Director of Nursing Quality | NYC
Quality assurance manager job in New York, NY
A mission-driven safety-net health system serving one of NYC's most vibrant communities is seeking a Director of Nursing Quality - a leader who knows how to turn Quality and CQI principles into meaningful improvements that nurses actually feel at the bedside.
What You'll Do:
Lead system-wide Quality and CQI initiatives, support nurse managers, guide Joint Commission and DOH readiness, and strengthen the culture of patient safety. You'll translate data into real-world practice and foster collaboration across departments.
What You Bring:
✔ NYS RN, BSN + Master's
✔ 3+ years of leadership experience
✔ Strong grounding in Quality, policy development, and data-driven change
✔ Ability to resolve escalated issues with calm, clarity, and cross-team collaboration
✔ CPHQ/CPHRM preferred
This is a high-impact leadership role in a community that values equitable, high-quality care - and the nursing leaders who make it possible.
To explore this confidentially, schedule here:
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Thanks!
James Weston, Managing Partner
Polaris Placement, LLC
************
Making connections that make all the difference.
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Quality Management Specialist II
Quality assurance manager job in Princeton, NJ
Duration: 12 months
The Quality Management Specialist II tasks include:
CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings.
With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies.
Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits.
Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan.
Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses.
Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings.
Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1)
Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates.
Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings.
Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes.
Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned.
Qualifications:
Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Vicky
Email: **********************************
Internal Id: 25-54443
Quality Assurance Manager
Quality assurance manager job in Dayton, NJ
JOB PURPOSE :
Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated.
KEY ACCOUNTABILITIES:
Regular and predictable onsite attendance and punctuality.
Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner.
Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials.
Coordinates communication of production status to next shift; attends daily update meetings as required.
Manages personnel for in-process filling and inspection/packaging monitoring.
Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required
Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents.
Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements.
Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials.
Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
Places lots on HOLD if Quality issues are detected and notifies senior management.
Assists the QA management in developing on department budget.
Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
Manages attendance records for all direct reports.
QUALIFICATIONS:
College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience
Ph.D. in relevant field with 0-3 years' experience
Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial
EXPERIENCE:
Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must
SKILLS:
Must have history of strong documentation skills and attention to detail
Familiarity with cGMPs and CFR for US and EU
Excellent organizational skills and ability to multi-task and perform work in a timely manner
Demonstrates ability to lead a department, projects and meetings effectively
Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
General computer skills and ability to prepare presentations and address large groups
Demonstrated attention to details and accuracy
The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
Mentoring abilities as well as effective communication, (written and oral) are required.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Director, Capital Budget and Contract Control (Design and Construction)
Quality assurance manager job in New York, NY
Work Shifts
9:00 A.M - 5:00 P.M
Duties & Responsibilities
Under the direction of the Budget Director (Corporate), compiles, administers and obtains approvals of the Capital Facilities Budget; evaluates project proposals, monitors and reports regularly on project status; maintains Corporation records of funds, contracts and cash outlays. Develops, recommends and implements criteria and procedures to improve the effectiveness of the Corporation's facilities improvement programs.
Examples of Typical Tasks
Directs annual budget cycles which include receipt and program and fiscal analysis of capital requests and Article 28 applications from health care facilities. Evaluates requests and makes recommendations to Director of Planning for funding and work orders.
Obtains approvals of Capital Budget, Programs and Contracts from the City, Board of Estimate, Financial Control Board, HSA and State Health Department.
Generates project cost data and establishes criteria procedures necessary to maintain a sound investment strategy and to sustain effective participation by the hospitals, community boards and regulatory and financing agencies in our facilities improvement programs.
Monitors and reports regularly on Capital project status to the Corporation and the City of New York using a computerized Management Information System.
Maintains records of capital funds, expenditures and cash outlays. Certifies capital funding for expenditures and estimates costs for fixed asset accounting and reimbursement reporting.
Interfaces with City Comptroller and land and construction agency records to establish costs of construction, debt management and related services furnished by the City for Corporation purposes and maintains separate records of these cost auditable to City source records.
Assists in audits of financial records as required by the Corporation, the City Comptroller, City Construction Board, State Emergency Financial Control Board and reimbursement agencies.
Prepares forecasts of fund and cash requirements and requisitions cash from the City Capital Project Fund.
