Medical Device Quality Director: Catheter & Compliance
EPS Connects LLC
A growing technology-driven medical device manufacturer is seeking a Manufacturing Quality Director with extensive experience in overseeing quality functions and ensuring regulatory compliance. This role will lead initiatives in catheter assembly processes and drive quality improvements across the organization. The ideal candidate should have a deep understanding of ISO 13485 and FDA regulations, along with strong leadership skills to develop cross-functional teams. #J-18808-Ljbffr EPS Connects LLC
- ...care for durable medical equipment manufacturers... ...access to quality medical equipment... ...pain, nerve block catheters, postoperative pain... ...central venous access devices, closed system transfer... ..., Quality and Compliance provides strategic... ...the VP/Sr. Director level. COMPREHENSIVE...Medical deviceWork at officeLocal areaFlexible hours
- Eight Sleep is seeking a Director of Regulatory Affairs and Quality Assurance to lead risk management and oversee the quality management system. You’ll... ...Francisco. You’ll drive regulatory submissions, ensure compliance with ISO 13485 and ISO 14971, and shape the company’s...Medical device
- AbbVie is seeking a senior regulatory/compliance leader to oversee supplier quality and compliance across worldwide requirements. You will evaluate external... ...meets GMP, GLP, GCP, GDP standards in the medical device and drug development space. In this role you will collaborate...Medical deviceWorldwide
- Alltrista - Director, Quality Systems & Regulatory Affairs Greer, SC, USA... ...include Consumer Products, Medical/Healthcare, Personal Care, Health... ...be responsible for ensuring compliance with regulatory requirements... ...Affairs within the medical device industry. In-depth...Medical deviceWorldwide
- ...our Pod platform to detect medical conditions and to provide... .... We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a... ...multiple submissions Oversee compliance and documentation... ...quality functions for medical devices Successful track record...Medical deviceFull timeImmediate startWorldwideFlexible hoursNight shift
- Capper Foundation in Topeka, KS seeks a Quality Director for Adult Services. The role leads development, implementation, and monitoring of... ..., collaborating with leadership to ensure timely documentation and regulatory compliance. #J-18808-Ljbffr Capper Foundation
- Overview The Manufacturing Quality Director will provide strategic and... ...product integrity, regulatory compliance, and operational excellence in a fast-paced, high-mix medical device environment. This role... ...with a specific emphasis on catheter assembly and complex subassemblies...Medical deviceFull timeRelocationRelocation package
- ...technical, validation, and quality expertise across every stage... ...pharmaceutical, biotech, and medical device organizations to navigate complexity... ...maintain a strong state of compliance and audit readiness. Our... ...-hire position: Quality Director ABOUT THE ROLE The Quality...Medical deviceContract workWork at office
$145k - $205k
...initiatives that support global compliance and timely patient access to... ...to products, processes, and quality systems; and recommend risk‑... ..., as assigned, including FDA device listings, establishment registrations... ...technical discipline. Medical device, pharmaceutical, or...Medical deviceWork experience placementWork at officeWorldwide- ..., LLC in Kentucky is seeking a hands-on Quality Manager to lead our ISO 13485 Quality Management System within a fast-paced medical device packaging operation. You will partner with... ...Chain and Customer Service to ensure compliance, drive continuous improvement, and maintain...Medical device
$170k - $185k
...approval of new in vitro diagnostics and medical devices into the worldwide market, as directed.... ..., and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR,... ...regulatory agencies. Advanced knowledge of quality systems and good manufacturing...Medical deviceWork experience placementWork at officeLocal areaRemote workWorldwideHome officeNight shift- ...Tremendous opportunity for an experienced Quality Manager to join this established and... ...personnel, take ownership of regulatory and compliance quality related matters and similar.... ...aerospace, automotive, semiconductor, medical device or similar) Strong knowledge of Six...Medical deviceRelocation package
- ...Description Quality Manager | ISO 13485 Medical Device Manufacturing We are seeking a hands-on Quality Manager who can lead and continuously improve our... ..., Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence...Medical device
- Arcutis Biotherapeutics, Inc. is seeking a Senior Director, Supplier Quality to establish and manage a risk-based supplier program ensuring GMP, GDP, and regulatory compliance, protecting product quality and patient safety. The role leads a team of supplier quality professionals...
