating, and, facilitating comprehensive training and education on the use, maintenance, and troubleshooting of biomedical equipment to BME technical staff. Does this position require Patient Care? No Essential Functions * Develop, deliver, coordinate, and facilitate training programs on the use and maintenance of biomedical equipment, including but not limited to diagnostic, therapeutic, and monitoring devices. * Develop and update training materials, user guides, and standard operating procedures (SOPs) for various biomedical devices and technologies. Ensure training programs are aligned with the latest industry standards, safety regulations, and healthcare protocols. * Provide and facilitate practical, hands-on training sessions, demonstrating how to properly set up, operate, and troubleshoot biomedical equipment. Ensure participants achieve competency in equipment use to enhance patient outcomes. * Stays up to date on new technologies, product updates, and advancements in biomedical engineering. * Ensure that all training content adheres to healthcare regulations, safety standards, and compliance guidelines (e.g., FDA, OSHA). * Evaluate the effectiveness of training programs through assessments, feedback, and observation. Identify areas for improvement and adjust training programs to ensure participants meet required proficiency levels. * Work closely with biomedical engineering teams, medical device manufacturers, and technical staff to ensure smooth integration of biomedical equipment into healthcare operations. Qualifications Education Bachelor's Degree Biomedical Engineering required or Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Experience in biomedical equipment or other closely related role 3-5 years required and Experience in training, staff development, or other related role 1-2 years preferred Knowledge, Skills and Abilities * Strong technical understanding of biomedical equipment, such as diagnostics, patient monitoring, and therapeutic devices. * Excellent communication and presentation skills, with the ability to convey complex technical concepts to non-technical audiences. * Proficiency in Microsoft Office Suite (PowerPoint, Word) and familiarity with training software or learning management systems (LMS). * Problem-solving skills with an ability to troubleshoot and resolve technical issues in real time during training sessions. Additional Job Details (if applicable) Physical Requirements * Standing Frequently (34-66%) * Walking Frequently (34-66%) * Sitting Occasionally (3-33%) * Lifting Frequently (34-66%) * Carrying Frequently (34-66%) * Pushing Occasionally (3-33%) * Pulling Occasionally (3-33%) * Climbing Rarely (Less than 2%) * Balancing Frequently (34-66%) * Stooping Occasionally (3-33%) * Kneeling Occasionally (3-33%) * Crouching Occasionally (3-33%) * Crawling Rarely (Less than 2%) * Reaching Frequently (34-66%) * Gross Manipulation (Handling) Frequently (34-66%) * Fine Manipulation (Fingering) Frequently (34-66%) * Feeling Constantly (67-100%) * Foot Use Rarely (Less than 2%) * Vision - Far Constantly (67-100%) * Vision - Near Constantly (67-100%) * Talking Constantly (67-100%) * Hearing Constantly (67-100%) Remote Type Hybrid Work Location 100 Blossom Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $92,102.40 - $134,056.00/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous evolution of WHOOP's regulatory and quality frameworks as we expand deeper into regulated digital health and medical-grade product capabilities. You will also play a critical role in strengthening WHOOP's design quality discipline, ensuring robust design controls, risk management, and design quality practices. You will shape the regulatory pathway for our next generation of health features, ensure compliance across global markets, and build systems that enable WHOOP to scale medical device development responsibly and efficiently. This role is ideal for a seasoned RA/QA leader who thrives in fast-paced, cross-functional environments and is motivated by the opportunity to help define the future of WHOOP as a health technology company. QUALIFICATIONS: * Lead regulatory strategy for WHOOP's health features and regulated products from development through approval and lifecycle management. * Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment. * Serve as WHOOP's primary liaison with regulatory agencies and notified bodies. * Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle. * Oversee WHOOP's Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks. * Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes. * Lead internal and external audit readiness, including FDA inspections and notified body audits. * Manage post-market surveillance and adverse event reporting. * Review marketing and promotional materials for regulated and general wellness features to ensure compliance. * Build, manage, and mentor a high-performing team. * Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities. RESPONSIBILITIES: * Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred. * 8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields. * Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals. * Demonstrated success building or overseeing a Quality Management System, including experience with external audits. * Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards. * Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software. * Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals. * Working knowledge of privacy and data regulations such as HIPAA and GDPR. * Exceptional communication, leadership, and stakeholder management skills. * Ability to thrive in a fast-paced, high-growth environment with evolving priorities. * Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways. It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $220,000-$245,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements. Learn more about WHOOP.

