Quality Assurance Manager jobs at Medical Billing - 118 jobs

Are you a current UMass Memorial Health caregiver? Apply now through Workday. Exemption Status: Non-Exempt Hiring Range: $29.35 - $39.53 Please note that the final offer may vary within this range based on a candidate's experience, skills, qualifications, and internal equity considerations. Schedule Details: Monday through Friday, Weekends (Saturday and Sunday) Scheduled Hours: 7a-7p 7p-7a Shift: 4 - Mixed Shift, 12 Hours (United States of America) Hours: 40 Cost Center: 10020 - 2366 Emergency Med Svcs Union: NAGE (National Association of Government Employees) This position may have a signing bonus available a member of the Recruitment Team will confirm eligibility during the interview process. Everyone Is a Caregiver At UMass Memorial Health, everyone is a caregiver - regardless of their title or responsibilities. Exceptional patient care, academic excellence and leading-edge research make UMass Memorial the premier health system of Central Massachusetts, and a place where we can help you build the career you deserve. We are more than 20,000 employees, working together as one health system in a relentless pursuit of healing for our patients, community and each other. And everyone, in their own unique way, plays an important part, every day. Personnel who have competency in airway management, including Medication Assisted Intubation/Rapid Sequence Intubation (MAI/RSI) as well as experience managing episodes of acute clinical decompensation in medically ill patients serve in the North Pavilion (PAV) in capacities consistent with their level or training and scope of practice. All work performed in the hospital will be done under the clinical supervision of the attending physician. Major Responsibilities: 1. Working in a collaborative fashion as part of the care team with physicians, APPs, PCAs, Unit Secretaries, Respiratory Therapists, and RN staff. 2. When summoned in case of critical decompensation or cardiac arrest, at the direction of the physician or APP, will be responsible for management of the patient's airway according to the Resuscitation and Airway Management Specialist (RAMS) training and scope. The airway procedures will include: o Use of LMAs and other supraglottic airways. o BVM ventilation. o Use of PEEP valve during ventilation. o Direct laryngoscopy. o Video laryngoscopy. o Orotracheal and nasotracheal intubation. o Use of bougie to assist in intubation. o Cricothyrotmy in Cannot intubate, cannot ventilate (CICO) situations. o Placement of orogastric or nasograstric tube. 3. Participate in a program of patient monitoring (known as “Overwatch”) with the following general characteristics: o Meeting with other clinical staff to identify patients at elevated risk of clinical decompensation and monitoring these patients for any acute changes throughout the course of a shift. o Responding and interfacing with the interdisciplinary team to help identify management strategies for patients identified in the above activities o Participate in clinical rounds in coordination with the interdisciplinary care team to review patients' condition and evaluate clinical progress. 4. Establish and maintain peripheral IV access when called upon by the clinical team in cases of patients with difficult IV access. 5. Assisting with transport of critical patients to and from areas of the hospital while monitoring for any acute changes. 6. Performing phlebotomy when needed urgently for “STAT” blood draws or in the case of actuely decompensating patients. 7. Responds according to hospital policies to Visitor/Employee/Outpatient (VEO) emergencies as needed All responsibilities are essential job functions. Standard Staffing Level Responsibilities: 1. Complies with established departmental policies, procedures, and objectives. 2. Attends variety of meetings, conferences, seminars as required or directed. 3. Demonstrates use of Quality Improvement in daily operations. 4. Complies with all health and safety regulations and requirements. 5. Respects diverse views and approaches, demonstrates Standards of Respect, and contributes to creating and maintaining an environment of professionalism, tolerance, civility and acceptance toward all employees, patients, and visitors. 6. Maintains, regular, reliable, and predictable attendance. 7. Performs other similar and related duties as required or directed. II. Position Qualifications: License/Certification/Education: Required: 1. Certified in CPR - Basic Rescue by either the American Red Cross or the American Heart Association. 2. Certified in Advanced Cardiac Life Support by the American Heart Association. Experience/Skills: Required: 1. At least three years of experience in the care of patients with critical illness within the last 5 years. 2. Experience with Rapid Sequence Intubation with at least 20 intubations performed. 3. Experience with surgical cricothyrotomy. 4. Experience with placement of nasogastric tubes. 5. Experience with placement of peripheral IVs. 6. Experience and training on placement of Intraosseos access device. 7. Demonstrated ability to work well under often stressful situations. 8. Strong organizational and interpersonal skills. 9. Effective oral and written communication skills. Preferred: 1. Minimum three years of experience in an urban EMS service integrated with a municipal first response system. 2. Pediatric Advanced Life Support (PALS) certification. Unless certification, licensure or registration is required, an equivalent combination of education and experience which provides proficiency in the areas of responsibility listed in this description may be substituted for the above requirements. Department-specific competencies and their measurements will be developed and maintained in the individual departments. The competencies will be maintained and attached to the departmental job description. Responsible managers will review competencies with position incumbents. III. Physical Demands and Environmental Conditions: Work is considered medium. Position requires work indoors in a patient care environment. Constantly: Working Indoors. Frequently: Sitting, Standing, Walking, Pushing, Pulling, Twisting, Reaching, Performing Repetitive Movements, Precise Motor Skills required, Precise Hearing required, Precise Vision required; Lifting, Carrying, Pushing, and Pulling - Less than 10 pounds to 20 pounds. Often: Balancing, Bending, Kneeling, Grasping, High Level of Stress; Lifting, Carrying, Pushing, and Pulling - 20 pounds to over 100 pounds. Never: Climbing, Kneeling, Working Outdoors, Working in Temperature Extremes, Working at Heights. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. We're striving to make respect a part of everything we do at UMass Memorial Health - for our patients, our community and each other. Our six Standards of Respect are: Acknowledge, Listen, Communicate, Be Responsive, Be a Team Player and Be Kind. If you share these Standards of Respect, we hope you will join our team and help us make respect our standard for everyone, every day. As an equal opportunity and affirmative action employer, UMass Memorial Health recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity and expression, protected veteran status or other status protected by law. If you are unable to submit an application because of incompatible assistive technology or a disability, please contact us at ***********************************. We will make every effort to respond to your request for disability assistance as soon as possible.

