Sr. Quality Management Systems Engineer # REF1965A
Found in: Resume Library US A2 - 2 weeks ago
As a Senior Quality Management System (QMS) Engineer in the medical device sector, you will play a vital role in overseeing the development, implementation, and maintenance of our Quality Management System. This position requires a deep understanding of industry-specific regulations and standards such as ISO 13485, FDA 21 CFR Part 820, and the European MDR. Your expertise will be instrumental in ensuring our products consistently meet the highest quality and safety standards, thus maintaining our commitment to excellence in the healthcare industry. You will be accountable for supporting the continued development, improvement, and expansion of the Quality Management System and maintaining compliance with regulations, standards, and Corporate requirements. You will be responsible for providing collaborative support to quality system leadership. You will work with other organizational functions, including Operations, Quality, R&D, procurement, corporate functions, regulatory agencies, and suppliers.
Principal Responsibilities
Conduct management review meetings to evaluate the effectiveness of the QMS, presenting data-driven insights on quality performance, audit outcomes, and more to top management.
Provide strategic recommendations based on management review findings to drive continuous improvement and reporting of review outcomes to relevant stakeholders.
Act as the primary liaison for all external audits (customer, registrar, etc.) and FDA inspections, ensuring all necessary documentation and processes are readily available and in compliance.
Lead and execute comprehensive internal audits to assess compliance with QMS requirements, ensuring consistent adherence to internal standards and regulatory guidelines.
Address and resolve any non-conformities identified during external and internal audits, implementing corrective and preventive actions to enhance the QMS and maintain regulatory compliance.
Lead the initiation, investigation, and resolution of Corrective and Preventive Actions (CAPAs), ensuring thorough data analysis, RCA tools, and practical solutions to prevent recurrence while maintaining alignment with quality system and regulatory requirements.
Regularly update QMS documentation to reflect changes arising from CAPA investigations and ensure continuous compliance with evolving quality system standards and regulatory requirements.
Assist in drafting customer quality agreements and program manufacturing/ quality plans.
Oversee and manage unit-level quality processes using advanced Manufacturing Execution Systems (MES) like Factorylogix and Product Lifecycle Management (PLM) tools such as Siemens Teamcenter
Participates in Six Sigma improvement projects, including coaching and development of employees.
-
Sr. Supplier Quality Engineer
Found in: Resume Library US A2 - 2 weeks ago
Merrimack, New Hampshire, United States Elbit Systems of America Full timeJob Description Primary Purpose: The Senior Supplier Quality Engineer drives customer satisfaction and continual improvement in accomplishing ESA’s strategic plan through monitoring, managing and resolving issues related to Supplier quality performance. The Senior SQE is proficient in developing Supplier relationships, auditing Supplier’s...
-
Systems Engineering Manager
Found in: Resume Library US A2 - 5 days ago
Merrimack, New Hampshire, United States Elbit Systems of America Full timeJob Description Scope The Manager, Systems Engineering will be responsible for leading a team of engineers in executing systems design and requirements analysis, systems development, modeling and simulation, systems engineering and analysis, and systems test and evaluation. This position is expected to provide guidance and management of a team,...
-
Sr. Quality Management Systems Engineer #
6 days ago
Merrimack, United States CareerBuilder Full timeJob Description As a Senior Quality Management System (QMS) Engineer in the medical device sector, you will play a vital role in overseeing the development, implementation, and maintenance of our Quality Management System. This position requires a deep understanding of industry-specific regulations and standards such as ISO 13485, FDA 21 CFR Part 820, and...
-
Sr. Engineering Technician-Electrical Medical Device
Found in: Resume Library US A2 - 7 days ago
Merrimack, New Hampshire, United States KMC Systems Full timeJob Description You will provide an advanced level of technical assistance with the design, development, construction, and testing of developmental prototype products, transition of pilot products to manufacturing, general electro/mechanical activities, test systems documentation, design, development and execution, and general research design, development...
-
Sr Manager Quality Engineering
5 days ago
New York, United States CareerBuilder Full timeSummary of Objective: The Sr. Quality Engineer Manager will manage a team of Quality professionals to provide Quality Engineering, Quality Systems, and Calibration support for Site Quality and Operations in regards to the manufacturing and packaging of pharmaceutical and medical device products. This position is responsible for site level administrative...
-
Sr Quality Manager with Security Clearance
Found in: Dice One Red US C2 - 6 days ago
Merrimack, United States BAE Systems Full timeJob Description You don't see it, but it's there. Our employees work on the world's most advanced electronics - from saving emissions in the City of Lights to powering the Mars Rover to protecting the F-35 fighter jet. At Electronic Systems, you'll be among the brightest minds, working on the aerospace and defense industry's most difficult problems. Drawing...
-
Project Engineering Manager – Medical Device
Found in: Resume Library US A2 - 2 weeks ago
Merrimack, New Hampshire, United States KMC Systems Full timeJob Description The Project Engineering Manager (PEM) is responsible for the planning and tactical execution of the engineering content of an assigned project. The PEM plans, schedules, and manages the Engineering content on projects for new product development, sustaining and upgrade projects for existing products. New product development includes projects...