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous evolution of WHOOP's regulatory and quality frameworks as we expand deeper into regulated digital health and medical-grade product capabilities. You will also play a critical role in strengthening WHOOP's design quality discipline, ensuring robust design controls, risk management, and design quality practices. You will shape the regulatory pathway for our next generation of health features, ensure compliance across global markets, and build systems that enable WHOOP to scale medical device development responsibly and efficiently. This role is ideal for a seasoned RA/QA leader who thrives in fast-paced, cross-functional environments and is motivated by the opportunity to help define the future of WHOOP as a health technology company.QUALIFICATIONS: Lead regulatory strategy for WHOOP's health features and regulated products from development through approval and lifecycle management. Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment. Serve as WHOOP's primary liaison with regulatory agencies and notified bodies. Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle. Oversee WHOOP's Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks. Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes. Lead internal and external audit readiness, including FDA inspections and notified body audits. Manage post-market surveillance and adverse event reporting. Review marketing and promotional materials for regulated and general wellness features to ensure compliance. Build, manage, and mentor a high-performing team. Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities. RESPONSIBILITIES: Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred. 8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields. Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals. Demonstrated success building or overseeing a Quality Management System, including experience with external audits. Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards. Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software. Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals. Working knowledge of privacy and data regulations such as HIPAA and GDPR. Exceptional communication, leadership, and stakeholder management skills. Ability to thrive in a fast-paced, high-growth environment with evolving priorities. Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways. It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $220,000-$245,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements. Learn more about WHOOP .

Description & Requirements We are seeking a detail-oriented Product Documentation Specialist to create, maintain, and improve internal documentation that supports our teams and operations across US Services. The ideal candidate has strong writing skills, works collaboratively with internal and external stakeholders, and contributes to process improvements through clear, accurate documentation. NOTE: This position focuses on operational and process documentation, not technical or engineering documentation. Why Maximus? - Work/Life Balance Support - Flexibility tailored to your needs! - • Competitive Compensation - Bonuses based on performance included! - • Comprehensive Insurance Coverage - Choose from various plans, including Medical, Dental, Vision, Prescription, and partially funded HSA. Additionally, enjoy Life insurance benefits and discounts on Auto, Home, Renter's, and Pet insurance. - • Future Planning - Prepare for retirement with our 401K Retirement Savings plan and Company Matching. - •Unlimited Time Off Package - Enjoy UTO, Holidays, and extended sick leave, along with Short and Long Term Disability coverage. - • Holistic Wellness Support - Access resources for physical, emotional, and financial wellness through our Employee Assistance Program (EAP). - • Recognition Platform - Acknowledge and appreciate outstanding employee contributions. - • Tuition Reimbursement - Invest in your ongoing education and development. - • Employee Perks and Discounts - Additional benefits and discounts exclusively for employees. - • Maximus Wellness Program and Resources - Access a range of wellness programs and resources tailored to your needs. - • Professional Development Opportunities-Participate in training programs, workshops, and conferences. - •Licensures and Certifications-Maximus assumes the expenses associated with renewing licenses and certifications for its employees. Essential Duties and Responsibilities: - Collaborate with internal departments on a regular basis to understand business requirements and needs, participate in working sessions and acquire feedback on documentation. - Perform strategic and ad-hoc data work in support of Product Managers and Product Owners - Analyze and manage moderately complex business process flows and updates to system process flows and requirements. - Create and maintain technical documentation / product development & customer education materials - Create and maintain internal documentation for the Connection Point team included but not limited to job aids and on-boarding materials. - Work with Product Managers, Product Owners and Product Analysts to ensure accurate documentation is maintained. - Oversee multiple forms of documentation audits on existing documentation in SharePoint and Confluence. - Manage and maintain process improvements. This includes but is not limited to