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GCP Quality Assurance Auditor
Suna Solutions
Quality assurance manager job in Paramus, NJ
Now Hiring: GCP Quality Assurance Auditor
Contract Length: 11 weeks
Pay Rate: $50-$60/hr (W2)
Schedule: Hybrid. Onsite Tuesday, Wednesday, and Thursday, each week. The hours can be flexible, between 7:30am and 5pm (8 hour shift).
About the Role
We are seeking a highly motivated GCP Quality Assurance Auditor to join our growing biopharmaceutical team focused on Neurology and Psychiatry therapies. Reporting to the Director of GCP/PVG Quality Assurance, you will play a key role in ensuring GXP compliance, implementing compliance initiatives, and supporting quality management systems across clinical operations, non-clinical, and manufacturing.
This position involves conducting both internal and external GXP audits, managing relationships with CROs, CMOs, investigator sites, and vendors, and supporting the organization in maintaining the highest quality standards. This is an onsite position in Northern New Jersey.
Key Responsibilities
Plan and conduct scheduled global clinical process and vendor audits across all clinical trials.
Conduct risk-based audits of specific clinical processes.
Perform clinical vendor audits alongside SMEs (e.g., IRT, EDC) to evaluate vendor services.
Prepare audit reports and distribute to relevant stakeholders.
Manage vendor non-conformances and follow up on corrective actions.
Review and apply clinical regulations and guidelines (FDA regulations, GCP, etc.).
Collaborate with clinical sourcing, supplier quality, and clinical teams to manage vendor performance.
Support regulatory inspections and participate in quality improvement projects.
Qualifications
Must have 2+ years of experience in radiopharmaceuticals and quality assurance.
Bachelor's degree in a scientific, healthcare, or related discipline.
Extensive knowledge of GCP and safety standards.
Experience conducting internal and external process and system audits.
Strong understanding of development policies, procedures, and SOPs/QMS.
Ability to work with global clinical teams to define audit objectives.
Willingness to travel up to 10%.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:
Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMODATION
Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at ****************, send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT
Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.
$50-60 hourly 3d ago
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Assurance Manager - Financial Services
Eisneramper 4.8
Quality assurance manager job in Melville, NY
At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact. Whether you're starting out in your career or taking your next step as a seasoned professional, the EisnerAmper experience is one-of-a-kind. You can design a career you'll love from top to bottom - we give you the tools you need to succeed and the autonomy to reach your goals.
We are seeking an Audit Manager to join the Financial Services Audit practice, able to sit in a number of our offices. We are seeking someone who thrives in a growing environment and providing clients with exceptional services.
What it Means to Work for EisnerAmper:
You will get to be part of one of the largest and fastest growing accounting and advisory firms in the industry
You will have the flexibility to manage your days in support of our commitment to work/life balance
You will join a culture that has received multiple top "Places to Work" awards
We believe that great work is accomplished when cultures, ideas and experiences come together to create new solutions
We understand that embracing our differences is what unites us as a team and strengthens our foundation
Showing up authentically is how we, both as professionals and a Firm, find inspiration to do our best work
What Work You Will be Responsible For:
Collaborate to plan audit objectives and determine an audit strategy
Lead multiple audit engagements and competing priorities
Review and examine, and analyze accounting records, financial statements, and other financial reports to assess accuracy, completeness, and conformance to reporting and procedural standards
Maintain active communication with clients to manage expectations, ensure satisfaction, and lead change efforts effectively
Understand and manage firm risk on audits and proposals
Supervise, train and mentor staff during engagement
Assess performance of staff for engagement evaluations
Basic Qualifications:
Bachelor's degree in Accounting or equivalent field
5+ years of progressive audit and/or assurance experience
CPA
Experience with asset management clients
Preferred/Desired Qualifications:
Master's degree in Accounting or equivalent field
1+ year of supervisory experience
EisnerAmper is proud to be a merit-based employer. We do not discriminate on the basis of veteran or disability status or any protected characteristics under federal, state, or local law
About Our Audit Team:
In the EisnerAmper Audit Group, we're transforming the traditional reputation of auditing. By operating on the core tenets of profound trust, professional integrity, and consistent results, we strive to create lasting partnerships with our clients based on solutions rather than simply identifying issues in their financial statements.
To stay up to date with evolving industry processes and regulations, we place a heavy emphasis on continued education and the consistent adoption of new technologies. This enables us to effectively innovate, grow as individuals, and provide faster, more accurate solutions and due diligence for our partners.
Acting as a trusted third party to our clients, we provide solutions that create assurance and peace of mind. Because we understand trust comes with time, we define success by the relationships we create and foster. We act as a trusted business advisor every step of the way, from a client's first financial report to their close of business.
About EisnerAmper:
EisnerAmper is one of the largest accounting, tax, and business advisory firms, with nearly 4,000 employees and more than 350 partners across the world. We combine responsiveness with a long-range perspective; to help clients meet the pressing issues they face today and position them for success tomorrow.
Our clients are enterprises as diverse as sophisticated financial institutions and start-ups, global public firms, and middle-market companies, as well as high net worth individuals, family offices, not-for-profit organizations, and entrepreneurial ventures across a variety of industries. We are also engaged by the attorneys, financial professionals, bankers, and investors who serve these clients.
Should you need any accommodations to complete this application please email:
For Minnesota, the expected salary range for this position is between $112,000 - $121,000 USD Annual. The range for the position in other geographies may vary based on market differences. The actual compensation will be determined based on experience and other factors permitted by law.
#LI-MC1
#LI-Hybrid
Preferred Location:New York
For NYC and California, the expected salary range for this position is between
85000
and
150000
The range for the position in other geographies may vary based on market differences.The actual compensation will be determined based on experience and other factors permitted by law.
$112k-121k yearly 5d ago
Director of Quality
Joseph P. Addabbo Family Health Center, Inc. 4.7
Quality assurance manager job in Malverne, NY
The Director of Quality is responsible for developing, implementing, and maintaining a comprehensive quality improvement (QI) and performance management program for the Federally Qualified Health Center (FQHC). This role ensures compliance with HRSA requirements, NCQA Patient-Centered Medical Home (PCMH) standards, UDS reporting, and other regulatory or accreditation bodies, while fostering a culture of continuous improvement in clinical, operational, and patient experience outcomes.
RESPONSIBILITIES:
Directly supervises the Quality Coordinators.
