Quality Manager: Medical Devices & Regulatory Excellence
Balda-C-Brewer
Balda-C-Brewer is looking for a Quality Manager in New York to oversee the quality department and ensure compliance with ISO 9001, 13485, and FDA regulations. The role involves developing quality management systems, leading audits, and managing customer complaints. The ideal candidate will have a Bachelor’s degree, at least 5 years of experience in quality systems, and strong leadership skills. Additional skills in metrology and Six Sigma are preferred. #J-18808-Ljbffr
- ...team, the Clinical Operations Quality Manager will oversee and execute... ..., R&D, Program Management, Regulatory Affairs, Legal, Marketing,... ...for a sponsor or CRO in the medical device industry. Experience developing... ...manage CAPA when required. Excellent oral and written...RegulatoryMedical deviceContract workRemote work
$140k - $180k
...Full Time Management Ontario, CA, US 10 days ago Requisition... ...maintain a compliant quality management system by... ...820 regulations for medical devices with a continuous... ...specifications) and regulatory requirements Lead customer... ...skills. Excellent English communication...RegulatoryMedical deviceFull timeWork experience placementLocal areaShift work- ...Developing and maintaining quality and regulatory systems and system... ...conformity with domestic medical device agency regulations and requirements... ...coordinator, including: Managing data within the UDI spreadsheet... ...management skills, excellent interpersonal, verbal, and...RegulatoryMedical deviceWork experience placement
- ...medicine space. They’re looking for a hands‑on QA/RA Manager to take ownership of Quality and Regulatory operations across the organization. If you thrive... ...’re Looking For 5+ years of QA/RA experience in medical device manufacturing Proven knowledge of 21 CFR Part 820...RegulatoryMedical device
- ...manufacturer investing heavily in quality, compliance, and operational excellence . They’re hiring a... ...the site Quality Management System (ISO 9001 / 1348... ...in pharma, biotech, or medical device manufacturing Deep expertise... ...QMS, audits, CAPA, and regulatory compliance Strong track...RegulatoryMedical device
$117.77k - $161.93k
...Strategic Business Process Manager, Product Delivery Excellence-remote within the US... ...deliver compliant, high-quality, and innovative products... ...Business Line leaders, Quality/Regulatory, and cross-functional... ...3+ years in the medical device industry* Proven experience...RegulatoryMedical deviceTemporary workLocal areaRemote work- ...Group is seeking an experienced candidate to develop and maintain quality and regulatory systems in compliance with medical device regulations. This role involves collaborating with teams and managing supplier controls, along with supporting various quality assurance...RegulatoryMedical device
$110k
...animals through customized medication and compassionate care... ...driven by purpose, quality, and a shared... ...are seeking a Quality Manager to join our team. In this... ...Assist in leading all regulatory inspections of the site... ...biotech/biopharma/medical device/pharma industry 7+...RegulatoryMedical deviceFull timeContract work- ...Director / Director IT Quality & Compliance... ...supportive teams and excellent career progression reflected... ...and corporate data is managed to a set standard.... ...Representing us in client and regulatory audits of GCP... ...pharmaceutical, biotechnology, medical device or CRO industry, with...RegulatoryMedical deviceContract workShift work
- 100 Merit Medical Systems, Inc. is seeking a leadership position in post market surveillance with deep regulatory expertise. The ideal candidate will have a Bachelor's degree and 15... ...in leadership roles within the medical device sector. The role involves establishing...RegulatoryMedical deviceShift work
- Quality Control Supervisor - Night Shift Astrix is proud to partner... ..., biotechnology, medical device, or clinical laboratory environments... ..., training, performance management, and productivity oversight... ...in compliance with cGMP and regulatory requirements Coordinate laboratory...RegulatoryMedical devicePermanent employmentContract workLocal areaShift workNight shiftRotating shiftWeekend work
$195.3k - $227.85k
Associate Director, Clinical Quality Assurance Auditor... ...standards and regulatory compliance culture at... ...a proven ability to manage multiple complex projects... ...Cytokinetics.This is an excellent opportunity to help... ...in pharma/biotech or medical device industries, with a...RegulatoryMedical deviceContract workLocal areaRemote work- ...Quality Manager Location: Northern - Greater Pittsburgh area. Salary: $60,000 - $70,000. Great... ...process control, supplier performance, and regulatory compliance. This position reports to... ...Program Paid Vacation & Sick Time Medical, Dental, Vision, Life (paid fully by employer...RegulatoryPermanent employmentWork at officeFlexible hours
- ...Calyxo is seeking a Procedural Excellence Manager, based remotely in the USA, to develop and maintain best practices for kidney stone treatment... .... Qualified candidates will need at least 5 years in the medical device industry, a relevant bachelor's degree, and strong...Medical deviceRemote work