Newark, DE, United States Marlborough, MA, United States Are you a strategic leader with a passion for driving compliance, quality excellence, and continuous improvement in a regulated environment? At Hologic, we are seeking a **Senior Manager, Quality Assurance** to lead the development, implementation, and maintenance of our divisional Quality Management System (QMS). In this role, you'll oversee key quality processes, including CAPA management, audits, change management, and Quality Management Reviews, while fostering a culture of procedural compliance and continuous improvement. You'll partner cross-functionally, Lead a high-performing team, and ensure adherence to global regulatory standards. If you're ready to make a meaningful impact by ensuring the safety, reliability, and quality of life-saving products, we encourage you to apply! **Knowledge:** + Advanced understanding of Quality Management Systems (QMS) and electronic documentation systems. + Expertise in FDA 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and other global regulatory standards. + Expertise in managing CAPA processes, risk-based compliance strategies, and change management controls. + Familiarity with root cause methodologies, risk management, and compliance-driven processes. + Knowledge of Lean Manufacturing principles, Kaizen, Kanban, Poke Yoke, and visual factory ideology. + Awareness of quality assurance standards, including statistical data analysis for quality performance. **Skills:** + Proven ability to recruit, lead, and develop a high-performing team with strong Leading and coaching capabilities. + Exceptional leadership skills with the ability to influence and communicate effectively across all levels of the organization. + Strong project management skills to lead quality initiatives, manage resources, and meet financial objectives. + Analytical skills to collect, compile, and interpret quality data to drive decision-making and improvements. + Ability to support audits and regulatory inspections as a Subject Matter Expert (SME) and ensure readiness. + Strong collaboration skills to establish cross-functional networks and drive procedural compliance. + Preferred skills: Lean or Six Sigma certification for driving process efficiency and continuous improvement. **Behaviors:** + Strategic thinker, with a focus on aligning quality objectives to organizational goals and regulatory requirements. + Detail-oriented and proactive, ensuring timely resolution of compliance issues and adherence to QMS processes. + Collaborative and relationship-oriented, fostering strong partnerships across operations, R&D, and other functions. + Promotes a culture of continuous improvement, identifying lessons learned and implementing new tools and methodologies. + Accountable and results-driven, with a commitment to delivering high-quality outcomes while meeting financial objectives. + Customer-focused, ensuring products meet the highest standards of safety, quality, and reliability. **Experience:** + Bachelor's degree required; Master's degree or PhD preferred. + 8+ years of experience with a Bachelor's degree or 5+ years with a Master's degree in Quality Assurance or a related field. + Prior experience in FDA, Notified Body, ISO, or other regulated manufacturing settings is beneficial. + Proven success in leading quality initiatives, CAPA processes, audits, and change management in a regulated industry. + Experience working with Operations and R&D teams to drive quality and compliance is advantageous. + Previous managerial or supervisory experience is preferred **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 $134,700-$224,500 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

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.

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 .