Develops Quality Assurance policies to ensure successful implementation of improvement standards.
Serves as the primary liaison between JPA and Managed Care Organizations (MCOs), representing the organization in all quality-related engagements and ensuring active participation in MCO quality meetings. Assesses patient medical records to ensure compliance with established quality standards.
Coordinates and ensures timely completion of the quarterly provider peer review cycle.
Conduct on-site visits to monitor and assess the implementation of QA/QI activities, including pre-visit planning and daily huddles.
Aggregates statistical quality assurance data, develops comprehensive narrative reports, and partners with clinical informatics specialists to support data-driven improvements.
Collaborates with the CMO to revise the Quality Assurance and Utilization Review plan in accordance with HRSA guidelines.
Coordinates recurring QI/QA meetings with the Quality Coordinators and Department Leads, manages meeting coordination, records minutes, tracks participation, and ensures timely follow-up on all assigned tasks and activities.
Monitor and track performance on HEDIS and other quality measures across payer contracts.
Identify and prioritize care gaps in collaboration with clinical and operational teams.
Develop and implement strategies to close care gaps, including outreach campaigns, provider engagement, and patient education.
Collaborate with clinical teams, payors, and population health staff to align quality improvement efforts with value-based care goals. Maintain up-to-date knowledge of CMS, NCQA, and payer-specific quality measure requirements.
Assist in the reporting and analysis of quality metrics to identify trends, disparities, and opportunities for improvement.
Coordinate with IT and analytics teams to ensure accurate and timely data capture and reporting.
Support the preparation of documentation and evidence for HEDIS audits and external reviews.
Contribute to quality improvement initiatives, such as PDSA cycles, root cause analyses, and performance dashboards.
May be required to perform other duties as assigned or when necessary.
QUALIFICATIONS:
Education:
Bachelor's degree in healthcare administration, public health, Nursing, or related field required.
Master's degree in public health, Healthcare Administration, or related field preferred.
A licensed Registered Nurse (RN) or Nurse Practitioner (NP) with a strong background in healthcare quality improvement will also be considered in lieu of a master's degree.
Experience:
Minimum 5 years of progressively responsible experience in healthcare quality or performance improvement, preferably in a community health center or FQHC setting.
Strong working knowledge of HRSA, UDS, NCQA PCMH, and related regulatory requirements.
Skills:
Demonstrated ability to lead quality initiatives and manage cross-functional teams.
Proficiency in data analysis and quality improvement tools (e.g., Excel, EHR reporting, QI methodologies). Excellent verbal and written communication skills.
Experience with risk management, clinical compliance, and patient safety programs is a plus.
Working Conditions:
Primarily office-based with some travel between clinical sites.
May require occasional evenings or weekends for meetings or training.
Why Join Us: Be part of a mission-driven organization focused on improving patient outcomes and advancing health equity. Collaborate with cross-functional teams to shape the future of value-based care. Opportunities for growth and professional development in a dynamic healthcare environment.
We are seeking an experienced GCP Quality Assurance Auditor to join our rapidly growing biopharmaceutical company specializing in neurology and psychiatry therapies. This role ensures GXP compliance, drives quality management initiatives, and conducts internal and external audits across clinical trials, safety/pharmacovigilance, and vendor operations (CROs, CMOs, investigator sites).
The ideal candidate has extensive GCP experience, a strong pharmaceutical QA background, and expertise in radiopharmaceuticals. This is an on-site position in Northern NJ with flexible hours and minimal domestic travel.
Key Responsibilities:
Plan and perform global clinical process and vendor audits across all clinical trials
Conduct risk-based audits of clinical processes and vendors, including IRT and EDC systems
Prepare detailed audit reports and manage related non-conformances
Ensure compliance with GCP, FDA, EMA, and ICH regulations
Support regulatory inspections and quality improvement initiatives
Collaborate with clinical teams, QA, and vendor management
Qualifications:
Bachelor's degree in a scientific, healthcare, or related discipline
5+ years of pharmaceutical industry experience, including 2+ years in radiopharmaceutical QA
Extensive GCP and safety/pharmacovigilance experience
Proven experience in internal and external GXP audits
Familiarity with QMS, SOPs, clinical systems (IRT, EDC), and regulatory documentation
Strong communication and cross-functional collaboration skills
Up to 10% domestic travel
Why Join Us:
Be part of a fast-growing biopharma company making a difference in neurology and psychiatry
Hybrid work schedule with flexible hours
Opportunity for extension or full-time role
$68k-110k yearly est. 13d ago
Food Safety Quality Assurance Manager
Schweid & Sons 4.0
Quality assurance manager job in Carlstadt, NJ
Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing.
Summary :
This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3rd party sanitation.
Essential Job Functions :
Food Safety / Regulatory
Managing implementation of the HACCP Plan, its associated documents and including reassessments
Maintaining records in accordance to the policy / HACCP program
Conduct plant GMP inspections and monitor GMP's for compliance
Responsible for maintaining the company's compliance with FSIS regulations.
Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products.
Oversee training program for GMP's, HACCP and Food Defense/Food Fraud.
Respond to non-compliance reports issued by FSIS.
Manage the 3rd party Sanitation program for the facility.
Quality / Customer Service
Lead 3rd party audits (SQF / Customer Specific) and Customer tours including CAPA's.
Strive for continuous improvements of products, process, procedures, and reliability.
Maintain data of customer requirements, quality specifications and reporting requirements.
Manage quality training program.
Ensure specification compliance for raw materials and finished products.
Managing implementation of quality programs.
Assist with product development and special projects associated with product development.
Respond to customer complaints with CAPA's / letters as needed.
Establish the raw material and finished product shelf life.
Other
Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor
Manage the department to meet budget.
Other tasks and projects may be assigned.
10 - 20% travel required
Minimum Requirements :
Red Meat Experience a Must
Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred.
5 plus years' experience working in the Food Industry in a leadership role.
HACCP Knowledge and Experience
SQF / BRC Knowledge and Experience
Ability to think independently and take responsibility for decisions.
What We Offer
The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process.
Time Off: PTO, Safe & Sick Time, and Paid Holidays.
Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits.
Financial Benefits: 401(k) + employer match and life insurance.
Location: This is an on-site role located in Carlstadt, NJ .
Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.
