Quality assurance manager jobs in Malden, MA

The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at Client. The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at Client to help ensure high quality standards and value delivery for our patients. Essential Duties and Responsibilities include, but are not limited to, the following: Performs QA review of executed development studies intended for regulatory submissions, included but not limited to draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate Corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards. Identifies and reports documentation errors and deviations from Protocols, SOPs or specifications in a timely manner. Responsible for communicating QA review, audit results and reporting. Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence. Qualifications: BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.

Alexander Technology Group is looking for a VP of Quality for a start-up client in the Portsmouth, NH area. This is full-time Salary: 200-250k range This would be heavily on-site in Portsmouth. No 3rd party applicants will be considered Requirements: Quality Strategy & Leadership Develop and execute the overall quality strategy aligned with company goals and regulatory expectations for combination products (e.g., FDA, EMA, ISO, ICH guidelines). Build and mentor a high-performing quality team, scaling resources as the company grows from early-stage development through commercialization. Serve as the company's Quality Management Representative and key liaison with regulatory authorities during inspections and audits. Quality Systems & Compliance Establish and maintain a robust Quality Management System (QMS) compliant with 21 CFR Parts 210, 211, 820, 4, and ISO 13485. Oversee quality operations including document control, training, CAPA, change control, supplier qualification, and internal audits. Ensure compliance with cGMP, GLP, and GCP standards as applicable to combination product development and manufacturing. Manufacturing & Supplier Quality Develop and manage supplier qualification programs and manufacturing oversight. Lead quality assurance activities related to contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and testing labs. Oversee product release, lot disposition, and complaint handling. Regulatory & Inspection Readiness Collaborate with Regulatory Affairs to ensure alignment on quality and compliance expectations across global markets. Lead preparation for FDA pre-approval inspections (PAI), ISO certification audits, and other regulatory inspections. Establish and maintain metrics to monitor product and process quality performance. If interested, please send resume to ************************

Millennium Precision is seeking new Team members to help in our manufacturing operations. Have you got what it takes to succeed The following information should be read carefully by all candidates. We are a growing, employee focused, contract manufacturer of Precision Swiss CNC style machined components for multiple markets. Position Overview: We are seeking an experienced Quality Lead/Mechanical inspection expert to join our dedicated team. xevrcyc The ideal candidate will play a crucial role in ensuring the quality and precision of our products through thorough inspections, documentation and quality control processes.

Department: Quality Assurance Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies' Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications. Key Responsibilities: Quality System and Computerized System Oversight Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities. Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption. Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management). Troubleshoot and resolve user issues as needed. Documentation and Record Management Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS). Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements. Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements. Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations. Training and Compliance Support Provide training and day-to-day support to employees on document control and system processes. Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections. Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement. Qualifications: Bachelor's degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered. 2-5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry). Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred. Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485). Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment. Collaborative, proactive, and adaptable work style aligned with a fast-paced, innovation-driven company. Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle array platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ****************** .

We're hiring a Director of Quality to lead QA/QC operations at our U.S.-based Contract Development & Manufacturing Organization (CDMO). This senior leader will ensure GMP compliance, oversee product release, and drive quality excellence across our clinical and commercial manufacturing programs. What You'll Do Lead QA, QC, and Quality Systems teams; build a strong quality culture Oversee batch record review, product disposition, and client quality interactions Maintain and improve GMP compliance, CAPA, deviations, change control, and training systems Prepare the site for regulatory inspections (FDA, EMA) and client audits Provide quality oversight for manufacturing, tech transfers, and validation activities Drive continuous improvement, data integrity, and inspection readiness What We're Looking For Bachelor's in science or engineering (advanced degree a plus) 10+ years in GMP pharmaceutical manufacturing; 5+ years in Quality leadership Strong command of FDA/EMA regulations, ICH guidelines, and CDMO environment Proven success managing inspections, audits, and client relationships Experience with aseptic, biologics, or high-potency APIs is a plus Why Join Us? Lead quality for a growing CDMO with diverse product portfolios Influence site strategy and partner closely with clients and regulators Competitive compensation, bonus, benefits, and development opportunities