Administers an employee time recording and billing system to record time and cost of staff design and construction services for each capital project and vouchers and receives cash from the city Capital Project Fund for staff services provided under interfund agreements.
Administers contract change control requirements.
Evaluates purchase and contract regulations, procedures and standard contracts and certifies purchase and receipt of all major equipment and permanently identifies the piece and record data in the major equipment inventory control system.
Develops procedures with criteria for Prequalification of Contractors as provided in Section 8 of the Corporation Act. Solicits, evaluates and communicates prequalification status to all contractors maintaining lists and individual contractor financial and experience records.
Serves as a member of the Architectural and Engineering Selection Board.
Supervises and directs the staff assigned to assist in the performance of these major duties and evaluates employee performance.
Minimum Qualifications
1. A Masters Degree in Business Administration, Science, Health Care Administration, Engineering or related discipline from an accredited college or university or a license as a Professional Engineer or registration as an Architect; and,
2. Eight years managerial experience in Capital Program or budget work in the construction field including four years experience in budget administration and management of health care facilities; or,
3. A satisfactory equivalent combination of education, training and experience.
Department Preferences
Preference will be given to qualified candidates with the following knowledge, abilities, education, experience and/or skills:
EDUCATION:
A Master's degree from an accredited college or university in Hospital Administration, Health Care Planning, Business Administration, Public Administration or an approved related program.
LICENSE:
A New York State license as a professional engineer or registered architect or a license as a professional engineer or registered architect from a state that has reciprocity with New York State may be substituted for the four years of education and experience.
EXPERIENCE:
At least 10 years of related experience in design and/or construction management with experience in healthcare clinics; or as a journeyperson in one or more of the skilled building construction trades.
Full-time satisfactory experience in planning, design and program development pertaining to meeting health needs, health care planning, design and program implementation, with at least three years of responsible level administrative experience coordinating the planning, design, and construction and commissioning.
KNOWLEDGE IN:
Thorough knowledge of the principles, practices and methods of Healthcare and Space Management.
Long Term Capital Planning
Design Management, Construction Management, Budget Management and Time Management
Negotiations
Regulatory (DOB, FDNY, DOH) Close outs
SKILLS:
Excellent verbal / written skills.
Excellent technical, conceptual, and financial skills.
Motivate team efforts to accomplish goals.
COMPUTER PROGRAMS/SOFTWARE OPERATED:
Microsoft Word and Excel (required)
Microsoft Access,
MS Project
Auto CADD/Revit.
Procore/E-builder or similar
Quality Assurance Specialist
Quality assurance manager job in Middlesex, NJ
The QA Specialist will play a key role in ensuring the quality, safety, and compliance of raw materials and related processes in support of biotechnology manufacturing operations. This position is responsible for reviewing raw material documentation, coordinating and reviewing raw material sampling and release, verifying QC data, and supporting the review of stability reports to ensure adherence to internal procedures, regulatory guidelines, and cGMP standards.
Key Responsibilities:
Review and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance.
Perform raw material release activities in accordance with established SOPs and GMP requirements.
Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody.
Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications.
Review and track stability reports, ensuring timely completion, accuracy, and adherence to protocols.
Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data.
Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation.
Participate in internal and external audits, as needed.
Identify and support opportunities for continuous improvement in quality systems and documentation processes.
Qualifications:
Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required.
2-5 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry.
Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles.
Experience reviewing QC data, raw material documentation, and stability reports.
Detail-oriented with strong organizational and documentation skills.
Excellent communication and teamwork abilities.
Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred.
GIS QA/QC Support Specialist
Quality assurance manager job in New York, NY
About the Company
The eGIS team is seeking two skilled contractors to support data quality assurance and testing efforts for the Gas division of our project. This role involves working with Schneider's ArcFM and ESRI GIS platforms to validate and enhance the integrity of migrated mapping data.
About the Role
This role involves working with Schneider's ArcFM and ESRI GIS platforms to validate and enhance the integrity of migrated mapping data.
Responsibilities
Perform spatial and attribute data validation for legacy Gas mapping data migrated to ESRI systems.
Conduct spatial queries and analysis to ensure connectivity and accuracy of Gas infrastructure components.
Review and correct land base symmetry and structure connectivity.
Update and standardize map symbology as needed.
Execute system testing to verify functionality of new mapping tools.
Maintain organized tracking of data review progress using Excel and other tools.
Prioritize tasks and manage timelines to meet project milestones.
