QA Leader, CQC-Q: Medical Device Validation & Transfer
Eli Lilly & Co
Eli Lilly and Company is looking for a Quality Assurance Representative in Indianapolis to ensure manufacturing process design compliance and support technical transfers for medical devices. The ideal candidate will have 5–7+ years of experience in Quality, demonstrate strong knowledge of regulations, and be able to lead QA initiatives. The position requires a Bachelor’s degree and offers comprehensive benefits. #J-18808-Ljbffr Eli Lilly and Company
$65.25k - $169.4k
...Commercialization (CQC-Q)Applylocations: US... ...global healthcare leader headquartered in... ...experience supporting medical device and combination... ...manufacturing, technical transfer, and contract... ...process design, validation, and manufacturing... ...Responsibilities*** Provide QA oversight for...CQCMedical deviceFull timeContract workH1bWork at officeVisa sponsorshipWork visaFlexible hours- ...FDA, ISO 13485, and other relevant regulatory standards for medical device manufacturing.Develop and implement quality management system... ...Develop and maintain quality documentation, including process validation protocols, technical reports, and device history records.Monitor...Medical deviceWork at office
$126k - $204.6k
...are a global healthcare leader headquartered in... ...Complaint Handling and Medical Device Reporting Processes. This... ...for improvement and/or transfer IDM best practices to... ...coach less-experienced QA Representatives and... ...design, manufacturing and validation; preferably device...Medical deviceFull timeWork visaFlexible hours- ...at least 3 years of experience in the Medical Device industry to support manufacturing operations... ...will be responsible for developing, validating, and improving manufacturing processes... ...new product introductions and process transfers .Prepare and maintain manufacturing...Medical device
$75k - $106k
...0 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated... ...in biotech or pharmaceutical environments preferred over medical device In-depth understanding of GAMP guidelines and FDA...Medical deviceWorldwide$126k - $204.6k
BioSpace is seeking a Director for the New Target Validation within Discovery Immunology, focused on developing biological strategies for... ...000 to $204,600, along with comprehensive benefits, including medical, dental, and a company-sponsored 401(k). #J-18808-Ljbffr...- Validation Engineering Roles page is loaded## Validation Engineering Roleslocations: Indianapolis... ...Human Leadership, we cultivate the leaders who will define tomorrow and partner... ...and/or facilities in pharmaceutical or medical device environments • **Sr. Validation...Medical deviceContract workWork at officeImmediate start
- ...pharmaceutical company is seeking a CQV Engineer - Process Owner to support device manufacturing projects. This role involves the commissioning... ...continuous improvements, and maintaining compliance with validation standards. The ideal candidate will have significant experience...
- A leading automation technology firm is hiring an RF Validation System Architect in Indianapolis, Indiana. This role involves defining architectural requirements and driving innovation in RF products. The ideal candidate will possess deep knowledge of RF standards, experience...
- ...logistics partner. This role involves ensuring distribution activities comply with GxP, FDA, and quality system requirements for medical devices. Responsibilities include vendor qualification, compliance monitoring, and serving as a liaison between the company and the 3PL...Medical device
$150 per hour
...our customers to provide the highest quality, life enhancing medical devices in the world. Work Schedule 7:00am-3:30pm Description This... ...Quality Personnel in the inspection department. Self-directed leader able to oversee Quality Inspector associates and daily tasks...Medical deviceLocal areaWorldwideShift work$80k - $100k
...Job Title: Quality Engineer Industry: Medical Device Manufacturing Responsibilities: Make sure production processes stay compliant... ...to make sure quality standards are met. Software validation activities - IQ, OQ, PQ CAPAs and root cause analysis...Medical device- ...services throughout the Defense, Aerospace, Medical Devices, and Commercial market segments. Our... ...teams to ensure effective information transfer that meets customer and organizational... ...development parts to test CNC programs and validate that they produce conforming parts....Medical device
$169.5k - $248.6k
.... We are a global healthcare leader headquartered in Indianapolis... ...central functions, GRA-CMC, GRA-Devices, and regional regulatory... ...delivery device and relevant medical devices) development, registration... ...details of any promotion or transfer of Lilly employees....Medical deviceFull timeLocal areaRelocationFlexible hours- Rehab Medical LLC is seeking an engineer to design and develop manufacturing processes for medical devices in Indianapolis. The ideal candidate will have a Bachelor's degree in Mechanical... ...Responsibilities include leading design transfer, troubleshooting manufacturing...Medical device