Our client is seeking a POS Quality Engineer to join their team! This position is located in Canton, Massachusetts. Execute functional testing for the client's POS systems in a lab environment Validate new POS features, patches, upgrades, and configuration changes Troubleshoot issues across POS hardware, networking, integrations, and payment systems Review logs, identify root causes, and escalate defects to internal teams and vendors Collaborate with vendors delivering POS products to ensure quality and readiness Support daily version testing, weekly releases, and continuous enhancements Maintain test cases, regression suites, and documentation Ramp up on the clients POS systems, environments, and workflows Execute manual testing independently and efficiently Understand integration points with kiosk, mobile apps, loyalty, and payments Build relationships with product, engineering, and vendor teams Contribute to expanding and maintaining POS test automation frameworks Improve test coverage, defect identification, and issue resolution speed Work independently with minimal oversight while communicating affectively Support performance-related testing for high-volume transaction scenarios Help streamline testing workflows to support frequent deployments Desired Skills/Experience: 5+ years of POS Quality Engineering experience Hands-on experience with any POS system such as: Aloha, Toast, NCR, Oracle Symphony, or other enterprise/custom POS systems Experience with payment systems such as: VeriFone, kiosk integrations, loyalty platforms, mobile ordering, and web integrations Strong manual testing proficiency with the ability to execute tests quickly and accurately Ability to troubleshoot logs, hardware, and light networking issues Experience collaborating with third-party vendors on POS deliverables Familiarity with automation frameworks and ability to contribute to automation improvements Prior experience working in a POS lab environment (devices, staging stores, simulators) Strong communication, organization, and self-management skills Benefits: Medical, Dental, & Vision Insurance Plans Employee-Owned Profit Sharing (ESOP) 401K offered The approximate pay range for this position is between $55.00 and $65.00. Please note that the pay range provided is a good faith estimate. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and location. We comply with local wage minimums.

The Manufacturing Quality Engineer will be highly involved in the manufacturing aspects of the business, with an emphasis on Quality. The Quality Engineer will handle multiple projects and tasks throughout product development, product launch, and manufacturing. Additionally, this individual will ensure that product meets quality standards consistent with customer and other regulatory requirements. This role also supports plant activities in customer issues, supplier issues, and initiate corrective actions with an emphasis on process improvement. The mission of the Manufacturing Quality Engineer is to enhance the quality of materials and products through detection, analysis, and correction of conditions leading to nonconformance. Job Functions: Support, maintain, and sustain QMS. Audit processes and products. Complete first piece inspection activities. Support incoming inspection and communicate with suppliers regarding SCARS and other issues. Confer with engineers about the quality assurance of new products and development of procedures and quality requirements. Develop and update PFMEAs and Control Plans, as necessary. Assist in resolving customer quality issues. Investigate nonconformance reports and coordinate corrective / preventive actions. Perform internal audits and mentor process owners toward improvement. Participate on improvement teams for safety, quality, or cost. Collect and analyze internal/external quality data and report. Perform other duties as assigned to support the advancement of quality systems and operations. Skills: Good team player. Good problem-solving skills. Effective communication skills. Strong computer skills and knowledge of MS Office Suite. Working knowledge of print and specification interpretation. Required Experience: BS in Mechanical Engineering, or another technical field. 2+ year experience in Quality or Manufacturing background in diecast or injection molded products. Hands on experience measuring with various gauges and tools. Experience in 5S, lean or other continuous improvement methods. PPAP, QMS, NADCAP, and ISO9001 standards experience