Support additional eGIS initiatives as required.
Qualifications
Bachelor's degree in a relevant field.
Minimum of 2 years of hands-on experience with ESRI ArcMap.
Proficiency in MXD creation, spatial queries, and spatial analysis.
Strong understanding of GIS concepts and ESRI platform tools.
Self-motivated, detail-oriented, and capable of working independently.
Excellent analytical and organizational skills.
Proficiency in Microsoft Office applications.
Required Skills
Experience with Schneider's ArcFM platform.
Experience with ESRI GIS platforms.
Familiarity with utility mapping systems and Gas infrastructure.
Ability to interpret various types of Gas maps and technical documents.
Experience supporting GIS-related software implementation projects, including configuration, testing, and deployment of geospatial tools or platforms.
Familiarity with IT project management principles, particularly in environments involving data quality assurance and system integration.
Exposure to project tracking tools (e.g., Jira, Trello, MS Project) and collaborative platforms used in technical project environments.
Ability to work effectively with cross-functional teams including GIS analysts, developers, and project managers.
Understanding of change management and user support strategies during technology rollouts or upgrades.
Preferred Skills
Familiarity with utility mapping systems and Gas infrastructure.
Ability to interpret various types of Gas maps and technical documents.
Repair Quality Engineer
Quality assurance manager job in Englewood, NJ
Hanwha Vision America (HVA) is an affiliate of the Hanwha Group, a Fortune Global 500 company. HVA is an industry-leading provider of advanced network video surveillance products, including IP cameras, storage devices, and video management systems, founded on world-class technologies. We offer end-to-end security solutions and have achieved global success across a wide range of industry verticals, including retail, transportation, education, banking, healthcare, hospitality, and airports.
Hanwha Vision America (HVA) is seeking a Repair/ Quality Engineer to support HTCC's engineering and repair operations by performing intake screening, basic diagnostics, quality checks, and documentation.
The role ensures that incoming units are properly evaluated, repair processes run efficiently, and completed products meet quality standards before shipment. This position combines repair-support responsibilities with quality assurance activities to improve workflow efficiency, accuracy, and overall service performance.
Major Functions / Accountabilities
Perform initial screening and basic functional checks on incoming units
Identify obvious issues or simple conditions that can be resolved before repair
Support repair workflow by preparing units, organizing information, and performing basic diagnostics
Conduct quality checks on completed repair units to ensure they meet internal standards
Document inspection results and update system records accurately
Assist with failure analysis for repeated issues and provide feedback to engineering
Inspect packaging quality and verify final shipment readiness
Collaborate with repair staff, engineering, logistics, and warehouse teams as needed
Maintain checklists, guidelines, and standard procedures for inspection work
Support process improvements related to efficiency, quality, and documentation compliance
Knowledge, Skills & Requirements
Preferred background: Electronics, Electrical Engineering, Computer Engineering, or related field
Basic understanding of electronic components (e.g., resistors, capacitors, diodes)
Ability to use multimeters and basic diagnostic tools
Strong attention to detail and problem-solving skills
Ability to follow technical checklists and standardized procedures
Proficiency with Microsoft Office and basic system data entry
Bilingual (Korean/English) preferred but not required
Sr. Quality Systems Engineering
Quality assurance manager job in Asbury Park, NJ
Sr. Quality Systems Engineering opp. w/ manufacturer of aero evacuation systems for aircraft e.g. safety slides, life rafts, vests. Maintain/Improve AS9100 Sys. PoC w/ 3rd Party Registrar & regulators i.e. FAA. Includes: Presentations to customers, regulators about the QMS; SIPOC documentation & PEAR diagrams; meeting KPIs; developing maintaining compliance matrices for regulator, cert & customer reqs; determining training needs; develop/ coordinate internal audits for all facilities; manage CAR process; present internal audit results at 1/4 Mgmt. review meetings; support QMS activities all facilities. Maintain quality sys. docs. e.g. QSP, SQD, GIP, SIP & others. Maintain Service Centers/Satellite Repair Stations/Quality Control Manuals & EU Aviation Safety Agency Supps. Member of Warranty Review Board, contribute to continuous improvement processes, e.g. warranty team, lean initiatives, developing PFMEA all facilities. Biz travel to facilities in MX, & MS, 2 wks./quarter or less, for meetings
Considering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out.
