Current jobs related to Senior Quality Assurance Manager - Queensbury - Delcath
-
Lead Quality Assurance Engineer
3 weeks ago
Queensbury, New York, United States Praxis Technology Full timeAre you passionate about ensuring product excellence?About UsPraxis Technology is a pioneering manufacturing firm specializing in the design and production of titanium components for medical devices, aerospace applications, and various consumer markets. We are dedicated to creating sustainable solutions that enhance the quality of life for individuals. Our...
-
Queensbury, New York, United States Cmj Llp Full timeAbout the RoleCmj Llp is seeking a highly skilled and experienced Senior Associate, Assurance and Advisory Services to join our team. As a key member of our audit and accounting department, you will be responsible for providing oversight to all phases of audit, compilation, or review engagements.Key ResponsibilitiesEngagement Oversight: Provide oversight to...
-
Senior Associate, Assurance
1 month ago
Queensbury, United States Cmj Llp Full timeCMJ is not your typical accounting firm. We are a cohesive team offering a full scope of services and solutions to drive the success of our clients businesses. We work as advisors to management teams, providing sound, informed feedback that contributes to growth and long-term stability.CMJ was founded in 1988, by Paul Curtis and Bill Jeffreys with a...
-
Senior Associate, Assurance
3 weeks ago
Queensbury, United States CMJ, LLP Full timeCMJ is not your typical accounting firm. We are a cohesive team offering a full scope of services and solutions to drive the success of our clients’ businesses. We work as advisors to management teams, providing sound, informed feedback that contributes to growth and long-term stability.CMJ was founded in 1988, by Paul Curtis and Bill Jeffreys with a...
-
Senior Associate, Assurance
3 weeks ago
Queensbury, United States CMJ, LLP Full timeCMJ is not your typical accounting firm. We are a cohesive team offering a full scope of services and solutions to drive the success of our clients’ businesses. We work as advisors to management teams, providing sound, informed feedback that contributes to growth and long-term stability.CMJ was founded in 1988, by Paul Curtis and Bill Jeffreys with a...
-
Quality Assurance Specialist
1 day ago
Queensbury, New York, United States Praxis Technology Full timeAbout Praxis TechnologyWe are a manufacturing company that designs and develops titanium parts for medical devices, aerospace, and other consumer markets. Our mission is to create sustainable flexibility that delivers maximum impact to make people's lives better.Job SummaryWe are seeking a Quality Technician to join our team. The successful candidate will be...
-
Quality Assurance Specialist
5 days ago
Queensbury, New York, United States Praxis Technology Full timeAbout Praxis TechnologyWe are a manufacturing company that designs and develops titanium parts for medical devices, aerospace, and other consumer markets. Our mission is to create sustainable flexibility that delivers maximum impact to make people's lives better.Job SummaryWe are seeking a Quality Technician to join our team. The successful candidate will be...
-
Director of Social Services
1 week ago
Queensbury, New York, United States Quality Talent Group Full timeAbout the Role:Quality Talent Group is seeking a highly skilled and experienced Director of Social Work to join our team. As a Director of Social Work, you will be responsible for leading the Social Services Department and ensuring that our residents receive the highest level of care and support.Key Responsibilities:Leadership and Management: Direct,...
-
Social Work Director
8 hours ago
Queensbury, New York, United States Quality Talent Group Full timeDirector of Social WorkAt Quality Talent Group, we are seeking a highly skilled and experienced Director of Social Work to join our team. As a key member of our leadership team, you will be responsible for developing and implementing policies and goals for our Social Services Department.Key Responsibilities:Develop and implement policies and goals for the...
-
Housekeeping Quality Supervisor
4 weeks ago
Queensbury, New York, United States Home2 Suites, Queensbury Full timeOverview of the Housekeeping Quality Supervisor RoleWe are a hospitality organization seeking a committed individual to become part of our team as a Housekeeping Quality Supervisor. In this essential role, you will be tasked with ensuring the cleanliness and quality standards across our accommodations.Key Responsibilities:Oversee and mentor housekeeping...