-
Senior Software Development Engineer in Test
Found in: Resume Library US A2 - 2 weeks ago
Merrimack, New Hampshire, United States KMC Systems Full timeJob Description Responsibilities: Design, implement, and deliver reliable, high quality, robust automation software and/or software tools targeted for testing complex medical instruments to meet regulatory standards Create, maintain and review testing project documents including tool development plans and software tool validation plans Drive software...
-
Principal Software Development Engineer in Test
Found in: Resume Library US A2 - 7 days ago
Merrimack, New Hampshire, United States KMC Systems Full timeJob Description Principal Software Development Engineer in Test Responsibilities: Design, implement, and deliver reliable, high quality, robust automation software and/or software tools targeted for testing complex medical instruments to meet regulatory standards Create, maintain and review testing project documents including tool development plans...
-
Software Development Engineer in Test II
Found in: Resume Library US A2 - 2 weeks ago
Merrimack, New Hampshire, United States KMC Systems Full timeJob Description Responsibilities: Design, implement, and deliver reliable, high quality, robust automation software and/or software tools targeted for testing complex medical instruments to meet regulatory standards Create, maintain and review testing project documents including tool development plans and software tool validation plans Drive software...
-
Systems Admin Sr with Security Clearance
Found in: Dice One Red US C2 - 2 weeks ago
Merrimack, United States BAE Systems Full timeJob Description You don't see it, but it's there. Our employees work on the world's most advanced electronics - from saving emissions in the City of Lights to powering the Mars Rover to protecting the F- 35 fighter jet. At Electronic Systems, you'll be among the brightest minds, working on the aerospace and defense industry's most difficult problems. Drawing...
-
Supplier Quality Manager II
Found in: Dice One Red US C2 - 5 days ago
Merrimack, United States BAE Systems Full timeJob Description You don't see it, but it's there. Our employees work on the world's most advanced electronics - from saving emissions in the City of Lights to powering the Mars Rover to protecting the F-35 fighter jet. At Electronic Systems, you'll be among the brightest minds, working on the aerospace and defense industry's most difficult problems. Drawing...
-
Sr Quality Assurance Engineer
7 days ago
New York, United States Moog Full timeMOOG Space and Defense Senior Quality Assurance Engineer Moog Space and Defense Group- Actuation and Avionics Business Unit is recruiting for a Sr. Quality Assurance Engineer to join the team in East Aurora. The Sr. Quality Assurance Engineer has sole responsibility for the planning, implementation, and administration of Quality Programs to assure that a...
-
Staff Electrical Engineer-Medical Device Development
Found in: Resume Library US A2 - 7 days ago
Merrimack, New Hampshire, United States KMC Systems Full timeJob Description In this role, you will be responsible for leading the specification, architecture, and design of electrical and electronic hardware for complex medical instruments in a multi-disciplinary environment. You will have the opportunity to work on a diverse set of product development efforts. This is a highly advanced level and/or lead position...
-
Systems Engineering Lead with Security Clearance
Found in: Dice One Red US C2 - 7 days ago
Merrimack, United States BAE Systems Full timeJob Description See what you're missing. Our employees work on the world's most advanced electronics - from detecting threats for F-35 pilots to illuminating the night for soldiers. Spanning air, land, sea, and space, we are developing the technology of tomorrow, delivered today. Drawing strength from our differences, we're innovating for the future. And you...
-
Quality Engineer
Found in: Dice One Red US C2 - 2 weeks ago
Merrimack, United States BAE Systems Full timeJob Description What is it like working for Integrated Survivability Solutions product line (ISS) within the Countermeasure and Electromagnetic Attack Solutions (CEMA) business area?Impactful - take a look at some of the products we support:https://www.baesystems.com/en-us/productfamily/countermeasure-and-electromagnetic-attack-solutions Because of the need...
-
Operations Program Manager – Medical Device
Found in: Resume Library US A2 - 2 weeks ago
Merrimack, New Hampshire, United States KMC Systems Full timeJob Description The Operations Program Manager (OPM) will act as the main point of contact between KMC and our customer, focused specifically on the build to print and sustaining activities within operations. Included scope for this Program Manager includes managing transitional efforts for new product introduction, and the planning and execution of...
-
Sr. Network Engineer
7 days ago
Merrimack, United States CareerBuilder Full timeSr. Network Engineer Hybrid onsite role (3 days onsite, 2 days remote) Must have extensive experience Cisco Networking Other core skills Must be able to explain recent F5 load balancing experience in detail. Must be able to explain recent experience with Cisco switches (Catalyst and Nexus) in detail. Spyglass Partners, LLC has over 15 years' experience as a...
-
New York, United States Epic Systems Corporation (Wisconsin) Full timeJob Title: Sr. Systems Engineer with devops--Active secret clearance Work Location: Dulles, VA Senior Systems Engineer to assess, design, and develop automated cloud-based requirements and architectures and develop derived requirements and systems engineering artifacts into advanced cloud infrastructure, management, and operations. Responsibilities...
-
Principal Opto-Mechanical Engineer
Found in: Resume Library US A2 - 7 days ago
Merrimack, New Hampshire, United States Elbit Systems of America Full timeJob Description Job Description This is an exciting opportunity for a Mechanical Engineer to join Elbit America’s Electronics Systems Division. The Mechanical Engineering will work on advanced programs, providing unique and technically advanced engineering development products to the US Government. You will be the technical lead for a group of 4+...