& Quality Audits. Min. Qual. BSIE
or foreign equiv. degree plus 2-yrs.
relevant exp. $110,311.00/yr. Email Safran Aerosystems Evac. Wall Township NJ. We prohibit discrimination in staffing practices, because of race, color, religion, sex, age, veteran status, marital status, disability, sexual orientation, or national origin. xevrcyc
JobiqoTJN. , Location: TINTON FALLS, NJ - 07727
QA Director
Quality assurance manager job in New York, NY
Mandatory Technical / Functional Skills • Software Quality Assurance consultant with at least 10 years' experience in playing QA Director Technical/Functional Skills • Experience in formulating QA strategy and leading QA execution for large programs • Ability to play advisory role to customer on how to manage testing in an end to end scenario (right from planning and requirement phase to User acceptance testing)
• Excellent understanding of QA metrics, entry/exit criteria
• Experience in Insurance or Financial services industry sector will be good to have
Roles & Responsibilities
• Formulate Software Quality Assurance strategy (QA and UAT)
• Establish quality standards
• Establish quality documentation by writing and updating quality assurance procedures
• Participate in Requirement analysis, Test strategy sessions of the program to understand and gather the necessary details to ensure its alignment to quality strategy, standards and procedures
• Review all the program testing deliverables across Software Testing Life Cycle (STLC)
• Ensure testing deliverables completeness on test scope coverage
• Ensure program testing schedule is realistic
•Ensure traceability on program requirement to test cases & result
• Perform root cause analysis and create pattern to identify frequently occurring defects
• Arrange review finding walk-through sessions, publish detail review findings
• Provide corrective actions/recommendations/best practices in reducing defect trend
• Track closure of review findings and implementation of actions/recommendations
• Ensure program testing risks and assumptions are clearly articulated
• Create and publish program quality dashboard
Thanks & Regards,
Additional Information
If you are comfortable with the position and location then please revert me back at the earliest with your updated resume and following details or I would really appreciate if you can call me back on my number.
Full Name:
Email:
Skype id:
Contact Nos.:
Current Location:
Open to relocate:
Start Availability:
Work Permit:
Flexible time for INTERVIEW:
Current Company:
Current Rate:
Expected Rate:
Total IT Experience [Years]:
Total US Experience [Years]:
Key Skill Set:
Best time to call:
2 Slots for phone interview:
In case you are not interested, I will be very grateful if you can pass this position to your colleagues or friends who might be interested.
All your information will be kept confidential according to EEO guidelines.
Food Safety Quality Assurance Manager
Quality assurance manager job in Carlstadt, NJ
& Sons 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.
Director, Clinical Quality Assurance
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:
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E-Verify Participation
Auto-ApplyDirector: Ambulatory Care Quality Assurance
Quality assurance manager job in New York, NY
Under the direction of the Vice President, the Director of Ambulatory Care Quality plans, implements, and directs quality improvement and patient experience initiatives across all SBH Ambulatory Care sites. The Director is responsible for developing and managing action plans to improve performance on quality metrics, maintain regulatory compliance, and enhance the patient experience.
The position leads the governance and facilitation of the Ambulatory Quality Committee and the Ambulatory Patient Experience Workgroup. The role oversees performance improvement projects, chart audits, documentation reviews, and new workflow implementations to enhance outcomes and patient-centered care. The director also assists the VP with departmental compliance programs and reviews.
Responsibilities:
Provides leadership to the Ambulatory Care Quality & Population Health department, supporting the VP with department strategy, operations and management.
Prepares and facilitates the Ambulatory Quality Committee, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans.
Prepares and facilitates the Ambulatory Patient Experience Workgroup, including agenda development, data reporting, and tracking of follow-up items and performance improvement plans.
Designs and implements quality assurance and performance improvement (QAPI) initiatives to improve patient care, advance population health, and drive value-based care outcomes.
Supports Ambulatory Care Directors and leaders to implement QAPI initiatives in their own areas, and to develop QAPI reports and Performance Improvement posters.
Develops training content and performance feedback tools to coach ambulatory providers and staff on quality improvement best practices.
Leads internal audit processes, regulatory survey readiness (e.g., Joint Commission, NCQA, NYS DOH), and documentation compliance reviews.
Assists the VP with departmental compliance programs and reviews including chart and billing audits, and investigations.
Performs other related duties at the discretion of the Vice President.