collaboration with PM's, PO's and PAs and in some cases other Connection Point departments. - Create, update, and maintain internal and documentation, including process guides, work instructions, and training materials. - Collaborate with internal and external stakeholders to gather requirements and ensure documentation accurately reflects processes and procedures. - Review and improve existing documentation to enhance clarity, usability, and compliance with standards. - Support process improvement initiatives by documenting changes, workflows, and system updates. - Utilize document management systems and Microsoft Office tools to organize and distribute documentation effectively. Minimum Requirements - Bachelor's Degree or equivalent experience and 3+ Years. - Preferred SAFe Agile Certification(s). - Preferred Jira/Confluence experience. - Preferred learning development / documentation experience. - Preferred technical writing experience. - Bachelor's degree in a related field, or an equivalent combination of education and experience. - 3 years' relevant experience with documentation and supporting process improvement initiatives. - Strong attention to detail and organizational skills. - Excellent written communication skills with the ability to create clear, concise, and accurate documentation. - Experience working collaboratively with internal stakeholders to gather information and develop documentation. - Familiarity with document management tools and Microsoft Office (Word, Excel, PowerPoint, SharePoint). - Ability to manage multiple documentation projects simultaneously and meet deadlines. Preferred Requirements - Previous experience in product documentation, writing, or business support role. - Knowledge of process improvement methodologies Home Office Requirements - Maximus provides company-issued computer equipment and cell phone - Reliable high-speed internet service * Minimum 20 Mpbs download speeds/50 Mpbs for shared internet connectivity * Minimum 5 Mpbs upload speeds - Private and secure workspace #ClinicalServices #LI-Remote EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 68,000.00 Maximum Salary $ 75,000.00

Job Description Responsibilities Job Title: Quality Assurance Specialist - US Reports to: Head of Quality & Regulatory FLSA Status: Exempt The Quality Assurance Principal is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Quality Assurance Principal will be responsible for collaborating cross-functionally to support and guide product development. The Quality Assurance Principal will work cross-functionally and within the team to support the Quality processes, such as QMS training, complaint and CAPA management. Essential Duties and Responsibilities As the Quality Assurance Principal, this position will: Actively engage cross-functionally within the organization, such as with the Engineering, Clinical and Marketing teams, to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes. Act as the Quality lead for design changes to existing DeepHealth products, including non-medical devices, to ensure compliance with the applicable standards and guidances. Guide junior Quality Assurance team members to ensure consistent implementation of Quality processes, including design control and risk management. Take ownership of product specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency. Work cross-functionally to integrate products as a result of corporate and/or product acquisitions. Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations. Participate in the development of junior staff, as requested Collect/monitor quality metrics in support of Management Review PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time. Minimum Qualifications, Education and Experience Bachelor's degree in relevant field (or equivalent experience, i.e. Associate's degree with 5 years of experience). Minimum of -10 working in a regulated industry (FDA and Software as a Medical Device preferred). Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred. Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required. Participation in regulatory audits a plus Excellent written and oral communication skills Physical Demands This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation. Working Environment Remote. This position requires domestic / international travel up to 15%. ACCOMMODATIONS Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes! As a Principal Clinical Quality Assurance Specialist, you'll play a pivotal role in ensuring our cardiovascular imaging software is developed with the highest standards of safety, reliability, and clinical precision. You'll lead current product monthly releases, shape testing design and strategies, and guide other CQA members in upholding excellence, compliance, and innovation at every step. Drawing on your expertise in medical imaging and software testing, you'll help bring groundbreaking cardiovascular imaging software to life, advancing care for clinicians and their patients. If you're driven by quality, collaboration, and the chance to pioneer the future of cardiovascular diagnostics, we want you on our team! The ideal candidate will have: 6+ years experience in clinical software quality assurance or medical device testing, with proven success in developing and executing large-scale test strategies and driving process improvements within a regulated industry. Demonstrated ability to guide