-
Housekeeping Quality Supervisor
3 weeks ago
Queensbury, New York, United States Home2 Suites, Queensbury Full timeOverview of the Housekeeping Quality Supervisor RoleWe are a prominent hospitality organization seeking a committed individual for the position of Housekeeping Quality Supervisor. This role is essential in ensuring that our hotel rooms meet the highest standards of cleanliness and quality.Key Responsibilities:Oversee and mentor housekeeping personnelConduct...
-
istant Director Of Nursing
2 weeks ago
Queensbury, United States Quality Talent Group Full timeWarren Center is hiring a Assistant Director of Nursing (ADON) in Queensbury NY. DUTIES: Assist the DNS with management responsibilities and in maintaining the quality of care Responsible for Wound/Skin Rounds weekly Assist with compliance and ensure effective communication with all levels of nursing staff Meet the nursing medical needs of all...
-
Assistant Director of Nursing
3 weeks ago
Queensbury, United States Quality Talent Group Full timeJob DescriptionJob DescriptionWarren Center is hiring a Assistant Director of Nursing (ADON) in Queensbury, NY. DUTIES: Assist the DNS with management responsibilities and in maintaining the quality of care Responsible for Wound/Skin Rounds weekly Assist with compliance and ensure effective communication with all levels of nursing staff Meet the nursing...
-
Registered Nurse Supervisor Overnights
2 weeks ago
Queensbury, United States Quality Talent Group Full timeGlens Falls Center is hiring a Registered Nurse (RN) Supervisor Overnight in Glens Falls NY. Duties: Complete resident care requirements by scheduling and assigning nursing staff Establish a compassionate environment by providing support to residents & families Provide information to residents & staff by answering questions and requests Maintain a...
-
Housekeeping Quality Control Supervisor
3 weeks ago
Queensbury, New York, United States Home2 Suites, Queensbury Full timeOverview of the Housekeeping Inspector RoleWe are a hospitality organization seeking a committed individual to fulfill the role of Housekeeping Inspector. This position is crucial for ensuring that our hotel rooms meet the highest standards of cleanliness and quality.Key Responsibilities:Oversee and mentor housekeeping personnelConduct inspections of guest...
-
Nursing Department Manager
7 days ago
Queensbury, New York, United States Quality Talent Group Full timeAssistant Director of Nursing OpportunityWarren Center is seeking a skilled and experienced Assistant Director of Nursing to join our team in Queensbury, NY.Key Responsibilities:Assist the Director of Nursing in managing responsibilities and maintaining the quality of care.Conduct weekly wound/skin rounds to ensure resident well-being.Collaborate with...
-
Nursing Department Manager
1 week ago
Queensbury, New York, United States Quality Talent Group Full timeAssistant Director of Nursing OpportunityWarren Center is seeking a skilled and experienced Assistant Director of Nursing to join our team in Queensbury, NY.Key Responsibilities:Assist the Director of Nursing in managing responsibilities and maintaining the quality of care.Conduct weekly wound/skin rounds to ensure resident well-being.Collaborate with...
-
Senior Associate, Tax and Advisory Services
5 days ago
Queensbury, New York, United States CMJ, LLP Full timeAbout the RoleCMJ, LLP is seeking a highly skilled Tax Professional to join our team as a Senior Associate. As a key member of our tax department, you will be responsible for providing expert tax advice and guidance to our clients.Key ResponsibilitiesPrepare complex tax returns for individuals, corporations, and partnerships.Act as a resource for tax staff,...
-
Senior Associate, Tax
3 weeks ago
Queensbury, United States CMJ, LLP Full timeCMJ is not your typical accounting firm. We are a cohesive team offering a full scope of services and solutions to drive the success of our clients’ businesses. We work as advisors to management teams, providing sound, informed feedback that contributes to growth and long-term stability.CMJ was founded in 1988, by Paul Curtis and Bill Jeffreys with a...