Responsible for overseeing the day-to day activities of the complaint team, works to assure timely case/complaint review and assignment. Responsible for managing the escalation process of potentially reportable complaints with attention to country specific reporting timeliness The QA Manager works with cross func tional teams to support complaint escalations, investigations and field actions. Responsibilities Responsibilities Manages the complaint team to ensure accuracy and timely risk review and thorough complaint investigations are completed. Responsible for product family specific systems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards. Ensures timely and thorough review of all com plaints and inquiries, prioritizing potentially reportable events. Escalate any potentially reportable complaint or inquiry, communicates with the cross functional team and management, drives the post market Risk Analysis Worksheet (RAW) process through completion. Communicates updates on escalations, priorities, and complaint status to leadership and in various meetings. Chairing meetings and providing guidance and direction to the RAW team. Trains and develops subordinates, as appropriate, to achieve duties and responsibilities Coordinates and monthly complaint trend review meetings with appropriate departments and ensures that escalations, investigations and CAPA Actions are taken to remediate negative trends or for specific customer complaint issues, determination and resolution of root causes for complaints. Provide complaint inputs to the post market surveillance reporting process Responsible for maintaining Complaint KPI data and reporting as necessary Responsible for gathering complaint and RAW data for Post Market Surveil lance and updating the RA reports including assessing newly identified risks. Follows regulatory requirements for complaint management. Establish and maintain a system to review literature and social media for complaints. Manages tasks supporting complaint investigations, Including returned parts and external as signments. Supports investigation activities and provides guidance for resolving product malfunctions Performs other related duties as assigned. Networking/Key relationships Medical Affairs R&D Regulatory Affairs IT /Cybersecurity Global Affiliates Operations Other technology centers Qualifications Minimum Knowledge & Experience for the position: Bachelor's degree in relevant field (i.e. Life Science, Biochemistry, Engineering or similar 10 years (with a Bachelor's) or 8 years (with a Master's) relevant experience. 5 years of supervisory or people management experience. Skills & Capabilities: Strong knowledge of FDA, Medical Device and IVD regulations and quality systems related to complaints, and statistical techniques and the ability to train others related to these requirements. Demonstrated ability to organize complex work assignments and oversee analyst to complete tasks and project on time Must possess strong investigational skills to determine root cause, identify and implement effective corrective actions Strong interpersonal communication skills Strong customer focus and continuous improvement mentality. Excellent written and oral communication skills Ability to drive Risk Management, escalation and complaint closure processes. Critical thinking skills, including the ability to analyze and trend data and communi cate concerns as needed. Travel Requirements: N/A The annual base salary range for this role is currently $140,000 range to $160,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

Pay & Benefits: * Competitive salary: $95K to $110K annually * Comprehensive health, dental, and vision insurance * Life and accidental death (AD&D) insurance * Employer-funded pension plan * 403(b) retirement savings plan * Generous paid time off, holidays, and bereavement leave The Opportunity:Whittier Street Health Center is seeking a full-time Director of Quality Assurance & Quality Improvement (QA/QI) to lead organization-wide quality, performance improvement, and patient safety initiatives within a Patient-Centered Medical Home. This senior leadership role is ideal for an experienced quality professional who can translate data into action, partner effectively with clinical and operational teams, and drive a culture of continuous improvement grounded in health equity, cultural humility, and patient-centered care. Key Responsibilities: * Lead and oversee Whittier's organization-wide QA/QI strategy, performance improvement initiatives, and implementation * Ensure compliance with Joint Commission, NCQA, HRSA, and other regulatory standards * Supervise and develop QA, Utilization Management, Data, and Care Coordination teams * Oversee internal audits, peer review, incident reporting, risk management, and patient safety activities * Analyze clinical, operational, and patient experience data to identify trends and drive measurable improvement * Partner with clinical, behavioral health, dental, wellness, and access leaders to support integrated care delivery * Support grant-funded programs, quality dashboards, and required reporting Requirements: * Master's degree in Nursing, Public Health, Healthcare Management, or a related field * Minimum 5 years of experience in quality assurance, quality improvement, or performance improvement in healthcare * Prior clinical operations experience strongly preferred * At least 2 years of management or supervisory experience * Strong working knowledge of Joint Commission and NCQA standards (PCMH, PCCC, PRIME) * Experience with chronic care models, care coordination, and population health initiatives * Proficiency with Microsoft Excel, Word, and Outlook; Epic EMR experience strongly preferred Join Our Team! Be part of a center of excellence at Whittier Street Health Center, where quality improvement is central to advancing health equity and delivering exceptional care. Pay: $95,000.00 - $110,000.00 per year Benefits: * Dental insurance * Employee assistance program * Flexible spending account * Health insurance * Life insurance * Paid time off * Referral program * Retirement plan * Tuition reimbursement * Vision insurance Experience: * QA, QI, or performance improvement in healthcare: 5 years (Required) * management or supervisory: 2 years (Preferred) Work Location: In person