cross-functional teams, manage multiple complex projects, and make risk-based decisions to ensure high-quality outcomes in a fast-paced startup environment. Strong mentoring and leadership skills, with a track record of supporting professional development and technical growth of team members. Excellent communication, collaboration, and decision-making skills, capable of influencing stakeholders across departments and organizational levels. Familiarity with medical imaging (CTA), AI-enabled clinical software, or cardiovascular diagnostics is strongly preferred. Solid understanding of regulatory standards (e.g., FDA, ISO 13485, IEC 62304) and their application to clinical software testing and quality processes. Advanced degree or equivalent work experience in Biomedical Engineering, Computer Science, Bioengineering, Radiology Technology, or a closely related technical field. Work Location: This is a role based out of our office in Boston, MA. Our team is hybrid and has a preference for local candidates or those located in eastern time zones in the continental U.S. Salary Range: The anticipated base salary range for this position at Elucid is $120,000 - $150,000. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description. ---------------------------------------------------- At Elucid, we believe the best work happens in a flexible hybrid environment. Boston-area employees are encouraged to work from the office on Mondays and Wednesdays, with the option to come in additional days if they prefer. Fully remote employees outside the Boston area come in as needed. We are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability. We understand that self-doubt can sometimes prevent great candidates from applying. If you believe you can make an impact at Elucid, even if you don't meet every qualification, we encourage you to apply!

We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes! As a Principal Clinical Quality Assurance Specialist, you'll play a pivotal role in ensuring our cardiovascular imaging software is developed with the highest standards of safety, reliability, and clinical precision. You'll lead current product monthly releases, shape testing design and strategies, and guide other CQA members in upholding excellence, compliance, and innovation at every step. Drawing on your expertise in medical imaging and software testing, you'll help bring groundbreaking cardiovascular imaging software to life, advancing care for clinicians and their patients. If you're driven by quality, collaboration, and the chance to pioneer the future of cardiovascular diagnostics, we want you on our team! The ideal candidate will have: 6+ years experience in clinical software quality assurance or medical device testing, with proven success in developing and executing large-scale test strategies and driving process improvements within a regulated industry. Demonstrated ability to guide cross-functional teams, manage multiple complex projects, and make risk-based decisions to ensure high-quality outcomes in a fast-paced startup environment. Strong mentoring and leadership skills, with a track record of supporting professional development and technical growth of team members. Excellent communication, collaboration, and decision-making skills, capable of influencing stakeholders across departments and organizational levels. Familiarity with medical imaging (CTA), AI-enabled clinical software, or cardiovascular diagnostics is strongly preferred. Solid understanding of regulatory standards (e.g., FDA, ISO 13485, IEC 62304) and their application to clinical software testing and quality processes. Advanced degree or equivalent work experience in Biomedical Engineering, Computer Science, Bioengineering, Radiology Technology, or a closely related technical field. Work Location: This is a role based out of our office in Boston, MA. Our team is hybrid and has a preference for local candidates or those located in eastern time zones in the continental U.S. Salary Range: The anticipated base salary range for this position at Elucid is $120,000 - $150,000. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description. ---------------------------------------------------- At Elucid, we believe the best work happens in a flexible hybrid environment. Boston-area employees are encouraged to work from the office on Mondays and Wednesdays, with the option to come in additional days if they prefer. Fully remote employees outside the Boston area come in as needed. We are an equal opportunity employer and value diversity at Elucid. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability. We understand that self-doubt can sometimes prevent great candidates from applying. If you believe you can make an impact at Elucid, even if you don't meet every qualification, we encourage you to apply! Powered by JazzHR 7X1nn7j54v

Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Flexible hours 36-40/week Reporting to the MRI Quality Assurance Manager, the MRI Quality Assurance specialist will assist with the MRI Quality Assurance program by collecting data, implementing new protocols and provide appropriate education to the staff. Assist in facilitating programs are based on the principle of delivering care appropriate to all ages of the patients served in the department. Collaborates with the MRI Quality Manager, staff and radiologists to ensure exam protocols, patient care processes and image quality are optimized. - Demonstrates proficiency all MRI exams including Vascular and Chest imaging, MRI imaging equipment, techniques, and procedures for each vendor and software platforms. -Interfaces with technologists from all MRI imaging sites including but not limited to MGH Main Campus, Chelsea, Waltham and Assembly Row. Job Summary Summary Responsible for facilitating a comprehensive quality improvement program within the radiology department. Responsible for facilitating the modality quality assurance program across the MGB enterprise. Aids in developing, assessing, implementing, and monitoring all image quality to ensure consistent, standardized, high-quality imaging is delivered. Assists in educating staff technologists on modality imaging technology, exam protocols and procedures. Recognizes and implements actions related to quality concerns and performance. Does this position require Patient Care? Yes Essential Functions -Provide data consultation and staff support to clinical, operational process improvement individuals, patient safety individuals, etc. Perform imaging as needed. Assist in oversight of modality quality control procedures, and accreditation of applicable equipment per regulatory guidelines. -Collect data, implement new protocols, provide education to staff in efforts to improve quality within the department. Collaborates with site modality operations and vendors to support application training to ensure consistency of imaging and staff messaging. -Collaborate with leadership, staff, and radiologists to ensure exam protocols, patient care processes, and image quality are optimized. Critical thinking and problem-solving skills to review systems, identify quality issues, and propose solutions to correct quality errors. -Collects and analyzes quantitative and qualitative statistical data and work with vendors to resolve technical problems. Posses a basic understanding of DICOM, Networks, and Image distribution -Function as technologist to maintain optimal direct patient care skills and imaging skills -Provides radiation protection where applicable, and patient safety practices in accordance with prescribed safety standards; records digital images as directed for radiologist interpretation -Ability to adapt to multiple work environments and flexibility to support multiple locations across the enterprise Qualifications Education Associate's Degree Health Science required Can this role accept experience in lieu of a degree? No Licenses and Credentials Basic Life Support [BLS Certification] American Registry of Radiologic Technologists (ARRT) preferred Magnetic Resonance Imaging [R.T.(MR)(ARRT)] Experience MRI Technologist experience with multiple patient populations 5-7 years required quality experience 2-3 years preferred Knowledge, Skills and Abilities - Good communication skills. - Ability to effectively evaluate and problem solve. - Ability to work independently. - Ability to guide, teach, and motivate others. - Good business acumen and analytical skills. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 175 Cambridge Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $37.55 - $55.48/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a clinical program in obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Description As a member of Wave's Quality Assurance (QA) team, the Quality Assurance Specialist III, QA Training will be responsible for the oversight and maintenance of Wave's GxP Training program. This role partners with functional leaders to develop and maintain effective training that promotes employee competency and compliance readiness. This is an in-person role onsite at our Lexington facility requiring a minimum of 4 days onsite. Experience Bachelor's degree with a minimum of 4 years of related or transferable experience in the pharmaceutical or biotechnology industry, preferably in Quality Assurance/Training Experience in the administration of electronic learning management systems Veeva and/or ComplianceWire is preferred Experience in training program administration Experience working in a GMP manufacturing facility Responsibilities Manage the training program Creation and revision of role-based training curricula to align with functional responsibilities Manage onboarding of new employees by facilitating Quality onboarding training, verifying account creation and assigning curricula in Wave's Learning Management System Support the creation and revision of Training related SOPs, work instructions, training materials in collaboration with Subject Matter Experts (SMEs) Provide training and support for employees on the use of the Learning Management System (LMS) Support the development of training materials such as quizzes, instructor-led courses, and on-the-job training Facilitate GxP training for employees, as needed Oversight of training compliance across all departments, publish periodic training reports, and escalate compliance issues to management Collaborate cross-functionally to support LMS upgrades, vendor releases, and change management Manage or support the timely closure of relevant Quality System records Identify and participate in initiatives to improve the training program, LMS and training content Support development of Quality Management Review content to measure the health and effectiveness of the training program Support audits and regulatory authority inspections by providing