$100k-130k yearly Auto-Apply 60d+ ago
Director, Clinical Quality Assurance
Eisai 4.8
Quality assurance manager job in Nutley, NJ
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 :195,000-256,000Under 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
$109k-151k yearly est. Auto-Apply 60d+ ago
SAP QA Manager
Cygnus Professionals 3.2
Quality assurance manager job in Hoboken, NJ
Headquartered in New Jersey (U.S), Cygnus Professionals Inc. is a next generation global information technology Solution and Consulting company powered by strong management and leadership team with over 30 person years of experience. Today, Cygnus has strong footprints in more than 4 countries with more than 25 satisfied customers. We strive to extend our presence across industries and geographies with our industry-focused business excellence.
Cygnus Professionals Inc. has been named by the US Pan Asian American Chamber of Commerce Education Foundation (USPAACC) as one of the “Fast 100 Asian American Businesses” - joining the country's fastest-growing Asian American-owned companies, based on percentage revenue growth over the immediate past two years.
Job Description
Role: SAP QA Manager
Location: Hoboken, NJ
Duration: 6 Months Contract (will continually extend)
Mode of Interview: Face To Face After Phone
!! Need Green Card OR US Citizen Candidates Only !!
Requirements:
• Must have at least 10 years working experience leading QA teams
• Must have 5+ years Performance Testing working experience
• Must have 5+ years leading managed service teams
• Profound knowledge and significant experience with structured risk-based testing
• Experience in managing on-site and off-shore geographically distributed teams
• Good knowledge of test management and issues tracking systems
• Periodic status reports on test progress for the projects adopted for QA testing.
• Ability to set high standards and stick by them
• Strong skills in critical thinking and analysis
• Meeting facilitation
• Verbal and written communications
• Good organizational skills
• BS in Computer science or related field, Masters' degree preferred
• Must be willing to travel as required
•
o Experience with SAP
o Develop and implement testing strategy
o Define and manage the development of key testing deliverables
o Lead analysis and reporting of testing results
o Manage the tracking and resolution of risks and issues
o Manage coordination of testing resources to support test cycles
o Lead test tool setup and administration
o Manage key testing deliverables and architecture
o Escalate issues as required to SVP & ERP Program Lead
o Experience with Rational Quality Manager
o Experience with JIRA for defect tracking
o International experience
o Experience with heavy integration testing
Qualifications
Desired Experience:
• Familiarity with publishing (including Web publishing) industry
• Requirements management, test management, and issues tracking tool from at least one manufacturer:
- IBM Rational
- HP
• Experience leading teams in large managed services teams
• Experience delivering solution in a fast paced dynamic environment
• A background in testing of web-based and mainframes
• Good knowledge of standard industry metrics
Additional Information
** U.S. Citizens and those who are authorized to work independently in the United States are encouraged to apply. We are unable to sponsor at this time.
** All your information will be kept confidential according to EEO guidelines.
$98k-132k yearly est. 60d+ ago
Director of Quality Improvement
Opengate 3.5
Quality assurance manager job in Armonk, NY
The Director of Quality Improvement is responsible for ensuring that Opengate's programs conform to all federal and state regulations and that all agency policies and procedures are adhered to. The Director of Quality Improvement develops and implements Opengate's QI plan, inclusive of scheduled internal audits of each department.
Essential Job Functions:
Ensures the agency maintains a comprehensive Quality Improvement Plan that is reviewed and updated quarterly, or as needed, to meet regulatory standards and support the agency's mission and goals for providing quality services.
Develops and implements quality improvement systems across the agency.
Complete internal audits to establish trends or patterns for monitoring and ensuring timely documented completion and implementation of plans of corrective action for internal reviews.
Completes routine scheduled observations of program functions, systems and provides follow up. This includes on-site visits of all program areas for evaluation of program and service delivery.
Meets with department directors, coordinators and managers to share information and make recommendations.
Provides feedback and training recommendations to management and direct support staff.
Attend all external surveys/audits, act as agency liaison with external auditors, and ensure timely responses to POCAs.
Review statements of deficiency and Exit Conference Forms and completes Plans of Correction Action with input from applicable departments/staff.
Collaborate with program administrators to ensure compliance with applicable Federal, State and local regulations and agency policies.
Assist the Chief Compliance Officer in developing trends reports.
Acts as CAS liaison and oversees the coordination of CAS Assessments for anyone receiving services or supports through Opengate.
Assist with the identification of agency training needs resulting from OPWDD, DOH, OFPC, and OMIG regulatory requirements, changes in regulations, deficiencies or internal quality reviews.
Participates on the agency Corporate Compliance Committee as requested.
Must be able to interact/coordinate with OPWDD, OFPC, OMIG, DOH, and other community partners as necessary.
Ensure agency liability notices and updates are distributed and collected upon intake and as needed thereafter.
Identifies, responds to and addresses resident, participant or advocate dissatisfaction with services.
Follows federal, state and local governmental regulatory guidelines pertaining to a safe, healthy and clean work environment, reporting health and safety concerns to the supervisor.
Other duties as assigned by the CCO.
Qualifications:
A bachelor's degree in health, human services, education or management. Master's degree preferred.
Five (5) years of experience working with ID/DD population in an OPWDD setting.
Extensive knowledge of state and federal regulations as they pertain to OPWDD service providers.
Must have excellent interpersonal skills and the ability to interact well with people receiving supports, employees, and external regulatory agencies and stakeholders.
Must have excellent writing, computer, time management, and organization skills.
Physical Requirements:
Ability to work in a professional office environment for extended periods of time, routinely using standard office equipment.
Ability to lift, push and pull up to 50 pounds, as well as bend, kneel and crouch as needed.
Salary: $75,000 - $85,000
Compensation will be commensurate with job qualifications and work experience.
Opengate is committed to equal employment opportunity. We will not discriminate against employees or applicants for em
ployment on any legally-recognized basis including, but not limited to: veteran status, uniform service member status, race, color, religion, sex, national origin, age, physical or mental disability, creed, national origin, ancestry, age, marital status, domestic or civil union partnership status, affectional or sexual orientation, gender identity, genetic information, transgender status, predisposing genetic characteristics, familial status, education, domestic violence victim status, or any other characteristic protected under federal, state, or local law. The Company promotes inclusion and acceptance of all protected classes.
In order to promote and maintain a community culture, employees hired to work at Opengate must legally reside and perform their work in the state of New York, New Jersey, Connecticut, or Pennsylvania.