Job Posting Start Date 11-03-2025 Job Posting End Date 01-31-2026 At JetCool, a Flex company, we're at the forefront of liquid cooling innovation, delivering advanced solutions that empower our partners in AI and high-performance computing. United by a shared purpose, our teams are pushing the limits of what's possible and tackling complex challenges. A career at JetCool offers the opportunity to make a real impact by helping build smarter, more sustainable data centers. Together, we're not just advancing technology - we're redefining cooling standards to create a more sustainable tomorrow. Job Summary JETCOOL Technologies is seeking an experienced Quality Manager in Littleton, MA to provide the analytics and guidance to effectively manage product and process quality for all JetCool products. Strong preference will be given to those who have designed and implemented total QMS systems in a start-up environment. JETCOOL Technologies is a fast-moving technology company spun out of MIT and now a member of the Flex family. Our technology provides game-changing cooling solutions for aerospace, electric vehicles, and data centers. Join us to be part of one of today's fastest growing industries, while having a positive impact on society sustainability through innovative technologies. What a Typical Day Looks Like: Develops, implements, and coordinates product assurance programs to prevent and eliminate defects in existing products and future new products Leads the creation and implementation of a comprehensive QMS system that identifies quality metrics and trends across the entire supply chain via customer field data leading to proactive management decision making Work with external suppliers, domestically and internationally to validate in-factory quality management tools, controls and reporting mechanisms. Integrate supplier quality data into JetCool quality control methods assuring timely and collaborative management of on-going product quality. Perform regularly scheduled on-site quality audits at key suppliers, assuring compliance with JetCool quality standards. Participates in, and work with Design Engineering during NPI development programs ensuring Design for Quality considerations are embedded in and validated the NPI release process Evaluates and leads the discovery of field return quality issues, drives root cause investigations, and recommends corrective actions Establish statistical process control measurement methods to gather product and process quality performance Acts as the point of contact for all internal and external quality issues across the supply chain (suppliers, raw stock, WIP, finished goods, warehouses, field deployments) The Experience We're Looking to Add to Our Team: 4-year college degree, masters preferred Minimum of 7-10 years relevant industry experience Experience working with fluid-mechanical systems consisting of fluids and pumps is preferred. Demonstrated experience building QMS management systems in partnership with global suppliers. Experience working with PLM and ERP systems. Experience working with Customers as a prime point of contact for fielded quality issues. Experience working with, integrating and converting product and process quality data into actionable information. Experience working with regulatory bodies (e.g. Nemko, UL, TUV, CSA) hosting factory audits and ensuring in factory controls are in place and up to date. Ability to travel to domestic and international suppliers, 10%-20% What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement Pay Range (Applicable to Massachusetts)$107,900.00 USD - $148,400.00 USD AnnualJob CategoryQuality Is Sponsorship Available? No JetCool is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at JetCool, you must complete the application process first).

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 .

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.