- Pulmovant is seeking a Director, CMC Quality to provide quality oversight of external vendors and ensure cGMP compliance across drug substance, drug product, and finished dosage forms in a global clinical program. This hands-on role requires strategic yet practical quality...
$139k - $173k
...B. Braun Medical Inc., a leader in infusion therapy and pain management... ...B. Braun as Manager III, Quality Control and lead a Chemistry... ...product quality, regulatory compliance, and operational excellence.... ...within a pharmaceutical, medical device, or regulated manufacturing...Medical deviceWork at officeShift work- ..., ancestry, color, family or medical care leave, gender identity or... ...and ordinances. Job Title: Quality Manager Location : Lincolnshire... ...qualityassurance,and compliance functions and ensures integration... ...conform to validated processes and Device Master Records, as well as...Medical device
$149k - $248.3k
...Regulatory Affairs team that plays a critical role in ensuring compliance and supporting Dexcom’s international growth. We’re... ...problem-solving, and making a positive impact in the fast-paced medical device industry. Our team thrives on innovation, teamwork, and a little...Medical deviceRemote workWorldwideHome officeFlexible hours$122.25k - $176.58k
...advertising and promotional compliance matters. About Sanofi We're an... ...Committees (RC) for commercial and medical materials, respectively.... ...pharmaceutical or medical device advertising and promotional review... ...benefits including high-quality healthcare, prevention and wellness...Medical deviceWork experience placement- Sentara Medical Group in Virginia Beach is seeking a Site Chief Hospitalist for Sentara Virginia Beach General Hospital. This 1.0 FTE role combines two leadership positions: Medical Director of Quality, Regulatory & Safety (50%) and Chief Hospitalist (50%). The Medical...
$102.1k
...As the Quality Systems Manager supporting Management Control and CAPA processes, you... ...responsible for driving effectiveness, compliance, and continuous improvements across the... ...quality engineering experience in the medical device or pharmaceutical industry Experience with...Medical deviceHourly payWork at officeLocal areaRelocation packageShift work3 days per week$95k - $145k
Position Summary Drive validation and compliance activities for complex GxP systems as a... ...attention to detail and quality of work productAbility to build and sustain... ...environment, including pharma, biotech, medical device, or clinicalExperience leading validation...Medical deviceRemote workVisa sponsorship- At Capstan Medical, we’re building one of the most exciting and innovative... ...combines surgical robotics, catheter-based delivery, and next-... ...processes, ensuring compliance with regulatory requirements... ...including FDA guidelines for medical device development, is a plus....Medical deviceWork at officeFlexible hours
- Description The Quality Manager leads continuous improvement, Lean Six Sigma execution, structured problem solving, and operational... ...electromagnetic fields (EMFs) may affect certain implanted medical devices. We are committed to providing a safe workplace. If you believe...Medical deviceWork at office
- ...client, is seeking Associate Territory Managers for entry-level medical device sales. You will cover outpatient urology and urogynecology... ...and clinic staff while driving prescriptions of intermittent catheters and Urinary Management Systems. You will not inherit a book of...Medical device
- ...seeking an Associate Territory Manager to begin a career in medical device sales. This field-based role targets outpatient urology clinics... ...physicians and staff to drive prescriptions for intermittent catheters and Urinary Management Systems. You will build your own...Medical device
- ...needed to set our team members up for success. Summary The Quality Manager serves as the designated Quality Management Representative... ...aspects of the Quality System within our chemical mixing / medical device manufacturing operation. This role has responsibility for...Medical deviceWork at office
- Description Manage QMS compliance with the appropriate internal and external regulatory requirements... ...as appropriate. Own the development of Quality Metrics, and coordinate quality data... ...Minimum of 7 years of experience in a Medical Device environment, 3-5 years supervisory...Medical device
$81.65k - $112.7k
...external laboratories. The role ensures compliance with applicable FDA regulations, ISO 13... ..., GMP/GLP standards, and company quality system procedures while fostering a culture... ...GMP/GLP laboratory experience within the medical device, pharmaceutical, biotechnology, or...Medical deviceContract workTemporary workWork at office- ...Marmon Holdings, Inc. through MicroAire Surgical Instruments LLC is seeking a Principal Quality Assurance Engineer. This senior role leads QA for new medical devices and supports existing products, coordinating CAPA, audits, and supplier quality while mentoring QA staff...Medical device
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