$75k-85k yearly Auto-Apply 30d ago
QA Automation Testing Manager
Tata Consulting Services 4.3
Quality assurance manager job in Stamford, CT
Must Have Technical/Functional Skills We're seeking a QA Automation Testing Manager (SDET) with 10+ years leading multiteam QA programs, to drive engineering-quality practices across complex banking platforms and integrations. You will architect automation frameworks, embed quality into CI/CD, and lead a team of SDETs/QA engineers to deliver reliable, compliant releases at speed. Experience in BFSI systems (core banking, payments, digital channels) and hands-on coding for test automation is essential.
Job description
* Automation Architecture & Delivery
* Design, implement, and scale UI/API/DB automation frameworks (Selenium java/UFT, RestAssured/Postman, Cucumber/BDD, TestNG/JUnit).
* Integrate automated suites into CI/CD (Azure DevOps/Jenkins/GitLab) with quality gates, parallelization, test impact analysis, and artifact publishing.
* Establish coding standards for test harnesses, mocks, data builders, and service virtualization; enforce code reviews and static analysis for test code.
Domain‑Focused Testing (Banking)
* Translate banking use cases (core deposits/loans, ACH/wires, card/payments, digital banking) into robust automated scenarios and data validations.
* Partner with product owners and vendor teams (e.g., Fiserv, internal platforms) to triage defects, validate patches/hotfixes, and maintain regression beds.
Program Leadership & Governance
* Lead a squad of SDETs/QA engineers-capacity planning, mentoring, and upskilling on advanced automation topics.
* Orchestrate defect triage, root‑cause analysis, and risk‑based test planning; own release readiness (go/no‑go) and rollback validation.
* Drive shift‑left practices (contract testing, API first, early data checks) and shift‑right observability (synthetic monitoring, production validation dashboards).
* Compliance & Security
* Ensure test evidence meets BFSI regulatory/audit needs (SOX); automate traceability from user stories to test results and logs.
Required Qualifications
* 10-12+ years in software testing/quality engineering, with 5+ years leading SDET/automation teams.
* Strong hands‑on coding in Java/C# (or equivalent) for test automation (frameworks, utilities, custom drivers).
* Proven delivery of CI/CD‑integrated automation at scale; expert in test design for microservices, REST APIs, and event‑driven systems.
* BFSI domain experience-core banking or payments-and vendor/platform collaboration (e.g., Fiserv) for patch/regression cycles.
* Solid grasp of SQL and data validation; familiarity with logs/metrics (Splunk/Sumo/Grafana) for test diagnostics.
Preferred Skills
* Experience with OSAT‑style regression accelerators or similar enterprise frameworks; comfortable with shift‑left/shift‑right test strategies.
* Performance testing (JMeter/LoadRunner)
* ISTQB (Advanced), Agile/SAFe, or cloud certifications (Azure/AWS).
Generic Managerial Skills, If any
* Tools & Stack (Illustrative)
* Automation: Selenium, Cypress, Playwright, RestAssured, Postman, Cucumber/BDD, Appium (mobile)
* CI/CD & SCM: Azure DevOps, Jenkins, GitLab, GitHub Actions; Git
* Test Management : Azure Test Plans, ALM/Octane, Zephyr/Xray
* Data/DB: SQL Server, Oracle, PostgreSQL; TDM/masking tools
* Observability: Splunk/Sumo, Grafana/Prometheus; quality dashboards
Education
Bachelor's in computer science/engineering or related field (advanced degree a plus).
TCS Employee Benefits Summary:
* Discretionary Annual Incentive.
* Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
* Family Support: Maternal & Parental Leaves.
* Insurance Options: Auto & Home Insurance, Identity Theft Protection.
* Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement.
* Time Off: Vacation, Time Off, Sick Leave & Holidays.
* Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
Salary Range : $100,000-$120,000 a year
$100k-120k yearly 13d ago
Precision Manufacturing Process and Quality Manager
Spectrum Comm 4.2
Quality assurance manager job in Farmingdale, NY
Superior Motion Controls designs, produces and delivers precision components and assemblies for defense and aerospace systems. We are seeking a highly experienced and hands-on Process and Quality Manager to oversee all aspects of our Quality Program including design and development, precision machining, assembly and test of electromechanical assemblies. This role is responsible for supervising and scheduling internal inspection personnel and interfacing with engineering and production management to ensure all work products (WIP and final components) meet requirements. The Process and Quality Manager will serve as the principal adviser to executive management on elements of the company's Quality Management System and directly lead the company's efforts to maintain all required certifications with respect to external standards (ISO9001:2015, AS9100, etc.).
Key Responsibilities
▪ Oversee all aspects of the company's Quality Program and the Inspection Department.
▪ Supervise and schedule the activities of all company quality inspectors
▪ Recruit and train Quality Inspectors to ensure adequate staffing to meet demand
▪ Achieve and maintain proficiency as a Quality Inspector
▪ Ensure all inspection tools and systems are calibrated on schedule as required and maintain appropriate documentation.
▪ Lead the Company through all required external quality audits (Standards based such as ISO 9001, AS9100 as well as any customer required)
Requirements
Qualifications
▪ Minimum 10 years experience in quality control, with at least 5 years in a leadership or management capacity; preferably in a precision machining/manufacturing environment
▪ Ability to read and interpret complex engineering drawings and GD&T
▪ Strong skills in coaching and developing inspectors with a range of experience levels
▪ Familiarity with lean manufacturing principles, ERP systems, and performance metrics
▪ Effective communicator with strong collaboration skills across departments
$125k-192k yearly est. Auto-Apply 58d ago
Manager, Plant Quality
Voyant Beauty 4.2
Quality assurance manager job in Ridgefield, NJ
Voyant Beauty believes our people are more than just employees; they're the driving force behind everything we achieve. Our culture fosters teamwork, respect, and camaraderie, ensuring that every individual's contribution is valued and celebrated. We invest in their growth, providing opportunities for development and advancement within our dynamic team.
Voyant Beauty is a company that specializes in the development and manufacturing, of beauty, personal and home care products. We work with various brands, retailers, and businesses to create customer formulations and products tailored to their needs. This can include skincare, haircare, bath and body products, fragrances, and more. Essentially, Voyant Beauty serves as a one-stop-shop for companies looking to bring their beauty and personal care product ideas to life.