About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Director of External Quality Assurance, you will report to Head of Technical Quality to provide Quality oversight on manufacturing operations at Contract and Development Manufacturing Organizations (CDMOs). The scope of work will include Sana's programs from pre-clinical, clinical and subsequently commercial operations serving the US and ex-US regions. The role will include performing Quality person in the plant (PIP) activities at CDMOs for critical operations. This role will also require supporting external audits of Sana's suppliers and contract services. Approximately 30% travel may be required. What you'll do * Provide leadership and quality oversight for operations at Sana CDMOs, which may require onsite support at the CDMO. * Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs. * Perform batch review and ensure timely and accurate batch disposition of materials and/or Sana products. * Partner with technical departments to help ensure success of technical transfer activities from Sana to the CDMO partners. * Partner with CDMO to identify and address gaps or areas for improvement in systems, procedures, and quality initiatives. * Collaborate with other functions in CDMO Manufacturing, QC, and Process Development teams to evaluate, investigate and resolve issues. * Responsible for batch release of Sana products manufactured at CDMOs. * Understand the Quality Management System and influence phase-appropriate SOPs, change control, investigations, CAPA, compliance, document management, training management and validation. * Establish and maintain Quality Technical Agreements and ensure alignment with other legal contracts as needed with CDMOs and CTLs. * Maintain a Quality Risk Management system to identify and mitigate compliance risks. * Ensure that CDMO facilities, utilities, and equipment are maintained in a validated or qualified state. * Support qualification activities for suppliers, contract testing laboratories, contract manufacturing organizations and contract services. * Perform supplier audits in accordance with Sana requirements. * Support the complaint program; review and approve the complaint reports to ensure all quality complaints are thoroughly investigated and ensure the CAPA plans for the resolution of the complaints are developed and executed. * Serve as the Sana business process owner for Quality batch disposition activities. * Support inspection and/or audit readiness activities for inspections by Health Authorities, and partners. What we're looking for * Self motivated leader who can influence others and exercise sound judgement when managing issues during critical operations. * Experience in working with CDMOs in various product lifecycle stages. * Operational experience in manufacturing aseptic environments, in quality or manufacturing. * Experience in leading and managing complex investigations. * Experience in batch disposition activities. * Familiar with the US, EMA, and ICH regulations and guidance documents * Effective communicator where you can articulate concerns and/or issues in a clear and concise manner. * Demonstrated ability to engage team members across diverse teams. * Ability to effectively prioritize and deliver high-quality results on tight timelines. * Demonstrated ability to independently problem solve including the ability to devise and implement practical solutions to resolve QA issues while being mindful of impact to timelines, resources and conflicting priorities. * Experience in inspection readiness activities, presenting during inspections and/or hosting Health Authority inspections. * Bachelors or Masters plus 10-12 years of work experience. What will separate you from the crowd * Cell and Gene Therapy product experience preferred * Experience in expedited release processes What you should know * Approximately 30% travel may be required. * The role will be based at the Sana Cambridge, MA location and will require onsite presence. * The base pay range for this position at commencement of employment is expected to be between $200,000 - $250,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience How we work together for patients * Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations * Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity * Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal. We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9897 As Director, Clinical Quality Assurance Compliance you will lead quality assurance activities across clinical development programs in global teams. This role focuses on implementing a proactive, risk-based quality strategy, ensuring GCP compliance, fostering a culture of quality within the Global Development Organization whilst supporting delivery of our clinical trial portfolio. Responsibilities * Develop and implement a proactive, risk-based Clinical Quality Strategy for assigned high-priority trials or programs, ensuring inspection readiness and GCP compliance * Collaborate with internal teams, collaboration partners as well as external vendors (e.g. CROs) to identify, investigate, and remediate clinical trial risks and quality issues, including CAPAs and effectiveness checks * Actively contribute to Clinical Trial teams by providing quality guidance and reviewing key study documentation * Enable continuous inspection readiness and compliance with GCP, regulatory requirements, and internal standards * Lead or support inspection preparation, facilitation, and follow-up activities * Review and manage Quality Agreements with CROs and other vendors, ensuring compliance with agreed standards * Lead and develop a team, fostering transparency and proactive communication * Drive a culture of quality and continuous improvement across the Global Development Organization, including authoring and reviewing clinical quality procedures. * Acting as an ambassador for quality: ensuring that quality is an enabler of delivery. Qualifications Education * University degree in life sciences; advanced degree preferred Experience * Profound professional experience (beyond 10 years) in a GCP-regulated environment * Strong GCP expertise gained in a senior Quality Management and / or Clinical Operations role. * Strategic and Risk-based mindset with experience developing quality strategies at program level * Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA) * Experience in team leadership and development (in the GCP environment preferred) * Experience in managing, hosting or supporting regulatory authority inspections (EMA/FDA/MHRA) * Proficiency in MS Office and electronic quality management systems * Fluent in English (Mandarin is a plus) Expected Pay Range: $202000/year to $247000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Your Benefits: BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: * Medical, Dental and Vision Insurance * Life, AD&D, Critical Illness Insurance * Pre-tax HSA & FSA, DCRA Spending Accounts * Employee Assistance & Concierge Program (EAP) available 24/7 * Parental and Childbirth Leave & Family Planning Assistance * Sitterstream: Virtual Tutoring & Childcare Membership * Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. * 401(K) Plan with Company Match * Tuition Reimbursement & Student Loan Assistance Programs * Wellbeing Incentive Platforms & Incentives * Professional Development Programs * Commuting Allowance and subsidized parking * Discounted Home, Auto & Pet Insurance …and more! More details to be shared. Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge's thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology. Apply now - We look forward to your application! Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you ****************

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more ************************* and follow us on X, LinkedIn and Facebook. Role Summary: The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements. This role is based in Waltham, MA. Primary Responsibilities Include: * Inform and contribute to audit planning and strategy * Perform and/or coordinate clinical site and vendor audits * Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs * Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends * Support inspection readiness activities and co-host regulatory inspections * Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements * Conduct and/or manage the qualification and oversight of service providers * Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness * Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity * Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings * Support investigational new drug (IND) applications and related correspondence with global regulatory authorities Education and Skills Requirements: * Bachelor's degree in a scientific, allied health, or medical field required; Master's degree preferred * Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience) * Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements * Broad clinical development experience across all phases (Phase I through BLA/NDA) * Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages * Proven experience developing and implementing risk-based clinical quality assurance programs * Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings * Skilled at effectively communicating quality events and outcomes to internal stakeholders * Excellent interpersonal, verbal, and written communication skills * Working knowledge of multiple therapeutic areas is a plus * Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines * Flexible and creative problem solver with a proactive mindset * Highly collaborative team player who fosters open communication and cross-functional cooperation * Willingness to travel up to 20% based on business needs #LI-Onsite MA Pay Range $190,000-$232,800 USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Quality Assurance is a strategic leadership role responsible for overseeing key aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering's ongoing development programs with local, state, federal, and international requirements. This position will be supportive in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: * Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance * Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. * Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance. * Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding * Work on qualification and validation plans, assure proper batch releases and disposition. * Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA) * Provide quality input on contracts and serve as a point person for negotiations of quality agreements. * Champion a culture of quality and continuous improvement across manufacturing and development operations. Desired Skills and Qualifications * Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry * Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements * Demonstrated hands on experience working on complex projects. * In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. * Strong partnering and communication skills required, as well as project management skills. * Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. * Ability to work effectively in a collaborative, fast-paced environment. Pay scale: $175-210 annually, final offer to be commensurate with education and depth of experience, with potential for equity participation, bonus and comprehensive benefits. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