Attends scheduled department and division meetings and participates as appropriate.
Director, Head of FCC Quality Assurance
Quality assurance manager job in New York, NY
Job Description
Community Federal Savings Bank (CFSB), located in New York City is seeking a highly skilled and detail-oriented Head of Financial Crimes Compliance Quality Assurance to join our Program Management & Assurance function within the Compliance department. CFSB offers a full range of banking services including ACH settlement services, pre-paid card issuance, and retail banking. In addition to serving our general customer base, we also service various types of money service businesses and FinTech companies. This individual will be primarily responsible for overseeing a robust quality assurance program to ensure compliance controls are operating as designed. They will drive strategic Financial Crimes Compliance QA initiatives, enhance transparency, and provide data-driven insights to inform decision-making and regulatory readiness.
Key Responsibilities:
Enhance and maintain the Financial Crimes Compliance Quality Assurance (QA) framework to assess whether key compliance control activities-conducted internally or by external consultants-adhere to internal standards, regulatory expectations, and Bank policy.
Implement and continuously refine standardized QA test scripts, workpapers, and documentation templates to drive consistency, transparency, and auditability across QA reviews.
Lead and develop a high-performing team of Financial Crimes Compliance QA Managers and staff, providing coaching, mentorship, and oversight to ensure effective execution and professional growth.
Partner with Internal Control functions to align Financial Crimes Compliance QA insights with broader risk trends, inform planning cycles, and enhance control evaluations across business units.
Stay current on regulatory developments, enforcement actions, and industry best practices; translate regulatory changes into QA control enhancements and update procedures accordingly.
Provide structured, actionable feedback and guidance to control owners and business partners based on QA findings, supporting the adoption of practical, risk-aligned solutions and best practices.
Lead the design and delivery of training content and workshops to improve the quality, consistency, and defensibility of investigations, control execution, and documentation.
Establish Financial Crimes Compliance QA metrics and dashboards to support continuous improvement, trend analysis, and executive-level reporting to governance committees, senior leadership, and regulators.
Ensure Financial Crimes Compliance QA processes integrate technology and data analytics where feasible to improve efficiency, risk detection, and traceability.
Act as a strategic partner across Compliance, Legal, Audit, Operations, and Technology to promote a culture of accountability, transparency, and continuous improvement.
Support internal and external regulatory examinations by providing Financial Crimes Compliance QA reporting, documentation, and commentary as needed.
Qualifications:
Deep subject matter expertise in regulatory compliance, quality assurance methodologies, and risk management within the financial services industry.
Proven ability to design and lead Financial Crimes Compliance QA programs in complex, matrixed environments involving third-party partnerships, fintech platforms, and high-risk product offerings.
Demonstrated experience presenting Financial Crimes Compliance QA findings, thematic trends, and risk insights to executive leadership, Board-level committees, and regulatory agencies.
Strong working knowledge of BSA/AML/OFAC requirements.
Strategic mindset with the ability to drive long-term program maturity while executing detailed operational reviews and initiatives.
Proficient in leveraging technology platforms to support Financial Crimes Compliance QA activities, including GRC systems, workflow tools, and automated testing solutions.
Exceptional written and verbal communication skills, with the ability to translate complex compliance matters into actionable, business-aligned recommendations.
Collaborative leader with a track record of building high-performing teams and influencing cross-functional partners across Compliance, Legal, Risk, Operations, and Technology.
Bachelor's degree required; advanced degree (e.g., JD, MBA) or relevant professional certifications (e.g., CAMS, CRCM, CISA, CFE) strongly preferred.
Minimum of 10 years of experience in Compliance, Audit, Risk, or Internal Controls, with at least 5 years in a senior leadership or QA oversight role.
Prior experience overseeing Financial Crimes Compliance QA or testing programs focused on consumer protection, AML, sanctions, or third-party oversight is highly desirable.
Exposure to dynamic and hybrid business models, such as banking-as-a-service (BaaS), money service businesses (MSBs), fintech partnerships, or international payments, is strongly preferred.
Salary: $180,000 - $210,000 K / year
"Base salary range does not include performance-based bonus and/or other benefits, where applicable. Actual base salary offer will vary based on skills and experience."