Safety is a core value at Voyant Beauty. We prioritize the well-being of our team members, ensuring a safe and secure environment where everyone can thrive and excel.
If you're seeking to be part of a team where your talents are valued, your safety is paramount, and your efforts contribute to meaningful change, then Voyant Beauty is the place for you. Come join us and be a part of our journey.
A Brief OverviewThe Plant Quality Manager provides strategic and operational leadership for all quality functions at a high-volume OTC manufacturing facility. This role ensures GMP compliance, drives a quality culture, and leads quality system improvements to enhance overall site performance. As a critical leader, the Plant Quality Manager will strengthen the Quality organization, foster quality culture transformation, and optimize operational excellence across the facility. The ideal candidate is a hands-on, technically proficient leader with cGMP knowledge (21 CFR 210/211) and the ability to align cross-functional teams to elevate the site's quality systems and compliance.What you will do
Lead QA, QC Labs, Document Control, Validation, and Complaint Management operations.
Oversee implementation and improvement of site QMS in line with FDA and corporate standards.
Serve as quality site lead for FDA and customer inspections. Ensures inspection readiness at all times.
Address compliance issues and manage CAPAs effectively.
Promote accountability, data integrity, and a right-first-time mindset.
Collaborate with Ops, Eng, R&D, etc., on investigations, change management, validations, and continuous improvement.
Supervise review of batch records, product release, deviations, and investigations.
Work with customers, and other stakeholders to meet compliance expectations.
Analyze metrics to drive performance and quality improvement.
Coach and develop a High Performing Team. Ensure effective resourcing of quality teams.
Represent site quality leadership in executive meetings.
Contribute to corporate quality strategy alignment.
Participate in strategic planning and facility expansion discussions.
Some duties may vary slightly by location.
Education Qualifications
Bachelor's Degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or similar. (Preferred)
advanced degree (Preferred)
Experience Qualifications
10+ years in FDA-regulated OTC, pharmaceutical, or personal care environments. (Preferred)
10+ years managing FDA inspections and remediation efforts. (Preferred)
10+ years background in aerosol manufacturing and topical formulations is a plus. (Preferred)
Skills and Abilities
Expertise in cGMPs, 21 CFR 210/211, ICH, USP (High proficiency)
Leading FDA/customer audits and inspection readiness (High proficiency)
Remediation planning and effectiveness verification (High proficiency)
Working with Ops, Eng, and R&D on QMS topics (High proficiency)
Team coaching, mentoring, and resourcing (High proficiency)
Effective internal/external stakeholder communication (High proficiency)
ERP (e.g., SAP), LIMS (e.g., MasterControl), TrackWise (High proficiency)
Driving transformation in quality mindset and execution (High proficiency)
Licenses and Certifications
ASQ Certification (Preferred)
Lean Six Sigma or OpEx training (Preferred)
To Staffing and Recruiting Agencies:Our company does not accept unsolicited curriculum vitae's or applications from agencies. We are not responsible for any fees related to unsolicited curriculum vitae's or applications and explicitly reserve its right to contact candidates presented in such unsolicited curriculum vitae's or application.
Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, color, national origin, sexual orientation, age, disability or veteran status. Voyant Beauty will consider requests for accommodations due to a disability impacting a qualified employee's ability to perform the essential functions of their position consistent with applicable laws. In addition to federal law requirements, Voyant Beauty complies with applicable provincial 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.
$81k-101k yearly est. 60d+ ago
QC Manager, Training & Compliance
Lynkx Staffing LLC
Quality assurance manager job in Saddle Brook, NJ
Quality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues.
Develop and maintain training program within Quality Control which includes, onboarding and continuous training
Manage deviations, CAPAs, change controls and document review to ensure compliance
Ensure OOS investigations are completed adequately.
Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories
Identify resources needed for training and compliance and build team accordingly
Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements.
Monitor effectiveness of CAPAs, change control activities, and audit observation closure.
Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions.
REQUIREMENTS
BA/BS/MS in a science or relevant field required
Prior cGMP experience required
Prior QC laboratory experience in a cGMP environment a must
3-5 years' experience in the pharmaceutical, biologics ore related industry
Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position
Sound understanding of cGMPs
Experience in laboratory training and compliance
External laboratory management experience
Strong knowledge of testing methodologies, philosophies, method validation and method transfers.
Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review
Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner
Experience with laboratory training programs
Knowledge of GMP requirements
Excellent organizational and leadership skills
Outstanding analytical problem-solving abilities
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
$70k-103k yearly est. 26d ago
Supplier Quality Manager
MWI Animal Health
Quality assurance manager job in New Hyde Park, NY
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
The Supplier Quality Manager is responsible for ensuring suppliers meet World Courier quality standards and compliance requirements while driving continuous improvement in supplier performance. This role involves developing and maintaining supplier quality programs, conducting audits, and managing supplier relationships to ensure the delivery of high-quality materials and services. The Supplier Quality Manager collaborates across departments to align supplier performance with organizational goals and regulatory standards.
Primary Duties and Responsibilities:
Supplier Quality Program Development
Develop and implement supplier quality management policies, procedures, and standards.
Partner with global QA to establish and maintain supplier qualification and approval processes.
Define key performance indicators (KPIs) to monitor supplier quality and performance.
Supplier Audits and Assessments
Conduct regular supplier audits to ensure compliance with quality standards, regulatory requirements, and company specifications.
Perform risk assessments for suppliers and identify opportunities for improvement.
Prepare audit reports, corrective actions, and follow-up plans for supplier quality issues.
Supplier Relationship Management
Build strong relationships with suppliers to foster collaboration and alignment.
Communicate quality expectations clearly and provide feedback to suppliers on performance.
Work closely with suppliers to implement corrective actions and resolve quality issues.
Quality Issue Resolution
Investigate supplier-related quality issues and implement root cause analysis to prevent recurrence.
Collaborate with internal teams to address and resolve supplier-related challenges.
Ensure timely resolution of non-conformance reports (CAPA) and deviations.
Compliance and Regulatory Standards
Ensure suppliers comply with industry standards, regulatory requirements, and certifications (e.g., TSA, GDP).
Maintain supplier quality documentation in accordance with company and regulatory standards.
Stay updated on changing regulations and ensure supplier compliance.