$76.5k - $167.2k
...global healthcare leader headquartered in Indianapolis... ...The Indy Device Manufacturing (IDM... ...qualification (C&Q) of the equipment.... .... Member of Validation COP and a liaison... ...Process, previous medical device manufacturing... ...any promotion or transfer of Lilly employees...Medical deviceFull timeContract workFor contractorsWork experience placementFlexible hours- ...liaison between development and the various Medical Informatics departments. Lead Enterprise... ..., and actively participate in knowledge transfer to peers Must be able to work... ...and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 1...Medical deviceWork experience placementLocal areaRemote workFlexible hours
$59.95k - $102.62k
...on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing. Validation Engineer / CQV Engineer Responsibilities: Change Control Management Author, review, and manage change controls...Medical deviceTemporary workWork experience placement$156k - $228.8k
...global healthcare leader headquartered in Indianapolis... ...The Delivery, Device, and Connected... ..., including medical devices, combination... ...partnership with M&Q for capabilities in... ...development and validation Tooling, fixturing... ...are scalable and transferable across internal sites...Medical deviceFull timeFlexible hours- ...work with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries - who all trust... ...environment Method Support • Support qualification and transfer of analytical test methods • Ensure assays are executed consistently...Medical deviceFull time
- A leading engineering company in the Indianapolis area seeks an experienced Project Manager for Commissioning & Qualification (C&Q). This role involves managing C&Q activities for pharmaceutical manufacturing projects, ensuring compliance with regulatory standards, and...
- ...FMEA, 5 Why, and risk analysis methods • Assist with method validations, equipment qualifications, and continuous improvement... ...field • 3+ years of experience in pharmaceutical, biotech, or medical device manufacturing environments • Strong understanding of quality...Medical deviceWork at office
$120.97k
...the Remedial Action Discipline Leader. This national leadership role... ...staff, facilitate knowledge transfer, and support professional growth... ..., childbirth and related medical conditions, sexual orientation... ...Requirements: An appropriate and valid driver's license is required....Full timeH1b$126k - $204.6k
...are a global healthcare leader headquartered in... ...Assurance Specialist - Device Complaints plays a critical... ...combines strong GMP and medical device fundamentals with... ...activities Mentor junior QA team members Continuous... ...of any promotion or transfer of Lilly employees. #WeAreLilly...Medical deviceFull timeWork visaFlexible hours- ...candidate holds a relevant engineering degree, has at least 5 years of experience in quality or metrology environments, and demonstrates strong communication skills. Join us to drive measurement excellence in medical device manufacturing. #J-18808-Ljbffr Kimball ElectronicsMedical device
- ...work with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries - who all trust... ...Method & Lab Support Assist with method qualification, transfer, and troubleshooting Help ensure consistency and quality of...Medical deviceFull time
$106k - $197k
...Candidates should possess a Bachelor's, Master's, or PhD in a related field, along with several years of relevant experience in IVDs/medical devices. A salary range of $106,000-$197,000 is anticipated, and additional benefits are detailed in the company catalog. #J-18808-...Medical device- ...About The Role Ambu is a global industry leader with the soul of a startup. Our... ...improve patient care through innovative medical devices and industry changing single use scopes... ...objections through clinical and financial validation, and Works with a tremendous sense of...Medical deviceWork experience placementLocal area
- ...identify process improvements and quality risks. Support method validation, equipment qualification, and protocol execution activities.... ...3+ years of experience within pharmaceutical, biologics, medical device, or regulated manufacturing environments. Experience supporting...Medical deviceWork at office
- Roche in Indianapolis is seeking a strategic leader to maximize the value delivery of Diagnostics. This role involves leading M&A integrations... ...should have 5-7 years of experience in diagnostics or medical device industries, along with strong influence and problem-solving...Medical deviceRemote work
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