-
Director Of Social Work
2 days ago
Queensbury, United States Quality Talent Group Full timeWarren Center is hiring a Director of Social Work(DSW) or Director of Social Services in Queensbury NY.DUTIES: Directsestablishes & plans the overall policies/goals for the SocialServices Dept Responsible for assessmentscare planning & helping residents adjust Supervision of Department Staff DischargePlanning at start of admission ...
Senior Quality Assurance Manager
4 months ago
POSITION SUMMARY
Responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable national and international regulations and standards.
Responsible for Quality oversite of the day-to-day medical device manufacturing activities including supplier control oversite, incoming and in-process quality inspection, NCR/CAPA/Complaint review approval and product release. Provides direct tactical Quality support for multiple projects within Delcath Systems, Inc. to provide execution of the development, launch and post-approval maintenance of medical device components and finished medical devices according to the approved Design Control procedures.
This position retains signatory authority for Quality Management.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- In coordination with Senior Director of Quality, develops and executes quality and regulatory strategies and systems to comply with Quality System Regulations (QSR), Medical Device Directive (MDD), International Standards Organization (ISO), Recognized Consensus Standards and all other applicable quality system requirements. Ensures compliance to 21 CFR Part 820, 21 CFR Part 211, 21 CFR Part 4, ISO 13485, MDR 2017/745, UK MDR 2002, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
- Manages and maintains the effectiveness of the Delcath Quality Management System at the Queensbury sites and manages the resolution of all quality concerns and related issues as required. Acts as the Deputy Management Representative for Queensbury.
- Executes day-to-day processes for medical device manufacturing facility QA accountabilities to ensure continual regulatory compliance with FDA, Outside US Regulatory Authorities, and Notified Body and Approved Body requirements.
- Provides oversight for product releases: finished products, raw materials, packaging components, and labeling.
- Supports the Corrective Action and Preventive Action Program.
- Supports the Internal Audit Program through the performance of audits as required.
- Supports the Supplier Quality Program and perform on-site quality audits, as required.
- Supports Customer Complaint investigations. Ensure Customer Complaint records are properly maintained, followed-up, and closed.
- Supports the Routine Metric Review and the Management Review process to monitor and evaluate Quality System effectiveness.
- Maintains current knowledge base of all regulatory and quality assurance related changes within the industry.
- Provides Quality leadership to development teams. Represents the Quality discipline by providing support to all Sustaining Engineering Projects.
- Works closely with internal regulatory staff and external consultants to prepare, review medical device manufacturing documentation for domestic and international paper-based and electronic regulatory submissions.
- Collaborates with the Regulatory Team to recommend and implement regulatory strategies for product line extensions in support of product development team efforts and provide guidance to those teams to ensure that development activities are consistent with overall regulatory strategy.
- Reviews and interprets technical and scientific data to ensure regulatory requirements are met; evaluates product/design and process changes for potential effect upon product safety and effectiveness; appropriately document Quality disposition of such changes.
- Reviews and maintains Quality Systems programs to ensure continuous improvement and regulatory compliance.
EDUCATION and/or EXPERIENCE
A minimum of Bachelors degree in engineering or physical sciences.
A minimum of five or more years of experience in quality assurance, quality engineering, or related functions in a FDA regulated industry or ISO certified organization is required. In addition, a minimum of three or more years' experience as a direct supervisor/manager of Quality Professionals.
Must be team oriented, with the ability collaborate with diverse cross-functional teams.
Must possess strong analytical and process skills, and be computer proficient in Minitab, EXCEL, Word, etc.
Must possess strong verbal and written communication skills.
Must be an effective leader of the Quality team to ensure goals are established and monitored and must provide input and direction to team members to ensure issues are addressed in a timely manner and project status is communicated across the organization.