Continuous Improvement Initiatives
Drive continuous improvement efforts across the supplier base to enhance quality, efficiency, and cost-effectiveness.
Partner with internal supplier management teams to reduce lead time and improve operational efficiency.
Implement best practices for supplier quality management.
Required Qualifications:
Bachelor's degree in Engineering, Quality Management, Supply Chain Management, or a related field.
Minimum of 5 years of experience in supplier quality management, quality assurance, or a similar role.
Strong knowledge of quality management systems (e.g., ISO 9001, GDP).
Experience with supplier audits, corrective actions, and root cause analysis.
Proficiency in quality tools and methodologies (e.g., Six Sigma, Lean Manufacturing, FMEA, SPC).
Knowledge of regulatory requirements such as FDA, EMA, or other relevant standards.
Skills and Competencies:
Excellent analytical and problem-solving skills.
Strong project management and organizational abilities.
Effective communication and interpersonal skills to collaborate with suppliers and cross-functional teams.
Ability to negotiate and influence supplier performance.
Proficient in quality management software and tools.
Preferred Qualifications:
Certifications such as ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or similar.
Experience in pharmaceutical, medical device, or highly regulated industries.
Familiarity with ERP systems and supply chain management software.
Work Environment:
Office-based with occasional travel to supplier facilities (estimated travel time 40%).
Must be able to travel overseas if required.
Requires working in cross-functional teams and engaging with suppliers globally.
Having a high sense of dedication and collaboration to support quality department's initiatives and moving quality excellence forward.
Detailed, well-organized and able to multi-task and manage multiple projects at the same time, prioritizing required actions accordingly to meet required deadlines.
Strong drive to remain focused, self-motivated and committed to completing or achieving tasks.
Be open minded to industry/organizations change and learn/adopt new skills/knowledge/tools to drive success.
Excellent skills in Microsoft Office (Excel, Word and PowerPoint).
Able to work independently and lead a team when required.
What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit **************************************
Full time Salary Range*$57,900 - 85,360
*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
.
Affiliated Companies:Affiliated Companies: World Courier Inc
$57.9k-85.4k yearly Auto-Apply 29d ago
QA Coordinator (Korean Bilingual)
Bluu, Inc.
Quality assurance manager job in Hackensack, NJ
Location: Hackensack, NJ Employment Type: Full-time About the Role: We are seeking a detail-oriented and motivated QA Coordinator to join our team. The ideal candidate will be responsible for creating, documenting, and executing system test plans and test scripts, as well as validating data and analyzing test results. This role involves identifying, reporting, and tracking software issues, and communicating findings and progress updates with our software development team in Korea.
Key Responsibilities:
Develop, document, and execute comprehensive system test plans and test scripts.
Perform data validation and analyze test results to ensure software quality.
Record, report, track, and retest bugs found during testing.
Collaborate and communicate effectively with software developers in Korea to resolve issues.
Support continuous improvement of testing processes and documentation.
Qualifications:
Bachelor's degree in Computer Science or a related field.
Bilingual proficiency in Korean and English (both written and verbal).
1-2 years of experience in system testing of Windows-based Point of Sales (POS) software.
Hands-on experience with PC POS peripherals such as printers, barcode scanners, customer displays (CDP), and dot matrix printers.
Strong analytical, problem-solving, and communication skills.
High attention to detail and ability to work in a fast-paced environment.
Benefits:
Group Health Insurance (Medical, Dental, Vision)
Employer paid Life Insurance
Paid Sick and Vacation
401K with 3% matching
Gym Reimbursement
Company Lunch
Please visit our website ************* for more information
$51k-76k yearly est. Auto-Apply 60d+ ago
Quality Assurance Coordinator
Harvest Hill Beverage Company 4.3
Quality assurance manager job in Stamford, CT
*This role is geared toward an entry level candidate (i.e. recent college graduate who possesses 1-3 years of professional work experience)
About Harvest Hill:
Harvest Hill Beverage Company is one of the nation's largest independent branded beverage producers, delivering consistent annual revenue growth, with sales of over $1 billion. The company was formed in June 2014 with the acquisition of Juicy Juice and further expanded with 3 subsequent acquisitions which were consolidated into one company in May 2017. Our portfolio of iconic brands includes Juicy Juice , SunnyD , Veryfine , Fruit2O , Little HUG , Daily's Cocktails , and Nutrament . We manufacture, market, and distribute across multi-channels including Grocery, Mass Merchandisers, Warehouse Clubs, Convenience, Foodservice, and Liquor Distributors.
Harvest Hill is headquartered in Stamford, CT with a nationwide network of manufacturing and distribution facilities, employing over 1,000 employees in the United States. For more information visit harvesthill.com.
Position Summary:
The QA Coordinator posts files to appropriate internal/external sites and ensures corresponding databases are maintained and up to date. Creates, maintains and ensures all internal HHBC finished product quality documentation is current, accurate and project timelines for the QA team are maintained. The QA Coordinator creates updates & sustains Customer Portal and program documentation; carries out follow-up activities with customers and generates finished product standards as necessary. Directly assist in customer, consumer and field complaint support activities.
Primary Position Responsibilities:
• Maintain and update internal/external databases (TraceGains/Repositrak/Others) with customer documentation through active engagement in customer portal processes. Generate monthly reports defining completeness, gaps and goals.
• Preserve the Harvest Hill customer list identifying products and manufacturing locations with a routine engagement of the gap assessment and resolution activities.
• Efficiently coordinate the tracking of consumer, customer and field complaints with weekly reports.
• Issue ongoing consumer investigation requests and maintain logs with timeline completion rates. Follow-up with sites on investigations. Support QA Mgr in trends and Complaint rates by categories.
• Assists QA Mgr in developing concise feedback on status of field CAPA's and associated timelines.
• Supports retrieval of technical details in the development of external and internal technical specifications for finished goods. Meanwhile adhering to HH, FDA, State and Local Regulations and Co-Manufacturing Alliance agreements.
• Update and sustain Customer Portal with appropriate program documentation. Ensure through management engagement that customers receive the correct and accurate information. (no more no less). Foster meetings and communication with sales, customer service and QA to ensure accuracy.
• Illustrate QA meetings as assigned, document activities and initiate follow-up.
• Manage the receipt of new products, trial samples, consumer complaints that are delivered to the CT office. Track and photo packages received, identify location to store and act on disposal as required. Reach out to Sr Director or QA Mgr for direction.