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 the Quality Assurance (QA) team, the Quality Assurance (QA) Manager, Vendor QA will lead the vendor management program, internal and some external audits, as well as some operational support where needed. This individual will collaborate cross-functionally with representatives from Supply Chain (SC), Manufacturing, Quality Control (QC), Information Technology (IT) and other teams in support of preclinical, clinical, and commercial product development. 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 7 years of related experience in a Quality Assurance organization, with at least 5 years' experience in Vendor Qualification Experience working in a GMP environment in the pharmaceutical or biotechnology industry, GXP experience is a plus Experience supporting both investigational phase and commercial products is strongly preferred Demonstrated experience conducting and managing supplier audits and related documentation Experience conducting internal audits Responsibilities: Lead the end-to-end vendor qualification process, ensuring compliance with regulatory and company standards Manage the creation and revision of vendor management procedures Plan and conduct onsite or remote supplier audits Identify, assess, and mitigate supplier related risks Drive continuous improvement initiatives for the vendor management program Plan and conduct/support internal audits Manage quality records related to vendor management in Veeva Provide guidance to internal stakeholders on vendor management process Support supplier correction action reports (SCARs) and supplier change notifications (SCNs) processes Report on KPIs related to Supplier Qualifications and internal audits Adhoc tasks as assigned by manager Key Skills: Strong understanding of vendor management process Conducting internal and supplier audits Problem Solving Collaboration with suppliers and internal stakeholders Knowledge of electronic solutions including Veeva, SmartSheets and SharePoint strongly preferred Ability to work independently Ability to travel domestically and internationally, up to 25% Pay Range External Disclosure Statement The annual base salary range for this position is $125,000 - $169,000. 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.