About Community Federal Savings Bank (CFSB)
Community Federal Savings Bank (CFSB) is a federally chartered bank founded in 2001 and headquartered in New York City. CFSB has focused on providing superior service and added value to clients though a solid understanding of relationship banking. We offer a full range of services, including loans, bill payments, card services, internet banking, and merchant processing.
We are an equal opportunity employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, military and/or veteran status, or any other Federal or State legally-protected classes.
Director, Quality Assurance
Quality assurance manager job in New York, NY
Job Description
Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering's R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering's team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development.
General Summary of Duties:
The Director, Quality Assurance is a strategic leadership role responsible for overseeing key aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering's ongoing development programs with local, state, federal, and international requirements. This position will be supportive in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products.
A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player.
Specific Duties, may include but not be limited to the following:
· Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance
· Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues.
· Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance.
· Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding
· Work on qualification and validation plans, assure proper batch releases and disposition.
· Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA)
· Provide quality input on contracts and serve as a point person for negotiations of quality agreements.
· Champion a culture of quality and continuous improvement across manufacturing and development operations.
Desired Skills and Qualifications
· Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry
· Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements
· Demonstrated hands on experience working on complex projects.
· In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.
· Strong partnering and communication skills required, as well as project management skills.
· Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.
· Ability to work effectively in a collaborative, fast-paced environment.
Pay scale: $175-210 annually, final offer to be commensurate with education and depth of experience, with potential for equity participation, bonus and comprehensive benefits.
Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available.
Physical Demands/ Working Conditions
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role.
While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role.
Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.
Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam.
Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.
Quality Control Laboratory Manager
Quality assurance manager job in Cranbury, NJ
Create a future where DNA is no longer destiny. Join Rocket Pharma.
Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.
Position Summary
This Quality Control (QC) Laboratory Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset.
The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy.
Responsibilities
Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents
Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays
Supporting Management by performing peer reviews of testing data
Supporting Method Performance tracking and trending through data entry, verification, and record archival
Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts
Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc.
Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration
Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management
Support revision of SOPs and forms to improve workflows in QC
Overseeing Housekeeping activities of lab areas
Verifying Logbooks are reviewed on time
Tracking Lab Notebooks lifecycle
Working with EHS to improve Safety Culture in QC
Qualifications
M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry.
Ability to be onsite 5 days per week
Deep understanding and experience with working in a GMP environment
Experience with dd PCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays
Ability to work independently and make decisions
Leadership experience and project management skills to support a multi-project environment in small biotech.
Physical Requirements:
Constantly works in a GMP lab environment with analytical instruments, reagents and cleaning materials
Cleaning with biohazard materials and chemical solutions including bleach and Spor-Klenz
Constantly wears proper PPE including lab coat, safety glasses and chemical resistant gloves
Must be able to remain in a stationary position for 50% of the time
Must be able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens
Constantly communicates verbally with people to exchange information, and give and receive instructions
Frequently positions self to set-up, operate, clean, and maintain process equipment and handle materials
Compensation
The expected salary range for this position is $122,000 to $144,000.
At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market.
For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.
In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).
EEO Statement
A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
Auto-ApplyQuality Manager - Food Manufacturing
Quality assurance manager job in New York, NY
Job DescriptionJob Title: Quality Manager - Food Manufacturing
About the Role: We are seeking a dedicated and experienced Quality Manager to join our team in the food manufacturing sector. The ideal candidate will be responsible for ensuring that our products meet the highest standards of quality and safety. You will lead quality assurance initiatives and drive continuous improvement across all production processes.
Key Responsibilities:
Develop, implement, and maintain quality assurance protocols and procedures specific to food manufacturing.
Oversee the quality control processes to ensure compliance with industry standards and food safety regulations.
Collaborate with cross-functional teams to identify and resolve quality issues.
Conduct regular audits and inspections to ensure adherence to quality standards and regulatory requirements.
Analyze data and reports to identify areas for improvement and implement corrective actions.
Lead and mentor the quality assurance team to achieve departmental goals.
Liaise with suppliers and vendors to ensure quality standards are met throughout the supply chain.
Qualifications:
Bachelor's degree in Food Science, Quality Management, Engineering, or a related field.
Proven experience as a Quality Manager or similar role in the food manufacturing industry.
Strong knowledge of quality assurance methodologies and food safety standards (e.g., HACCP, ISO 22000).
Excellent analytical and problem-solving skills.
Strong leadership and communication abilities.
Experience with quality management software and tools.