• Generate quarterly project timelines for the QA department corporate team.
• Analyze & support QA Mgr in recommended next steps as it relates to handling and transportation deficiencies of finished goods.
• AX acumen for the HHBC QA team. Within the first 180 days, train on AX, develop tutorials and train all members of our CT staff.
• Review all co manufacturer requests for destruction of surplus, expired or defunct finished goods.
• As a back-up to cross-functional QA team, learn documentation OOSR, ATS, shelf-life update process.
• Support Co-Man and DC Trace exercises which occur a few times a year.
• Support product manual upkeep with direct supervision by Head of FSQA.
• Additional duties that may be assigned.
Position Qualifications:
• Candidate should possess a BS/BA degree in science, project management or related field and a minimum preferred of two years of professional career experience.
• Proven experience of working with databases, include inputting and extracting data.
• Excellent attention to detail with organizational and planning skills.
• Ability to self-manage, prioritize and work under pressure to tight deadlines.
• Ability to communicate effectively with colleagues, participants and external stakeholders.
• Ability to work effectively as part of a team.
• Undertake any training and professional development as and when required.
• Proficient in Microsoft Office, particularly Access, Word and Excel. Systems experience may include: Microsoft Access, TRACEGAINS, Sharepoint and Red Zone.
$50k-75k yearly est. Auto-Apply 60d+ ago
Director of Quality
Joseph P. Addabbo Family Health Center 4.7
Quality assurance manager job in Malverne, NY
The Director of Quality is responsible for developing, implementing, and maintaining a comprehensive quality improvement (QI) and performance management program for the Federally Qualified Health Center (FQHC). This role ensures compliance with HRSA requirements, NCQA Patient-Centered Medical Home (PCMH) standards, UDS reporting, and other regulatory or accreditation bodies, while fostering a culture of continuous improvement in clinical, operational, and patient experience outcomes.
RESPONSIBILITIES:
* Directly supervises the Quality Coordinators.
* Develops Quality Assurance policies to ensure successful implementation of improvement standards.
* Serves as the primary liaison between JPA and Managed Care Organizations (MCOs), representing the organization in all quality-related engagements and ensuring active participation in MCO quality meetings. Assesses patient medical records to ensure compliance with established quality standards.
* Coordinates and ensures timely completion of the quarterly provider peer review cycle.
* Conduct on-site visits to monitor and assess the implementation of QA/QI activities, including pre-visit planning and daily huddles.
* Aggregates statistical quality assurance data, develops comprehensive narrative reports, and partners with clinical informatics specialists to support data-driven improvements.
* Collaborates with the CMO to revise the Quality Assurance and Utilization Review plan in accordance with HRSA guidelines.
* Coordinates recurring QI/QA meetings with the Quality Coordinators and Department Leads, manages meeting coordination, records minutes, tracks participation, and ensures timely follow-up on all assigned tasks and activities.
* Monitor and track performance on HEDIS and other quality measures across payer contracts.
* Identify and prioritize care gaps in collaboration with clinical and operational teams.
* Develop and implement strategies to close care gaps, including outreach campaigns, provider engagement, and patient education.
* Collaborate with clinical teams, payors, and population health staff to align quality improvement efforts with value-based care goals. Maintain up-to-date knowledge of CMS, NCQA, and payer-specific quality measure requirements.
* Assist in the reporting and analysis of quality metrics to identify trends, disparities, and opportunities for improvement.
* Coordinate with IT and analytics teams to ensure accurate and timely data capture and reporting.
* Support the preparation of documentation and evidence for HEDIS audits and external reviews.
* Contribute to quality improvement initiatives, such as PDSA cycles, root cause analyses, and performance dashboards.
* May be required to perform other duties as assigned or when necessary.
QUALIFICATIONS:
Education:
* Bachelor's degree in healthcare administration, public health, Nursing, or related field required.
* Master's degree in public health, Healthcare Administration, or related field preferred.
* A licensed Registered Nurse (RN) or Nurse Practitioner (NP) with a strong background in healthcare quality improvement will also be considered in lieu of a master's degree.
Experience:
* Minimum 5 years of progressively responsible experience in healthcare quality or performance improvement, preferably in a community health center or FQHC setting.
* Strong working knowledge of HRSA, UDS, NCQA PCMH, and related regulatory requirements.
Skills:
* Demonstrated ability to lead quality initiatives and manage cross-functional teams.
* Proficiency in data analysis and quality improvement tools (e.g., Excel, EHR reporting, QI methodologies). Excellent verbal and written communication skills.
* Experience with risk management, clinical compliance, and patient safety programs is a plus.
Working Conditions:
* Primarily office-based with some travel between clinical sites.
* May require occasional evenings or weekends for meetings or training.
Why Join Us: Be part of a mission-driven organization focused on improving patient outcomes and advancing health equity. Collaborate with cross-functional teams to shape the future of value-based care. Opportunities for growth and professional development in a dynamic healthcare environment.
$110k-139k yearly est. 12d ago
Director, Clinical Quality Assurance
Eisai Us 4.8
Quality assurance manager job in Nutley, NJ
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
$109k-151k yearly est. Auto-Apply 60d+ ago
Director of Quality Improvement
Opengate, Inc. 3.5
Quality assurance manager job in Armonk, NY
Job Description
The Director of Quality Improvement is responsible for ensuring that Opengate's programs conform to all federal and state regulations and that all agency policies and procedures are adhered to. The Director of Quality Improvement develops and implements Opengate's QI plan, inclusive of scheduled internal audits of each department.
Essential Job Functions:
Ensures the agency maintains a comprehensive Quality Improvement Plan that is reviewed and updated quarterly, or as needed, to meet regulatory standards and support the agency's mission and goals for providing quality services.
Develops and implements quality improvement systems across the agency.
Complete internal audits to establish trends or patterns for monitoring and ensuring timely documented completion and implementation of plans of corrective action for internal reviews.
Completes routine scheduled observations of program functions, systems and provides follow up. This includes on-site visits of all program areas for evaluation of program and service delivery.
Meets with department directors, coordinators and managers to share information and make recommendations.
Provides feedback and training recommendations to management and direct support staff.
Attend all external surveys/audits, act as agency liaison with external auditors, and ensure timely responses to POCAs.