011230 CA-Provider Engagement & Performance The Program Manager, in collaboration with the Sr Director of Delegation Partnerships and Performance, is responsible for advancing provider quality performance across CCA's contracted network, with a focus on value-based arrangements and network-wide engagement strategies. The program manager is responsible for managing and implementing key population health and network quality initiatives to achieve high performance on CCA's Population Health goals; including Medicare Star measures, Medicaid-Medicare Plan withhold measures, quality performance metrics incorporated into other CCA contracts, health equity, Culturally and Linguistically Appropriate Services, Consumer Assessment of Healthcare Providers and Systems (CAHPS), and social determinants of health (SDOH) measures. The Program Manager will work collaboratively with our provider network and Quality teams to identify quality metrics that align contracting efforts for efficiency and effectives with alternative payment models. The Program This role serves as a critical bridge between Provider Engagement, Network Performance, Analytics, Clinical and Quality Teams to drive improvement in clinical outcomes, health equity, and member and provider experience. Supervision Exercised No direct reports currently; however, one to three program consultants with future expansion. Essential Duties & Responsibilities: Provider Quality Performance and Value-Based Care Lead implementation and monitoring of quality initiatives tied to value-based payment programs and contractual performance metrics. Partner with Provider Engagement, Network, Clinical and Quality teams to evaluate provider performance, identify opportunities for improvement, and facilitate data-driven action plans. Collaborate with Contracting, Quality Analytics, and Population Health to align provider quality measures with value-based contracts and incentive programs. Translate quality performance data into actionable insights and communicate findings to provider partners to drive improvement. Support the development and oversight of provider pay-for-performance programs, including metric tracking, financial reconciliation, and performance reporting. Health Equity and CLAS Integration Partner with the Health Equity team to incorporate CLAS (Culturally and Linguistically Appropriate Services) standards into provider education and engagement activities. Lead or support the development and dissemination of provider-facing resources that advance equitable care delivery. Coordinate provider training and communication initiatives focused on social drivers of health, cultural competence, and equity-focused performance improvement. CAHPS Strategy and Performance Oversee implementation of provider-focused initiatives that support CAHPS performance improvement. Analyze CAHPS results to identify trends and collaborate with Provider Network, Clinical and Quality teams to address performance gaps. Develop and disseminate provider education and best practices to improve member satisfaction with access, communication, and care coordination. Track and report provider performance metrics related to CAHPS domains such as Getting Needed Care, Getting Care Quickly, Rating of Health Care, and Customer Service. Collaborates with Communications to design provider materials and newsletters reinforcing CAHPS-related expectations and improvement goals. Partners with network leadership to recognize high-performing providers and share improvement strategies. Provider Education and Engagement Manage the design, scheduling, and delivery of provider quality education, including webinars, learning sessions, and quality performance updates in collaboration with Quality team. Develop materials and presentations that clearly communicate quality goals, contractual expectations, and best practices to the provider network. Serve as a trusted liaison to provider partners, responding to quality-related inquiries and facilitating collaborative discussions on improvement opportunities. Performance Reporting & Data Management Partner with Quality Analytics and Business Intelligence to ensure timely, accurate, and meaningful quality performance reporting to internal teams and providers. Monitor performance trends and support the creation of dashboards, summaries, and progress reports for internal and external audiences. Maintain documentation, SOPs, and reporting schedules to support consistent quality operations. Cross-Functional Collaboration & Strategic Support Collaborate closely with Provider Engagement, Contracting, Quality, and Clinical to ensure alignment on provider quality goals. Participate in cross-functional workgroups focused on quality improvement, network performance, and member and provider experience. Support strategic initiatives that promote continuous improvement and operational efficiency across the provider network. Working Conditions Remote or hybrid working conditions. Position requires occasional travel in Massachusetts and the surrounding area. Required Education: Bachelor's degree in healthcare administration, public health, business or health care related field Desired Education: Master's degree Certified Professional in Healthcare Quality (CPHQ) or equivalent certification Required Experience: 5-7 years of experience in healthcare quality improvement, provider network performance and management, population health, or related area Demonstrated experience interpreting and applying quality measures (HEDIS, CAHPS, HOS) and value-based contract performance metrics Experience with Medicare Advantage, Medicaid; and dually eligible populations Desired Experience Experience managing or supporting pay-for-performance or value-based care programs. Experience leading provider education or training sessions. Exposure to health equity initiatives and/or CLAS standards integration in provider settings. Required Knowledge, Skills & Abilities: Strong understanding of provider quality performance frameworks and value-based care principles. Working knowledge of claims data, quality measurement, and performance incentive methodologies. Excellent verbal and written communication skills, including the ability to synthesize and present data effectively to providers and internal stakeholders. Strong relationship management and interpersonal skills; ability to engage diverse provider partners diplomatically. Proficiency with Microsoft Office Suite (Excel, PowerPoint, Word) and comfort working with dashboards and analytics tools. Proven project management skills and ability to manage multiple priorities and deadlines. Self-directed, detail-oriented, and able to work effectively in a fast-paced, matrixed environment. Desired Knowledge, Skills & Abilities: Familiarity with quality analytics platforms, provider portals, or data visualization tools. Working knowledge of health plan claims and payment policies, including provider reimbursement methodologies. Experience applying CLAS standards or health equity frameworks within provider engagement or quality improvement initiatives. Language(s) English Compensation Range/Target: $99,600 - $149,400 Commonwealth Care Alliance takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package.

Description & Requirements Maximus is currently hiring for a Quality Assurance Manager to support the Arkansas No Wrong Door project. This is a full time remote opportunity. The Quality Manager is responsible for overseeing the daily operations for the Quality Assurance team, and for creating efficient business partnerships to meet business goals. The project will be a Contact Center as Service (CCaS) that will support multiple clients throughout the state of Arkansas. *This job is contingent upon contract award.* At Maximus we offer a wide range of benefits to include: - • Competitive Compensation - Quarterly 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 sick leave, - • 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. Essential Duties and Responsibilities: - Oversee the day-to-day functions of the Quality Assurance (QA) department. - Manage an effective quality assurance program that monitors and resolves issues before they become problems. - Supervise the development and regular update of policies and procedures. - Evaluate the need for and ensure the provision of necessary training for project personnel, providing up-to-date information on relevant programs, community resources, and options for consumers. - Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements. - Provide project leadership with updates on all issues regarding quality, operations, training, and policy and procedures. - Provide leadership to all staff in the areas of quality improvement as it relates to process improvement, customer service and conflict resolution. - Prepare reports and briefings for project leadership and review monthly and quarterly project status reports provided to the Department. Minimum Requirements - Bachelor's degree in relevant field of study and 5+ years of relevant professional experience required, or equivalent combination of education and experience. - Must be willing and able to travel up to 25% of the time as business need dictates. - Lean Six Sigma experience with a minimum of Yellow Belt Certification required. - Experience managing direct reports remotely required. - Experience with designing, implementing and reporting customer satisfaction surveys required. - Experience with standardized quality tools required. - Experience with call and voice monitoring platforms required. - Experience with a large-scale telephony system required. - Experience with Client Relationship Management (CRM) platforms required. - Experience with contract compliance and quality platforms required. - Experience with statistical processes required. - Premium contact center billing experience required. - Financial experience with Oracle preferred. Home Office Requirements: - Internet speed of 20mbps or higher required (you can test this by going to ******************* - Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router. - Must currently and permanently reside in the Continental US. #max Priority 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 $ 85,000.00 Maximum Salary $ 95,000.00