The Ryan White Dental Program (RWDP) is a comprehensive dental access program for persons living with HIV/AIDS in Massachusetts and Southern New Hampshire, funded under Ryan White Part A and with funds from the Massachusetts Department of Public Health. Services funded are recruitment of dentists and preventive, diagnostic and therapeutic services rendered by licensed dentists and dental hygienists. Under the supervision of the Director of the Ryan White Dental Program , the Clinical/Quality Management Program Manager of RWDP will be responsible for clinical quality improvement, reviewing eligibility for clients accessing services; providing technical and monitoring assistance to assure dental vendors attain contracted goals & objectives; monthly reporting of program activities; maintaining consistent contact with dental providers and other parties as needed; and working collaboratively with program & fiscal staff to ensure system accountability. Responsibilities Review dental treatment plans and history to determine appropriate options for people living with HIV (PLWH) seeking dental care to be reimbursed by the program Provide initial review of dental claims, including client eligibility, dental billing codes, and prior approvals Review past billing and client dental records to prevent duplicate or improper billing for services Monitor monthly prior approval expenditures and assist in reconciliation of payments in coordination with other Dental and BPHC fiscal staff With the assistance of other RWDP staff, review and update annual Scope of Services documents for dental contracts, including client eligibility, fee schedules, and other requirements With the assistance of other RWDP staff, develop and update a Standard Operating Procedures (SOP) manual, including policies and procedures for Dental staff, vendors, and clients; the client enrollment process; recruitment of vendors; and reimbursement process for dental services. Draft and revise quality management plan for the program, including tracking of health and quality of life indicators, dental standards of care, and quality improvement activities Conduct regular research into the most current dental best practices and disseminate such content to a diverse audience, including HIV service providers and clients Provide support on presentations to both internal and external stakeholders on the impact of services on the oral health care needs of PLWH Regularly attend programmatic meetings Handle communication with clients, dental providers, and others Perform other duties as required

Full-time Description To provide quality assurance and administrative supports to the day program management team, specifically to ensure the accuracy of documentation related to annual certification. PAY: $20/hr. Essential Responsibilities: Review daily and monthly documentation and billing for accuracy and compliance with state regulations Track and order building and office supplies Track, schedule and follow up on all van maintenance Monitor all building maintenance concerns and report to facility manager Train new hires on documentation systems Maintain certification files and execute annual certification review with state certifiers Qualifications: Education and Experience High school diploma or equivalent required 1-2 years' experience in the field of developmental services preferred Experience with writing and reviewing documentation for quality and accuracy in a human services setting preferred Proficiency in Microsoft Office Suite and database systems Valid driver's license and access to a safe operating vehicle during scheduled working hours Skills and Abilities Ability to work both independently and collaboratively as part of a team Maintains high attention to detail Strong computer literacy (including but not limited to proficiency with word processing, spreadsheets, email, and database software-MS Office) Ability to multi-task and meet deadlines under very specific timeframes Maintains a high level of organization Ability to communicate effectively (reading, writing, speaking) in English Strong customer services skills Ability to work well under pressure Note: The Moore Center considers the ability to speak, read and write English an essential functions of all positions. Training requirements, essential responsibilities and the physical requirements listed are considered essential to ensure the safety and well-being of the clients we serve. We will consider alternate methods of accomplishing tasks to accommodate any physical limitation(s) an employee might have. In an emergency, all staff may be required to perform activities that are above and beyond what is indicated on this job description to ensure the safety of the individuals we serve. All staff must adhere to the NH state law requiring mandated reporting of suspected abuse, neglect, or exploitation. Additionally, staff are required to maintain criminal, motor vehicle, DCYF, OIG, and Bureau of Elderly and Adult Services record checks that meet agency standards. Staff are also required to travel and transport clients when applicable. This includes having access to a reliable vehicle, a valid driver's license and maintaining comprehensive personal auto insurance of $100,000/300,000. Salary Description $20/hr.