Review statements of deficiency and Exit Conference Forms and completes Plans of Correction Action with input from applicable departments/staff.
Collaborate with program administrators to ensure compliance with applicable Federal, State and local regulations and agency policies.
Assist the Chief Compliance Officer in developing trends reports.
Acts as CAS liaison and oversees the coordination of CAS Assessments for anyone receiving services or supports through Opengate.
Assist with the identification of agency training needs resulting from OPWDD, DOH, OFPC, and OMIG regulatory requirements, changes in regulations, deficiencies or internal quality reviews.
Participates on the agency Corporate Compliance Committee as requested.
Must be able to interact/coordinate with OPWDD, OFPC, OMIG, DOH, and other community partners as necessary.
Ensure agency liability notices and updates are distributed and collected upon intake and as needed thereafter.
Identifies, responds to and addresses resident, participant or advocate dissatisfaction with services.
Follows federal, state and local governmental regulatory guidelines pertaining to a safe, healthy and clean work environment, reporting health and safety concerns to the supervisor.
Other duties as assigned by the CCO.
Qualifications:
A bachelor's degree in health, human services, education or management. Master's degree preferred.
Five (5) years of experience working with ID/DD population in an OPWDD setting.
Extensive knowledge of state and federal regulations as they pertain to OPWDD service providers.
Must have excellent interpersonal skills and the ability to interact well with people receiving supports, employees, and external regulatory agencies and stakeholders.
Must have excellent writing, computer, time management, and organization skills.
Physical Requirements:
Ability to work in a professional office environment for extended periods of time, routinely using standard office equipment.
Ability to lift, push and pull up to 50 pounds, as well as bend, kneel and crouch as needed.
Salary: $75,000 - $85,000
Compensation will be commensurate with job qualifications and work experience.
Opengate is committed to equal employment opportunity. We will not discriminate against employees or applicants for em
ployment on any legally-recognized basis including, but not limited to: veteran status, uniform service member status, race, color, religion, sex, national origin, age, physical or mental disability, creed, national origin, ancestry, age, marital status, domestic or civil union partnership status, affectional or sexual orientation, gender identity, genetic information, transgender status, predisposing genetic characteristics, familial status, education, domestic violence victim status, or any other characteristic protected under federal, state, or local law. The Company promotes inclusion and acceptance of all protected classes.
In order to promote and maintain a community culture, employees hired to work at Opengate must legally reside and perform their work in the state of New York, New Jersey, Connecticut, or Pennsylvania.
$75k-85k yearly 31d ago
Precision Manufacturing Process and Quality Manager
Spectrum Comm Inc. 4.2
Quality assurance manager job in Farmingdale, NY
Job Description
Superior Motion Controls designs, produces and delivers precision components and assemblies for defense and aerospace systems. We are seeking a highly experienced and hands-on Process and Quality Manager to oversee all aspects of our Quality Program including design and development, precision machining, assembly and test of electromechanical assemblies. This role is responsible for supervising and scheduling internal inspection personnel and interfacing with engineering and production management to ensure all work products (WIP and final components) meet requirements. The Process and Quality Manager will serve as the principal adviser to executive management on elements of the company's Quality Management System and directly lead the company's efforts to maintain all required certifications with respect to external standards (ISO9001:2015, AS9100, etc.).
Key Responsibilities
▪ Oversee all aspects of the company's Quality Program and the Inspection Department.
▪ Supervise and schedule the activities of all company quality inspectors
▪ Recruit and train Quality Inspectors to ensure adequate staffing to meet demand
▪ Achieve and maintain proficiency as a Quality Inspector
▪ Ensure all inspection tools and systems are calibrated on schedule as required and maintain appropriate documentation.
▪ Lead the Company through all required external quality audits (Standards based such as ISO 9001, AS9100 as well as any customer required)
Requirements
Qualifications
▪ Minimum 10 years experience in quality control, with at least 5 years in a leadership or management capacity; preferably in a precision machining/manufacturing environment
▪ Ability to read and interpret complex engineering drawings and GD&T
▪ Strong skills in coaching and developing inspectors with a range of experience levels
▪ Familiarity with lean manufacturing principles, ERP systems, and performance metrics
▪ Effective communicator with strong collaboration skills across departments
$125k-192k yearly est. 29d ago
Quality Control Manager
Lynkx Staffing LLC
Quality assurance manager job in Saddle Brook, NJ
Quality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to:
Leading, hiring, developing, training, and evaluating QC personnel
Devising sound hiring strategies based on business needs
Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials
Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance
Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies
Assuring alignment and efficient continuity in laboratory practices between sites
Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records
Ensuring completion of all client QC requirements related to GMP cellular products and/or materials
Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable
Prioritizing, scheduling, and managing multiple projects and resources simultaneously
Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings
Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function
Delegating maintenance, tracking, and trending aspects of the deviation reporting system
Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing
Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable
Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation
Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities
Participating in and tracking group budget setting and cost containment drives
Communicating and maintaining trust relationships with senior management, business partners, and clients
Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times
Completing projects and special tasks as assigned by the Global Quality Head
Off-schedule shifts during weekends and holidays based on business requirements a possibility
On-call presence preferred while physical personal presence is not possible
Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.
REQUIREMENTS
BA/BS/MS in a science or relevant field required
Master's in Business Administration or relevant field will be preferred
7 - 10 years' experience in the pharmaceutical, biologics or related industry
Prior cGMP experience required
Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must
Experience in Flow Cytometry is a must
5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff
Sound understanding of current Good Manufacturing Practices (cGMPs)
Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation
Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred
Proven experience in a supervisory or managerial position
Demonstrable experience in developing strategic plans based on business needs
Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries
Thorough knowledge of market changes and forces that influence the company
Proficient with computer software: Microsoft Office, Visio
Strong written, oral, and presentational skills
Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers
Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review
Excellent organizational and leadership skills
Excellent communication, interpersonal, and presentation skills
Outstanding analytical and problem-solving abilities
Strong business acumen
Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner
Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clients Must be able to handle the standard/moderate noise of the manufacturing facility Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
How much does a quality assurance manager earn in White Plains, NY?
The average quality assurance manager in White Plains, NY earns between $68,000 and $143,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.
Average quality assurance manager salary in White Plains, NY
$98,000
What are the biggest employers of Quality Assurance Managers in White Plains, NY?
The biggest employers of Quality Assurance Managers in White Plains, NY are: