-
Medical Device Quality Manager
2 weeks ago
Talent Groups Westborough, United States5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries. · Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FD ...
-
Medical Device Quality Engineer
1 week ago
Talent Group Westborough, United States5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries. · Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FD ...
-
Medical Device Quality Engineer
2 weeks ago
Talent Groups Westborough, United States5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries. · Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FD ...
-
Quality Engineer Medical Device
3 weeks ago
Connexion Systems & Engineering Andover, United StatesJob Description · Job Description · Quality Engineer · ESSENTIAL FUNCTIONS INCLUDE BUT ARE NOT LIMITED TO: · Provide quality engineering support in the manufacturing of medical devices & hardware. · Ensure compliance of manufacturing processes and areas to all applicable quali ...
-
Senior Medical Device Quality Engineer
2 weeks ago
VulcanForms Devens, United StatesJob Description · Job DescriptionSalary: · About us · VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's ...
-
Senior Medical Device Quality Engineer
2 weeks ago
VulcanForms Inc. Devens, United StatesJob Description · Job Description Salary: · About us · VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's ...
-
Medical Device Software Quality Engineer
2 weeks ago
VulcanForms Inc. Devens, United StatesAbout us · VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal add ...
-
Associate Director, Device Manufacturing
2 weeks ago
Viridian Therapeutics, Inc Waltham, United States: · Reporting to the Vice President, Device Development & Commercialization, the Associate Director, Device Manufacturing will lead technical oversight of process development for assembly, packaging, labelling and functional testing of medical device/drug combination products. Th ...
-
Orthopaedic Technician
2 weeks ago
Massachusetts General Hospital(MGH) Waltham, United States**Orthopaedic Technician (Waltham, MA)** · Under the general supervision of the Administrative Manager and the Manager of Orthopaedic Technicians, this position is responsible for providing Orthopaedic services to patients in a busy Ambulatory Clinic. This position will help supp ...
-
Director, External Manufacturing
3 weeks ago
Viridian Therapeutics, Inc Waltham, United States: · At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-dri ...
-
Engineering Technician
3 weeks ago
A123 Systems LLC Waltham, United States**Position**: Engineering Technician - Electrode test and Cell Assembly · **Location**: Waltham, MA · Position Overview The Engineering Technician will work under the direction of the Electrode Lab Supervisor. Primary responsibilities of this position include operating manufactur ...
-
Physical Therapy Assistant
2 weeks ago
Mass General Brigham Healthcare at Home Waltham, United States**Physical Therapy Assistant (PTA)** · Mass General Brigham Home Care, an affiliate of Mass General Brigham, is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as ...
-
Reagent Packager I
2 weeks ago
Nova Biomedical Waltham, United StatesNova Biomedical is hiring a **Reagent Packager **in our** Waltham, MA **facility on the **Second Shift (3:00 PM - 11:30 PM - This includes a 10% Shift Differential)**. The Reagent Packager will be responsible for packaging and building reagent and control kits per Assembly Proced ...
-
Reagent Packager I
2 weeks ago
Nova Biomedical Waltham, United StatesNova Biomedical is hiring a **Reagent Packager **in our** Waltham, MA **facility on the **First Shift (6:45 A.M - 3:15 P.M.)**. The Reagent Packager will be responsible for packaging and building reagent and control kits per Assembly Procedure (AP). Other responsibilities include ...
-
Medical Device Software Quality Engineer
1 week ago
VulcanForms Devens, United StatesJob Description · Job DescriptionSalary: · About us · VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's ...
-
Director, Corporate Counsel
1 week ago
Thermo Fisher Scientific Waltham, United StatesThermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences researc ...
-
Technical Account Manager
2 weeks ago
Ansys Waltham, United States**Requisition #**: 13527 · **Our Mission: Powering Innovation That Drives Human Advancement**: · When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys s ...
-
Patient Care Coordinator
2 days ago
Diamond Dynamics Waltham, MA, United States Freelance**Patient Care Coordinator (m/f/d) part-time in Waltham, MA**: · Löwenstein Medical SE & Co. KG · Sleep-Apnea-Center Munich; Prosomno · Experience · Part-time · **Why Löwenstein Medical?**: · **Taking new paths.** But never forgetting where we come from. For over 30 years, Löwens ...
-
Training Specialist
8 hours ago
AbbVie Waltham, United States**Company Description** · Purpose · The Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of supp ...
-
Quality & Regulatory Project Manager
2 weeks ago
Exergen Corporation Watertown, United States_**Exergen Corporation**_ _is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever pre ...
Medical Device Quality - Waltham, United States - Client of Nachman BioMedical
Description
Great QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing devices for clinical and consumer settings. The experienced and successful QA/RA Project Manager in this new role will report to the VP of QA/RA and work with a cross functional team to assure all aspects of a new product line's compliance with all Regulatory, Clinical and QA technical, clinical and marketing requirements.
Key Responsibilities and Activities
The experienced and successful QA/RA pro in this role will work with a cross functional team to assure compliance with technical, clinical and marketing standards.
Develop and manage product line release plans and databases that include milestones and Timelines, and continuous maintenance records.
Liaise with cross-functional departments for preparation of documentation for submission of applications (MDD to MDR) to EU Notify Body.
With the VP to drive the clinical portion of the product line on patient recruitment strategies, operational feasibility and implementation of study objectives. Manage study documents, and maintain knowledge of the data, information, and formats required for regulatory applications.
Review and comment on data from contributing departments to ensure accurate and complete documents for inclusion in regulatory standards (UDI, IFU, Labeling, Packaging, Marketing) docs.
Serve as a key member of the matrix regulatory team; contribute to the generation and review of regulatory strategy documents, and generation of meeting agenda and minutes.
Independently manage interactions with clinical monitors, data management, safety, regulatory, and QA team members, both internally and externally in mitigations to the product release.
Work with departmental leaderships to maintain and continuously improve ISO 9001, et al.
Participate in the CAPA Review Board, internal and external audits, and training program. Make recommendations for corrective action necessary to ensure conformity with quality specifications.
Participate in cross-functional teams focused executing regulatory strategy.
Contribute to improvement/development of policies, procedures (RA SOPs), and best practices for regulatory submissions and approvals in multiple countries.
Assist in managing the regulatory information management system (RIMS) and support the Quality function with the implementation of a new eQMS and in updating the current processes within QMSR.
Required Education and Experience
BS or MS in a scientific discipline.
Minimum of 7-10 years of direct experience in medical device QA and RA including project leadership.
Strong knowledge of FDA 510 (k) and international regulatory requirements, GMP and GCP regulations, and Medical Device product requirements.
Experience with clinical data release operations.
Ability to find creative solutions to issues impacting timelines and budgets.
Working experience with CAPAs; exposure to audits is a plus.
Well organized with detail & deadline orientation.
Strong leadership, facilitation, and interpersonal skills, with the ability to interact with staff on all levels and thrive in a fast paced environment.
Excellent verbal & written communication skills.
Proven organizational skills and demonstrated problem-solving capabilities.
Able to work independently with minimal supervision.
&v=024){kind=logo}