Attention to detail and a commitment to excellence.
Preferred Skills:
Certification in quality management or food safety (e.g., Six Sigma, CQE).
Familiarity with regulatory requirements relevant to the food industry.
QUALITY MANAGER MANUFACTURING
Quality assurance manager job in New York, NY
Job Description
QUALITY MANAGER to 130k
MANUFACTURING ISO 9001 Handson Leader Aerospace industry
must have enough work/life experience
5-7 years management experience
5-7 years machining experience
Career progression in the quality field
ISO
9001 - 14001 - 45001
ITAR
Environment & Safety experience
INDUSTRIAL MANUFACTURING DOD MANUFACTURING ITAR A PLUS
Westchester County NY . Long established, financially
stable manufacturer.
APPLICANT REQUIREMENTS: MUST HAVE...
5-7 years of management experience, ideally in a manufacturing or job shop setting
5-7 years of machining experience with a solid understanding of dimensional tools (e.g. calipers, micrometers, Sunnen gauges, optical comparator, CMM machines)
Demonstrated career progression in the quality field
ISO 9001:2015 and AS9100 experience required; certifications in ISO 14001, ISO 45001, or similar a plus
Experience with ITAR compliance
Exposure to or direct involvement in environmental and safety standards (EHS)
Excellent blueprint reading and interpretation skills
Familiarity with Pre-Production Approval Process (PPAP) and Failure Mode Effects Analysis (FMEA)
Root Cause Analysis and Product Control Plans/Inspection Methods
Strong grasp of statistical process improvement techniques, including Six Sigma (Green or Black Belt preferred)
Excellent math, computer, and communication skills
High energy, highly organized, and detail-oriented
Bachelor's degree preferred; however, equivalent work/life experience will be strongly considered
DUTIES and RESPONSIBILITIES:
Serve as the Quality System Management Representative, maintaining and auditing the company-wide ISO 9001 Quality Management System
Manage the daily operations of the Quality Department in an ISO 9001 / AS9100 environment
Oversee physical inspections of incoming materials, in-process production, and final product before shipment
Maintain and control quality documentation including the Quality Manual, SOPs, and Work Instructions
Lead and participate in internal audits, address nonconformances, and develop corrective action plans
Collaborate with cross-functional teams to monitor and enhance product quality
Prepare reports and support quarterly executive management reviews on quality metrics and audit outcomes
Drive continuous improvement initiatives and enforce company quality standards
Support environmental and workplace safety practices in coordination with EHS requirements
A comprehensive benefits package which includes
Medical, vision, dental, life insurance
Sick days, holidays, vacation
401(k) Plan
Director of Quality Assurance and Training
Quality assurance manager job in New York, NY
The Director of Quality Assurance & Training ensures appropriate and effective monitoring of existing procedures of program operations and delivery of services. The position also maintains an ongoing staff training program to ensure that staff are up to date on policies, procedures, and enhanced service practices.
What You'll Do
Create SOPs and Desk Guides for new and existing programs, reviewing and updating materials for programs and conducting training with staff to ensure understanding and compliance with both funder and Fedcap requirements.
Develop and maintain an annual report that provides a thorough description of Fedcap's Quality Assurance activities with an established Quality Improvement Plan (QIP) model.
Develop and implement quality assurance tools to measure and assess the impact of systems, policies and protocols on operational efficiencies and program effectiveness.
Conduct site visits to observe staff interaction with participants including intakes, service plan creation, and workshops.
Review case files for completeness, accuracy, and compliance.
Monitor Customer Service standards including conducting participant focus groups and analyzing surveys to gather feedback and increase awareness of participants' perspective of program services.
Prepare monthly and quarterly reports for Senior Leadership and regulatory bodies.
Identify gaps in program and staff performance and designing and conducting staff training to cure deficiencies and reiterate company standards.
Develop and conduct training programs to provide to WeCARE operations staff on various policies, procedures, and best practices.
Research and continuously update training modules on various topics relevant to providing the best possible services to WeCARE participants.
Assist with external audits conducted by funders and third-party auditors.
Conduct safety and risk assessment to ensure compliance with ADA and regulatory standards at service locations.
Work collaboratively with program departments, external agencies and stakeholders to support compliance efforts and monitor remediation (Corrective Action) activities.
You're a great fit for this role if you have:
A bachelor's degree in public health, public administration, human services, or a related field, with master's degree preferred.