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.

We are looking for an experienced Construction Quality Control Manager to join our team. This role is responsible for developing, implementing, and managing quality control systems to ensure that construction activities and outputs comply with project specifications, company standards, and regulatory requirements. This role is critical in ensuring the delivery of high-quality of DEW Construction's projects through oversight, inspection, and coordination with project teams, subcontractors, and third-party inspectors. DEW's Vision, Mission, and Core Values: Vision Statement: To be the go-to construction partner known for our unwavering commitment to the success of every project. Mission Statement: To build a team of professionals who share our core values and foster a culture where everyone can thrive and grow together. Core Values: Optimism: We share a positive mindset, believing in opportunities over obstacles. Initiative: We are self-motivated, proactive problem solvers. Accountability: We are committed to a culture of ownership, personal accountability, and safety. DEW's Vision, Mission, and Core Values are explicitly integrated into our daily decision-making, leadership behaviors, employee training, performance evaluations, and company culture. We use them as a guiding principle for all activities and hold employees accountable for upholding them, essentially making them a tangible part of the company's identity and operations. Our aim is to ensure we are aware of these guiding principles and feel motivated and encouraged to continue integrating them into our daily lives Essential Functions: Quality Assurance Program Development: Develop and maintain project-specific Quality Control Plans (QCPs). Ensure construction compliance with applicable project documents (Plans, Specifications, submittals, standards, regulations, and customer requirements. Lead quality meetings and contribute to project pre-construction planning efforts. Inspection and Testing: Oversight and documentation of inspections, materials, workmanship, and final products. Coordinate and document third-party testing and special inspections. Identify and correct deficiencies with the project team utilizing Procore Observations to document deficiencies and non-compliant work as well as corrective action plans. Documentation and Reporting: Maintain detailed and organized quality records, including inspection logs, test reports, and compliance certifications. Prepare and submit daily quality reports and project QA/QC status updates. Review and approve subcontractor and supplier quality documentation. Team Leadership and Communication: Serve as the primary point of contact for quality control matters on the job sites for the Project Teams. Train and mentor construction staff and subcontractors on quality standards and procedures. Facilitate communication between project management, clients, regulatory agencies, and contractors. Prepare monthly QAQC Reports to identify areas of concern, compliance, recommendations to improve performance. Continuous Improvement: Analyze quality trends and data to identify opportunities for process improvement. Recommend and implement best practices to enhance overall construction quality. Essential Experience: Education: Bachelor's degree in Civil, Mechanical, or Structural Engineering, Construction Management, or related field preferred. Equivalent experience may be considered. Experience: Minimum 5-7 years of experience in construction quality control, preferably in commercial, industrial, or federal/military projects or requisite field experience. Prior experience with government contracts (e.g., USACE/NAVFAC) is a plus. Certifications (Preferred): USACE Construction Quality Management (CQM) Certification OSHA 30-Hour Certification ACI, ICC, or other relevant technical certifications Skills & Abilities: Strong knowledge of construction methods, materials, standards, and regulations. Excellent attention to detail, organizational, and analytical skills. Proficient in reading and interpreting blueprints and specifications. Strong written and verbal communication skills. Proficiency with MS Office and construction management software (Procore, Primavera, Bluebeam). If you are interested in being part of an innovative and collaborative team, in a challenging and rewarding work environment, we want to hear from you! We are always trying to stay a step ahead of emerging trends in the industry. Every employee is part of the process and part of our success. DEW's philosophy is to invest in people and inspire them to bring the best of themselves to work every day. In addition to offering competitive wages and a comprehensive benefits package, employees are given opportunities to learn, develop and grow. These are the reasons DEW is named amongst the top places to work in New Hampshire and Vermont. We are an Equal Opportunity Employer.