- ...seeking an accountable and specialized Manager of Regulatory Affairs & Quality Assurance to lead our compliance... ...lifecycle of PPE, including medical‑grade masks and gowns. You will have... ...with NIOSH for respiratory protective devices, such as N95 respirators. Ensure materials...RegulatoryMedical device
- ...This remote role involves managing development, design, and... ...for drug delivery devices. The successful candidate will need substantial medical device development experience, excellent leadership skills, and the... ...timelines, as well as ensuring regulatory compliance. Join Kaléo...RegulatoryMedical deviceRemote work
$60 - $62 per hour
...Consulting, Inc is seeking a talented Engr 2 for a quality-focused role. This is an 08-month remote... ...possess strong skills in quality documentation, regulatory compliance, and advanced data analysis using Power BI and Excel. The role involves contributing to quality...RegulatoryMedical deviceRemote jobHourly payContract work- A leading regulatory consultancy located in New Jersey is seeking an experienced Regulatory... ...adherence to regulations concerning medical devices. The ideal candidate should have over... ...of experience in Regulatory Affairs, excellent knowledge of relevant global regulations...RegulatoryMedical deviceWork at office
- ...professional to support product quality, color, and compliance... ...ensures products meet brand, regulatory, and safety standards while driving... ...with product standards Manage corrective action plans and track... ..., Sam’s Club) Proficiency in Excel, ERP systems, and PowerPoint...Regulatory
- ...Impact Frida is seeking a Global Regulatory Manager (Contractor) to join our Quality and Regulatory team based in... ...the laws regulating the CPG and medical device industries globally. The right person... ...& priorities constantly change Excellent written and verbal communication...RegulatoryMedical deviceContract workTemporary workFor contractorsWork at officeLocal areaImmediate startRemote work
$85k
...aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. Understand and... ..., preferably in the medical device or surgical sales industry. Strong... ...in a fast‑paced environment. Excellent organizational and time‑management...RegulatoryMedical device- ...alert: Senior Director, Regulatory Affairs Date: May 23,... ...and providing management support for the US development... ...timely, high-quality submissions to focus... ...strong expertise in the Medical Device area, and the ability... ...duties as assigned. • Excellent verbal and written communication...RegulatoryMedical device
- .... Role Overview Area Sales Manager is responsible for developing... ...Responsible for all regulatory and institutional requirements... ...sales driven environment in the medical devices / Pharma industry with demonstrated... ...required from time to time Excellent interpersonal skills and...RegulatoryMedical deviceLocal areaWeekend work
- ...Microbiology, Chemistry) 7+ years of experience Regulatory Affairs required Support US and EU... ...of global regulations relevant to medical devices, Class II and/or Class III devices Solid... ...Office Suite including Word, PowerPoint and Excel #J-18808-Ljbffr Indotronix Avani GroupRegulatoryMedical deviceWork at office
$75k - $85k
...the area to quickly learn the medical device industry and Foot & Ankle... ...accounts, building of sets, managing inventory, and, as they learn... ...sales opportunities, deliver excellent customer service, and... ...understanding of the field to include regulatory compliance issues and adhere...RegulatoryMedical deviceLocal area$57.5k - $70k
...assesses product and regulatory pathways, evaluates intellectual... ...Develop high‑quality commercialization... ...technology commercialization. Excellent communication skills,... ...work independently, manage multiple projects,... ...in health‑tech, medical devices, biotechnology, digital...RegulatoryMedical deviceFull timeWork at office- ...pharmaceutical, biotech, and medical device organizations to address complex regulatory and operational... ...affairs, along with prior management consulting experience.... ...teams and ensure high‑quality, on‑time delivery of... ...client impact Excellent communication, presentation...RegulatoryMedical deviceFull timeRemote work
- ...professional in New York, NY to support product quality and compliance initiatives. The role entails ensuring products meet brand, regulatory, and safety standards while fostering... ...evaluation and proficiency in tools like Excel and ERP systems are required. #J-18808-Ljbffr...Regulatory
- ...organization in New York is seeking a Manager for Quality and Compliance. This role involves ensuring... ...while fostering a culture of excellence. Responsibilities include conducting program... ...a Master's Degree and experience in regulatory compliance within a non-profit context...RegulatoryLocal area
- Regulatory Affairs Specialist 12-month contract Remote CST hours (Local to Cary... ...in regulatory affairs within the medical device industry. Strong knowledge of U.... ...regulatory strategies and manage documentation remediation. Excellent communication, organizational, and...RegulatoryMedical deviceContract workLocal areaRemote work
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