training reports/documentation or other assigned tasks Oversight and timely response of training related inquiries Other duties as assigned Ensure timely completion of annual training review by providing support to functional leads and escalating issues to management Oversight of employees' CVs and job descriptions to ensure compliance Ensure timely generation and review of content for Annual GMP refresher training Key Skills Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance Superior organization skills with ability to manage competing priorities and meet deadlines Demonstrated ability to train GXP personnel one-on-one and in groups Works independently with minimal supervision Excellent team player with strong written and verbal communication skills Ability to work cross-functionally while providing excellent customer service Knowledge of instructional design principles for adult learning Champions continuous process improvement Proficient with MS Office Suite including Word, Excel and PowerPoint Pay Range External Disclosure Statement The annual base salary range for this position is $102,000 - $138,000 The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees' and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program. Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge. We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.

Title: Contract - Quality Assurance Specialist Reports to: Supervisor, Quality Assurance Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company's lead assets include a potential first-in-class oral therapy: VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta's pipeline has been built using the company's industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale. The Role: The QA Specialist is responsible for QA operations and QA documents/training. Additionally, the QA Specialist will support internal and external audits Here's What You'll Do: Ensure Vedanta facilities, utilities, manufacturing, and testing procedures and processes are compliant with GMP and phase-appropriate to support production and distribution by: Supporting QA Operations in manufacturing activities including but not limited to on floor support, executed document review, disposition and release (internal and external CMO), walkthroughs, etc. QA Document/Training in document control activities including document upload to QMS system and archiving of records for both document and training. Owning the revision of records and SOPS to align with GMP requirements as assigned. Collaborating with organization on the training of, and guidance/support of QMS system records such as Deviations, CAPAs, and Change Controls. Additionally owning QMS System records as required. Leading, supporting, and/or implementing improvement initiatives for QA and other organizations. Department functions: Department Processes: Continues to improve or develop Quality Assurance department processes/guidance for internal interactions or between Vedanta and external stakeholders. Maintain documentation in accessible format, ensure new documents are created and stakeholders notified/trained as assigned. General Support: Provide guidance and mentoring on best compliance and industry practices within and across departments. Provide advice to others upon request. Requirements: BS in Life Sciences with minimum 3 years in a pharmaceutical biotechnology environment. 2-3+ years in a Quality Assurance role. Proficiency in application of FDA 21CFR 211 and Part 11, ICH Guidelines, EU GMP regulations to supplier quality requirements. Demonstrated ability to meet timelines and achieve results in a team environment. Basic knowledge of drug development process, knowledge CGMP/GDP agency regulations (e.g., FDA, EMA, Health Canada, ICH), and ability to apply standards appropriately to situations. Past participation in regulatory inspections or audits is a plus. Excellent verbal and written skills, allowing for an open and effective dialogue between departments and clear communication to senior management on status and program needs. Ability to work independently and think strategically to improve current processes. Personal Competencies: self-awareness, integrity, problem analysis, communication, risk management. Interpersonal skills: team and consensus building, effective meeting management. Ability to work onsite in Cambridge, Monday through Friday. Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

Title: Contract - Quality Assurance Specialist Reports to: Supervisor, Quality Assurance About Vedanta Biosciences: Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company's lead assets include a potential first-in-class oral therapy: VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta's pipeline has been built using the company's industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale. The Role: The QA Specialist is responsible for QA operations and QA documents/training. Additionally, the QA Specialist will support internal and external audits Here's What You'll Do: Ensure Vedanta facilities, utilities, manufacturing, and testing procedures and processes are compliant with GMP and phase-appropriate to support production and distribution by: * Supporting QA Operations in manufacturing activities including but not limited to on floor support, executed document review, disposition and release (internal and external CMO), walkthroughs, etc. * QA Document/Training in document control activities including document upload to QMS system and archiving of records for both document and training. * Owning the revision of records and SOPS to align with GMP requirements as assigned. * Collaborating with organization on the training of, and guidance/support of QMS system records such as Deviations, CAPAs, and Change Controls. Additionally owning QMS System records as required. * Leading, supporting, and/or implementing improvement initiatives for QA and other organizations. Department functions: * Department Processes: Continues to improve or develop Quality Assurance department processes/guidance for internal interactions or between Vedanta and external stakeholders. Maintain documentation in accessible format, ensure new documents are created and stakeholders notified/trained as assigned. * General Support: Provide guidance and mentoring on best compliance and industry practices within and across departments. Provide advice to others upon request. Requirements: * BS in Life Sciences with minimum 3 years in a pharmaceutical biotechnology environment. * 2-3+ years in a Quality Assurance role. * Proficiency in application of FDA 21CFR 211 and Part 11, ICH Guidelines, EU GMP regulations to supplier quality requirements. * Demonstrated ability to meet timelines and achieve results in a team environment. * Basic knowledge of drug development process, knowledge CGMP/GDP agency regulations (e.g., FDA, EMA, Health Canada, ICH), and ability to apply standards appropriately to situations. * Past participation in regulatory inspections or audits is a plus. * Excellent verbal and written skills, allowing for an open and effective dialogue between departments and clear communication to senior management on status and program needs. * Ability to work independently and think strategically to improve current processes. * Personal Competencies: self-awareness, integrity, problem analysis, communication, risk management. * Interpersonal skills: team and consensus building, effective meeting management. * Ability to work onsite in Cambridge, Monday through Friday. Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection. Create a Job Alert Interested in building your career at Vedanta Biosciences? Get future opportunities sent straight to your email. Create alert

The Opportunity We are seeking a Quality professional to join our GCP Quality Assurance function at Relay Therapeutics (Relay Tx). Under the direction of the Senior Director, you will partner with your QA, QMS, and Clinical Development colleagues in supporting our clinical trial quality and strengthening of our clinical QMS as our pipeline evolves. At Relay Tx, we take Quality seriously, but we don't take ourselves too seriously. You'll have fun in our collaborative and energetic environment where you'll face new challenges every day. Your Role You will track and follow up on GCP/GCLP/GVP quality issues/events and CAPAs (internal and CRO) in Veeva to ensure timely closure and documentation You will support audit execution for investigator sites, clinical vendors, and internal processes, including working with SMEs to gather required documents, ensuring audit related timelines are met, and audit certificates are properly filed in the TMF You will assist CQA and clients in Precision Medicine with procedural document (e.g., SOPs) development and management. You will partner with the assigned CQA Lead to complete quarterly QA TMF reviews You will assist with QA review of GCP documents, including SOPs, protocols, and other study materials, as requested You will support inspection readiness and inspection management at the direction of the CQA Lead You will support CQA training initiatives, communication, and reporting efforts There is the potential to partner with an existing CQA Lead on assigned studies to build working knowledge of GCP activities Competencies for Success: You have a keen attention to detail, strong organizational skills, and a reputation for follow-through. You are a team player, flexible, and easy to work with in a fast and collaborative environment. You are solution oriented with a customer service approach. You have the ability to manage multiple priorities and proactively communicate status updates. Your Background: Bachelor's degree in a scientific field preferred 2-5 years of Quality Assurance/GCP/GCLP/GVP Operations experience in pharmaceutical or biotech industry Hands on experience with Veeva systems preferred Familiarity with GCP principles and clinical trial processes Competence in MS Office, especially the ability to develop polished PowerPoint presentations #JO1 About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

Job Title- Specialist QA Duration - 12 months with possible extension Key Skills - QA Pharma, Bio, biopharma, cGMP, validation, conformance, CAPAs, Change Bio-pharma space / Biologics . M-F onsite • Knowledge in cGMP / GMP manufacturing and technical knowledge in validation of pharmaceutical processes/systems/equipment • Project Management and organizational skills, including ability to follow assignments through to completion Direct: ************ - Ext 2065 Qualifications • Bachelor degree in a science or engineering discipline • No less than 5 years of experience in the pharmaceutical environment and validation Additional Information All your information will be kept confidential according to EEO guidelines.

Summary of Primary Responsibilities: The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. The position will provide floor support to production departments to include line clearances, in-process checks and assistance with investigations. The QA Compliance Specialist I performs quarterly audits support internal audits and participates in customer and regulatory audits as part of the Audit Team. Strategic Focus Area: Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and regulatory knowledge. Specific Responsibilities: Review and approve supplemental logs, charts and other documents in support of cGMP Operations. Review batch records for accuracy and completion prior to final release of product. Perform product releases specifically fills and intermediates lots. Coordinate product releases with distributors and customers as needed. Review and approve incoming materials for release. Provide quality assurance support of investigations including: nonconformance and root cause analysis. Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned. Issue, review and reconcile batch records as needed. Assist in the maintenance of the Quality System. Participate in project teams and perform other related duties as assigned. Job Complexity: Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance. Supervisor Responsibilities: none Required Qualifications: Bachelor's Degree or equivalent experience Medical device quality system management experience or an acceptable combination of education and experience will be considered. Internship experience may be considered. Knowledge of GMP, FDA, ISO requirements. Requires computer competence, including experience with database and Microsoft Office. Excellent written and verbal communication skills. Desired Experience, Knowledge, and Skills: Experience working in a GMP/ISO environment. Good presentation and organization skills. Attention to details. Capable of executing tasks per defined policies and procedures to resolve routine issues.

About this opportunity : In this position you will support day-to-day QA Operations activities such as batch record review, release of raw materials, review of AA and HVAC reports, customer corrections and following cGMP practices and guidelines. This role serves as a key quality interface between operational teams and quality oversight functions. Key Responsibilities: Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements. Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records. Responsible for knowledge of SAP system for release/rejection of raw materials. Maintains spreadsheets for the review cycles of quality documents. Interact /communicate with various department such as Manufacturing, Supply Chain and Quality Control. Coordinate corrections for quality documents internally and externally (e.g., client comments) Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections. Attend daily QA meetings. Support Senior/Lead Specialists. Gather/support corrections, quality metric reports to executive management. Provide strong link/communication between the QA function/activities with all other departments at the Milford site. Support Material Review Board (MRB) and labeling of raw materials (as required). Support Raw material re-evaluation process. Assist in customer documentation requests. Perform walk-through of manufacturing suites (as required). Help with internal audits of all GMP departments. Assist in deviation and investigation follow-up by coordinating data collection and document retrieval. Contribute to inspection readiness activities, document control harmonization, and trending initiatives in collaboration with QA Systems. Actively participate in continuous improvement efforts related to QA operations, document lifecycle management, and process ownership. Required Skills/Abilities: The job requires a BS/BA in science or equivalent work experience of at least 2 years' experience in either Production or Quality Assurance. Provide sound decision-making and guidance on all aspects of batch record review and raw material release. Provide strong link/communication between the QA Operations and QA Projects Departments. Interface with Manufacturing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition activities. Must be able to gown up and enter Manufacturing suites. The annualized salary for this position is $65,600.00 - $79,800.00.