At least 2 years' experience in quality assurance, preferably in social services, public health, or workforce development.
Experience with workforce development is a plus.
Compensation
$120,000-$130,000
The Fedcap Group
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. We are an EEO employer committed to diversity, M/F/D/V.
Auto-ApplyQuality Manager - Supplier ODA Focal
Quality assurance manager job in Plainfield, NJ
Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description
Key Accountabilities:
•Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives.
•Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication.
•Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives.
•Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions.
•Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements.
•Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety.
•Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence.
•Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates.
•Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions.
•Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals.
•Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives.
•Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings.
•Ability to access and work in SAP or other Warehouse Management System
•Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals.
•Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives.
•Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings.
•Ability to access and work in SAP or other Warehouse Management System
The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies
Qualifications:
Minimum Requirements:
This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies.
When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control.
•Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control.
•ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance.
•3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry.
•Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC.
•Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills.
•Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment.
Preferred Requirements:
•ASQ certification
•ISO Lead Assessor Certification
•5 years plus Quality Assurance/Control
•3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience).
•Training in strategic planning and motivation
Benefits Overview
We offer competitive company benefits to eligible positions, such as :
Medical, Dental, Vision Insurance
Life Insurance and Disability
Voluntary Wellness Programs
401(k) and RRSP programs with Company Match
Paid Vacation and Holidays
Tuition Reimbursement
And more!
Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information.
Disclaimer
This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information.
TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers.
TK does not:
1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.;
2. Request payment of any kind from prospective jobseekers or candidates for employment;
3. Authorize anyone to collect money or agree to any monetary arrangement in return for a job at TK;
4. Send checks to job seekers; or
5. Make job offers through third parties. In the event TK uses professional recruitment services through a third party, offers are always made directly by TK and not by any third parties.
PLEASE NOTE:
1. TK strongly recommends that potential jobseekers do not respond to such fake solicitations, in any manner;
2. TK will not be responsible to anyone acting on an employment offer that is not directly made by TK;
3. Anyone making an employment offer in return for money is not authorized by TK; and
4. TK reserves the right to take legal action, including criminal action, against such individuals/entities.
TK follows a formal recruitment process through its own HR department and applications are evaluated by its HR department through pre-defined processes. Please visit our official careers website at ******************************** to view authentic job openings at TK.
If you receive any unauthorized, suspicious, or fraudulent offers or interview calls, please email us at **********************************************.
We shall not accept any liability towards the representation made in any fraudulent communication or its consequences, and such fraudulent communication shall not be treated as any kind of offer or representation by TK or its group companies and affiliates.
Auto-ApplyQuality Assurance Coordinator
Quality assurance manager job in Lakewood, NJ
Full-time Description
SS White Burs is a leading dental device manufacturer that strives to bring high quality dental products to market, enabling practitioners to work more efficiently and to maximize patient comfort and quality. The creation of unique and differentiated products is the cornerstone of SS White Dental. Our footprint has been around for 170 years and makes us one of the most well recognized and trusted names in the industry today.
Requirements
Manages Customer complaints (RMA: Return Material Authorization):
· Receive and organize return product for RMA process
· RMA processing which involves receipt/system transaction and proper disposition of material in Epicor as per Procedure PROSP9
· Perform needed testing of product according to complaint and as per Work Instruction WISP901.
· Recording of evaluation results for quality complaints
· Physical movement/disposition of product
· Proper closeout of customer complaints in Epicor
· Closeout DMRs generated for quality related complaints
Calibration:
· Manage calibration program which includes monthly calibration schedule, maintaining calibration records, calibration results entry in GageTrak and conduct calibration inspection when needed as per procedure PROSP5.
· Schedule calibration for outsourced calibration equipment which includes obtaining quotes from vendor, completing internal purchase requisition to get Purchase Order from Purchasing Department.
Other responsibilities and functions:
· Generate and issue COC (Certificate of Compliance) and COA (Certificate of Analysis) as requested by Customer and according to Shipping Pick list
· Assist with File Heat Treating as needed
· Manage set-up bin (in Epicor and physical inventory)
Qualifications:
· High school diploma or equivalent
· Proficiency using Microsoft Office and other Windows based applications
· Demonstrated ability to read, write legibly, and understand English
· Highly organized & detail orientated
· Ability to communicate and work with all departments and all levels of management