**When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.** This role oversees the Program Management function for the Enterprise Data and Analytics group and works closely with the leaders in the Data and Analytics team. The individual in this role will ensure that the Data Program and all its components are operating at the top of the license. This leader is also responsible for implementing the right tools and processes for the team to enable management reporting and KPIs for the group. It will cultivate management-level partnerships to ensure key stakeholder groups are well served by the ASC/ABP function, that value is being delivered and measured, that robust relationships are being formed, and that organizational data literacy increases over time. This role requires advanced relationship-building and program management skills, with proven leadership and teamwork abilities, able to manage priorities and drive results in highly matrixed environments via the right program management and agile tools. **Job Description:** Essential Duties & Responsibilities including but not limited to: 1. Designs and executes the data program function using Agile framework. Mentors and onboard the technical teams on to the sprint cycles. 2. Helps the Analytics Business Partners in spinning up the squads as per the user stories and tracks the execution of the stories from initiation to completion. 3. Ensure status reporting both at the team level and for executive consumption. 4. Owns and oversees the governance framework related to Data and Analytics workstreams. Help Leads team in continuous automation and improvement of processes. 5. Provides assistance and collaboration to other teams, ensuring that all technologies and teams work effectively together to implement and improve products and processes. 6. Develops strong partnerships with partners and third-party vendors in developing and maintaining service level agreements, ongoing management of service level compliance, and assist in driving the support knowledge base. 7. Prioritizes projects and features, stakeholder management, and tracking of commitments. 8. Guides the team to make sound operations decisions while improving stability, reliability, and security. 9. Establishes an environment that stimulates innovation and creativity and maximizes patient and provider experience. 10. Creates and publishes project management templates, workflows and status reports for executive consumption demonstrating a clear tracking of each data streams within the Analytics functions. 11. Has the responsibility to lead and support Managers and Directors in developing and improving operations to create optimal performance levels. 12. Assists in planning, monitoring, and/or managing the budget in the functional area of the department. **Minimum Qualifications:** **Education:** + High School diploma or GED is required. A Bachelor's degree is preferred. **Experience:** + 5-8 years of related work experience is required, with 2-3 years in program management and 1 year of supervisory/management experience. + Healthcare experience **Skills, Knowledge & Abilities:** + Knowledge of Agile framework + Knowledge of product development and support + Advanced technical computer skills as required for technical support specific to function area and related systems. **Pay Range:** $135,000.00 USD - $168,000.00 USD The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. **As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment.** **More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.** **Equal Opportunity Employer/Veterans/Disabled**

At Regeneron, we are dedicated to transforming lives through science and innovation. We believe in fostering a culture of collaboration, excellence, and continuous development. We are looking for a dedicated Manager QA to join our team in Uxbridge, UK. As a key member of the Quality Assurance Distribution (QAD) team, you will play a vital role in overseeing quality operations, managing storage and distribution activities, and ensuring compliance with regulatory requirements across the UK and European markets. This is your chance to create a meaningful impact on the quality and supply of life-saving products. A Typical Day: As the Manager QA, you will: * Fulfill Responsible Person (RP) duties to ensure compliance with the Wholesale Dealers Authorisation (WDA) licence requirements. * Oversee quality operations for distributor markets and marketing authorisation holder (MAH) activities. * Manage storage and distribution activities in the UK and European markets to ensure smooth product supply. * Support inspection readiness programs for Regeneron UK and affiliates. * Author and approve quality-owned Standard Operating Procedures (SOPs) for the QAD team. * Investigate and resolve temperature excursions in the UK and global markets, implementing corrective and preventive actions (CAPAs). * Collaborate with distributor market partners to ensure effective due diligence, qualification, and relationship maintenance throughout the product life cycle. * Provide subject matter expertise and lead quality assurance initiatives for product launches into new markets. This Role May Be For You If: * You thrive in dynamic environments and enjoy managing quality operations for complex supply chains. * You have a keen eye for detail, ensuring compliance with European Good Distribution Practice (GDP) and The Human Medicines Regulations 2012. * You excel at building and maintaining effective partnerships with vendors and distributors. * You are passionate about ensuring quality and regulatory compliance in pharmaceutical distribution. * You are skilled at conducting audits, managing deviations, and implementing CAPAs. * You are motivated by opportunities to contribute to product launches and supply chain projects. To Be Considered: You must have a Life Science degree, ideally in Chemistry or Pharmaceutical Science. Experience as a named Responsible Person (RP) on a licence (preferred). You have a strong knowledge of Quality Management Systems and their application in pharmaceutical or similar industries. You are familiar with the virtual supply chain environment and management of commercial products through the supply chain. Preferred qualifications include experience in audit management, vendor/customer management programs, document control, and pharmacovigilance systems. At Regeneron, we are committed to encouraging a diverse and inclusive work environment. If you are ready to take on an impactful role in quality assurance, we encourage you to apply today! Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Job Description About Us We're more than just quality treatment for substance use disorders. We're a total health community. At SSTAR, our mission is healing the community, one person at a time. We will provide a personal level of healthcare and addiction treatment that addresses the mental, physical, and spiritual well-being of everyone we touch. SSTAR is a Federally Qualified Health Center (FQHC) which affords our employees eligibility to apply for one of our three Loan Repayment Programs, including the HRSA LRP. The Director of Quality, Compliance, and Risk requires a high degree of autonomy. This role provides oversight of all Compliance, Quality Assurance, and Risk Management initiatives. The Director investigates causes, diversions, and variations from practices. This role is responsible for the process of quality improvement efforts focusing on clinical quality, reviewing performance measures, and addressing patient complaints. In this role the Director serves as the champion of constant improvement. Benefits 403B Dental insurance Disability insurance through Massachusetts PFML Employee discounts, cell phone, eyewear etc. Health insurance Life insurance Paid time off Vision insurance Flexible Spending Account Opportunities to earn CEU's Voluntary Benefits including but not limited to, Disability, Life, Critical Illness, Accident and Disability Insurances Paid Long Term Disability Duties & Responsibilities The Director of Quality, Compliance, and Risk promotes an environment in which the healthcare team can work cooperatively toward achieving departmental and facility goals and objectives. Responsible for identifying and supporting best practices throughout the organization. The Director of Quality, Compliance, and Risk manages risk by assuring agency follows, and factually interpretates all federal, state, and local laws, rules, and regulations including CMS Conditions of Participation, BSAS, Joint Commission, and HRSA. Director prepares the agency for survey readiness by conducting survey activities and functioning as a Survey Coordinator along with other team members during surveys. Assist with the development and monitoring of corrective action plans for regulatory statements and PI improvements. The Director of Quality, Compliance, and Risk maintains quality and outcome data and uses the data to identify opportunities for improvement. Reviews all event reports and notifies management of any incidents of high-risk significance followed by an intensive investigation and preparation of a root cause analysis. The Director of Quality, Compliance, and Risk assists the CIO in the management of EHR and other data collection platforms as it applies to user compliance and quality outcomes. Responsible for the maintenance, development and monitoring of all facility-wide policies and procedures. The Director of Quality, Compliance, and Risk monitors and reports on the effectiveness of services through Performance Improvement, KPI's and other data collection methods. Promotes a planned and systematic approach to Quality with the least amount of duplication and in the most cost-efficient manner. Educates and trains Administration, Medical Staff, and employees on a full scope of PI Initiatives and their roles in performance improvement. Oversees and works collaboratively with directors on all data collection and reporting processes. Collects data, reviews, and reports all adverse incidents. Coordinates principals to gather information related to patient complaints to ensure they are resolved and prepares written responses to patients. Trends complaints and provides meaningful insight for process or procedural improvements. Coordinate and facilitate all SSTAR licensing and accreditation reviews. Reviews/advises on proposed legislative and regulatory changes. Drafts comments/responses as requested. Serves in the leadership for responding to Patient Grievances and the development of P&P. Responsible for providing meaningful feedback to departments, committees, and Medical Staff on a regular basis and timely manner. Demonstrates tact and discretion in this communication. Will assume leadership/administrative responsibility for the coordination of or participating in the preparation of grant proposals. Assists directors in the writing and updating of all policies and procedures. Functions as a liaison, ensuring cooperation and effective interdepartmental relations as it relates to QA/PI. Participates with Senior Leadership in the planning and development of programs as requested. Chairs both the Risk Management and Compliance Committees and serves on the Performance Improvement Committee. Prepares quarterly and annual Board Reports. Develop and maintain effective working relationships with outside agencies and departments. Assists CEO and Directors with oversight supervision of contracted services. Attends networking and educational opportunities for personal and organizational development. Assists the CEO with non-payer facility contracting issues including securing Business Associate Agreements. Education & Experience Bachelor's degree in Business/Healthcare Administration, Statistical Analysis, Quality Management, or related field required. Masters preferred. Healthcare Compliance Certification, preferred. Minimum of 5 years' experience in quality/process improvement with a minimum of 4 years in the healthcare or SUD treatment field. Previous quality assurance, compliance, and performance improvement experience required as well as experience working with regulatory/licensing authorities. HRSA experience preferred. Strong analytical and computer skills. Must be able to meet deadlines and manage multiple tasks adapting to shifts in priorities. Strong written and verbal skills. ANNUAL SALARY RANGE: $90,000 - $130,000

The Quality Assurance Coordinator supports the facility Compliance Program by assisting the Executive Director with the initiatives designed to adhere to the standards, regulations and requirements issued by accreditation organizations and state/federal agencies. The role also collaborates with the field and Legal department in responding to escalated medical records requests made to the Company. JOB RESPONSIBILITIES Coordinates, with assistance, key components of the Compliance Program that are designed to meet the requirements or recommendations of Federal and State regulatory agencies. Supports the field compliance team in managing the day-to-day operations of the enterprise-wide Compliance Program, including assisting with the documentation needed to accompany state licensure applications and the voluntary accreditation process. Creates reports for Compliance meetings. Develops and maintains critical organizational systems designed to meet deadlines issued by regulatory bodies, organizes key policies and procedures and responds to escalated medical record requests. Interfaces with client satisfaction survey vendor and Marketing department to develop reports to be used in Performance Improvement initiatives throughout the organization. Sort, alphabetize and scan client documents accurately in client electronic medical records. Review medical records for completeness, assemble records into standard order, and file records in designated areas according to applicable alphabetic and numeric filing systems. Review files and documents in clients' electronic medical charts for accuracy. Respond to requests for information from files according to established policies and procedures. Maintain alphabetic filing system by organizing client records on shelves to ensure records are readily accessible by all departments. Respond to inquiries from Clinical staff pertaining to medical records. Comply with federal HIPAA regulations and practice policies for the privacy and security of client information; explain the law and our privacy policy to clients as needed; maintain appropriate documentation of access to medical records. JOB QUALIFICATIONS Minimum of three (3) years of work experience in a compliance or quality assurance support role. Experience handling sensitive information with complete confidentiality. Thorough understanding of the importance of confidentiality and non-disclosure according to the general standards set forth by HIPAA. Knowledge of basic data processing procedures. Minimum 6 months medical records experience preferred. Knowledge of medical record keeping principles and practices and electronic medical records preferred. Knowledge of medical terminology, standard nomenclature and classification of diagnoses and operations preferred. Must meet pre-employment and maintain all applicable state and job-related guidelines for background screening, fingerprinting, drug testing, health screening, DMV, Insurance, CPR/Basic First Aid and license/credential verifications. Strong verbal and written communication skills. Advanced Excel skills including pivot tables and formulas. Experience maintaining policy and procedure documentation.

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. restor3d is an Equal Opportunity Employer

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Lead or assist with the Corrective Action/Preventive Action (CAPA) program. • Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including leading supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. • Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. • ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. • Demonstrated proficiency with FDA and ISO standards for Medical Devices. restor3d/ Conformis is an Equal Opportunity Employer

The Product Quality Engineer will be responsible for product quality engineering/ quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Perform quality testing of CER and Purified water system. Perform product release activities (on an as needed basis). Administers the bioburden/endotoxin testing program as required per procedure. Trend in-process manufacturing data and environmental monitoring data and produce summary reports. Implement and maintain quality system in accordance to applicable regulatory requirements. Initiate and participate in resolution of non-conforming materials. Review Non-Conformity Reports for sub-assemblies and finished goods. Administer the calibration system. Review of the daily activities for production start-up. Develop and upgrade procedures for continuous improvement as required by the quality system. Perform Internal Quality Audits of the quality system. Develop qualification/validation plans. Conduct product/process validations (sterilization). Develop and implement statistical sampling plans. Assist in the investigation of product complaints. Assist in corrective action investigations. Perform internal audits to drive continuous improvement (minimum of 2 per year). Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering or Science. 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred - with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications). Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office 2010. Knowledge of FDA and ISO standards for Medical Devices is a plus. Knowledge of Statgraphics or Minitab is a plus. Conformis is an Equal Opportunity Employer

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. Restor3d is an Equal Opportunity Employer

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Assist with the Corrective/Preventive Action (CAPA) program. • Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d/ Conformis is an Equal Opportunity Employer

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d is an Equal Opportunity Employer