Iso 13485 jobs in pennsylvania

Pennsylvania

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Today

Location: DeSales University, PA Salary: $160,000.00 USD Annually - $175,000.00 USD Annually Description: Job Title: BRM/ Engagement Manager Location: Center Valley, PA / Edison, NJ Employment: Fulltime Job Description Role The Engagement Manager will own and strengthen strategic customer relationships across business and IT functions within the United States. Key Responsibilities Strategic Account Leadership Own and strengthen strategic relationships with customer stakeholders across business

Full-time

USD 160,000.00 - 175,000.00 per year

Quality engineer

Reedsville, Pennsylvania

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24d ago

Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments. Key Resp

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Third Party, Contract

55 - 60

Quality engineer / Lead/ Manager - Medical Devices Manufacturing Experience

Reedsville, Pennsylvania

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22d ago

Role: Quality engineer / Lead/ Manager Medical Devices Manufacturing Experience Positions: 5 Openings Location: Reedsville, PA (Day 1 Onsite) Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield

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Contract, Third Party

Depends on Experience

VP, QA Franchise (Med Device)

Allentown, Pennsylvania

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Today

B. Braun Medical, Inc. Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Allentown, Pennsylvania, United States Functional Area: Quality Working Model: Hybrid Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 10833 B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutri

Full-time

USD 260,000.00 - 290,000.00 per year

Technical Project/Program Management - Technical Program Manager V

Remote

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Today

Job#: 3053591 Job Description: Technical Project/Program Management - Technical Program Manager V Compensation: $12- - $130 hourly Location: Remote, California (Remote) Role Overview We are seeking a senior Technical Program Manager with relevant Software as a Medical Device (SaMD) experience. This role focuses on managing the software release process for a key medical device feature. The position requires leading cross-functional teams to ensure deliverables are completed in accordance wit

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Full-time

$120 - $130 per hour

GRC Analyst

Remote

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3d ago

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Senior Manager IT Manufacturing Applications

Remote or San Diego, California

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 141,800.00 - 236,400.00 per year

Principal National Support Engineer II

Remote

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Today

Position Overview The Principal National Support Engineer II provides the highest level of technical expertise and experience to the Fujifilm Healthcare Medical Informatics business covering all currently offered products including, but not limited to: storage systems, PACS (Radiology/Cardiology), VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems. While this position primarily supports the Technical Assistance Center (TAC), technical leadership and direction is provided to all

Full-time

USD 110,366.00 - 130,909.00 per year

Sr CAPA Engineer

Remote or Waltham, Massachusetts

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Today

PURPOSE AND SCOPE: Lead the harmonization and standardization of the product transfer process including execution and oversight of the product transfer process for assigned regional/global area. PRINCIPAL DUTIES AND RESPONSIBILITIES: Develop, implement, and maintain Global Product Transfer processes for design and manufacturing product transfer.Ensure product quality is achieved at the receiving manufacturing site level during product transfer projectsPartner with CE vertical quality, R&D team

Full-time

Sr. Engineer, Product Cyber Security

Remote or Ashland, Oregon

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Today

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biol

Full-time

USD 117,800.00 - 188,600.00 per year

Senior Supplier Engineer-Ultrasound

Reedsville, Pennsylvania

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Today

Job Title Senior Supplier Engineer-Ultrasound Job Description The Senior Supplier Engineer is responsible for driving supplier performance and continuoprocess improvement by applying Advanced Product Quality Planning (APQP) processes, striving for continuous quality improvement throughout the product lifecycle, and ensuring regulatory compliance. Your role: Facilitates technical capability assessments of potential new suppliers, ensuring they meet the company's quality standards, and contribu

Full-time

USD 92,000.00 - 146,000.00 per year

Loftware Spectrum Technical Lead / Solution Engineer

Remote or Plano, Texas

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Today

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing s

Full-time

Imaging Service Engineer I - Minnesota

Remote

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Today

Position Overview An Imaging Service Engineer I is responsible for performing scheduled service work on systems within a service area, and some unscheduled work in the service area with the assistance of technical support, as directed by the Area Service Manager. Company Overview At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagno

Full-time

USD 32.69 - 38.46 per hour

Process Engineering Support Technician

Rector, Pennsylvania

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Today

Job Description Summary As a Process Engineering Support Technician you will support engineers in the design, implementation, maintenance, and continuous improvement of manufacturing processes, tooling, fixtures, and production equipment. Partners with engineering teams to support tooling release activities, preventive maintenance programs, and manufacturing documentation. Collaborates with internal and international teams on product, process, tooling, and troubleshooting initiatives. Provides a

Full-time

Senior Manager, Package Engineering

Audubon, Pennsylvania

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Today

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their li

Full-time

Process Engineer (Off Shift)

Mount Pleasant, Pennsylvania

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Today

Build what powers tomorrow-join Intervala, where advanced electronics manufacturing meets innovation, precision, and purpose. Intervala is seeking Off shift Process Engineers Schedule: Off Shift | Typically 1:00 PM-10:00 PM, 2:00 PM-11:00 PM, etc *Schedule can be somewhat flexible; we are looking for Process Engineers who can overlap with our 2nd shift production* What You'll Do As a Process Engineer, you will assist with establishing, maintaining, and improving manufacturing processes and s

Full-time

Device Engineer II

West Chester, Pennsylvania

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Today

We Are Teva We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportun

Full-time

CAD Designer

York, Pennsylvania

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Today

Requistion ID: 84300 Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality, a

Full-time

Sr Device Engineer

West Chester, Pennsylvania

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Today

Full-time

Process Engineer (Wire & Cable)

Mount Pleasant, Pennsylvania

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Today

Build what powers tomorrow-join Intervala, where advanced electronics manufacturing meets innovation, precision, and purpose. Process Engineer - Cable & Wire | 1st Shift We are seeking a Process Engineer - Cable & Wire to join our growing manufacturing team on 1st shift. This role will focus on developing, implementing, and continuously improving manufacturing processes for cable and wire assemblies, ensuring processes are efficient, repeatable, scalable, and capable of meeting customer qualit

Full-time

Iso 13485 jobs in Pennsylvania, USA