Product Quality Engineer II: Medical Devices, CAPA & RCA
Hologic, Inc.
Hologic, Inc. is seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. You will lead complaint investigations, perform root cause analyses, and implement CAPA to improve product quality and compliance. Collaborating with Operations, R&D, and Engineering, you will drive process improvements, assess risks, and deliver solutions that enhance patient safety and customer satisfaction. A strong background in quality engineering is essential. #J-18808-Ljbffr Hologic, Inc.
$110k - $140k
Hologic is seeking a CAPA Facilitator, Engineer to lead robust Corrective and Preventive Action... ...and preventive actions for medical devices and diagnostic products. You will ensure CAPA records meet... ...engineering, manufacturing, quality, and regulatory teams, you will...Suggested- Hologic, Inc. is seeking a Product Quality Engineer to provide post-market quality engineering support for medical devices. You will own investigations, root cause analysis, risk assessment, and CAPA coordination with cross-functional teams to drive improvements based...Suggested
- Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment... ...functional team and communicate root cause, determine if CAPA is required, recommended changes and scope effort...Suggested
- Hologic is a global medical technology company focused on women’s health and wellbeing... ...producing life-saving medical devices.Job Summary:Product Quality Engineer will make a direct impact on... ...corrective and preventive actions (CAPAs) and implement product or process improvements...SuggestedLocal area
- Are you passionate about ensuring the quality and reliability of life‑saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on... ..., root cause analyses, and CAPA activities to resolve quality issues....Suggested
$120k - $150k
Hologic is seeking a Product Quality Engineer 3 to ensure the safety, reliability, and performance of... ...will drive root cause investigations, CAPA, and nonconformance resolution for manufacturing... ...learning, exposure to cutting-edge medical technologies, and global career growth...Worldwide- Hologic is seeking a Quality Engineer, CAPA Facilitator to support and strengthen Corrective and... ...regulated environment, particularly medical device, IVD, or pharmaceutical, and has demonstrated... ...with Agile or an equivalent Product Lifecycle Management system is beneficial...
- ...are seeking a Senior Software Engineer (C#/ .NET, Full Stack) to... ...software for new and existing products.The person in this role will... ...-facing applications for medical devices related to breast and skeletal... ...them.Design and develop high quality software. Develop and...Work at officeLocal areaWork from homeFlexible hours1 day per week
- ...support to the Supplier Quality organization... ...Define and approve PPAP (Production Part Approval Process... ...Surveillance, Quality Engineering, Manufacturing Engineering... ...compliance with Medical Device Regulations, cGMP, CFR... ...efforts (IQ, OQ, PQ), CAPA investigations,...
- ...integrated knowledge of assigned products to support medical device quality, compliance, and safety throughout... ...internal and external audits, NCEs, CAPAs, SSEs, QPLs, complaint... ...ExperienceBachelor's Degree, preferably in Engineering, Biomedical, or a related fieldMaster...
- ...12The Principal Post Market Quality Engineer serves as the senior technical... ...& Skeletal Health Solutions product lines to ensure patient... ...handling, complaint investigation, medical device reporting, reportability,... ...with design, manufacturing, CAPA, nonconformance, field...
- Hologic, Inc. in Newark, DE is seeking a Quality Inspector to perform incoming inspections for a medical device manufacturing environment. You will interpret drawings and GD&T, verify documentation, and record results in GDP-compliant records. You will use calipers, micrometers...
- ...Responsibilities: Test, calibrates and repairs production machines and related subassemblies to... .... Responsible for meeting or exceeding quality and efficiency standards. Ensures... ...Manufacturing environments is preferred; Medical Device experience is a plus.Role is...Shift workDay shift
$105k - $135k
...condensed benefits section:Senior Mechanical Engineer - Medical DevicesLocation: Wilmington, MASalary... ...-HavesExperience: 5+ years of medical device product development and mechanical design.... ...and formal verification testing.DHF & Quality: Lead Design History File...Flexible hours$45 per hour
...Wallace Montgomery is seeking a Highways/Roadway engineer , with at least 5 years of professional experience, to work in our Newark... ...engineers, and collaborate with cross-functional teams to deliver high-quality solutions. Primary Functions: # Prepare engineering...Hourly payFull timeContract workWork at office- ...passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development, ensuring that design controls, risk management, and global...
$130k - $150k
Quality Engineering Manager FREMONT AREA, CA — 100% onsiteSalary Range:$130,000-$150,000Employment Type: Full-timeKey Requirements:Minimum 8 years... ...resolution.Strong expertise in root cause analysis, 8D, CAPA, and corrective action programsExperience supporting SMT, Through...$75k - $100k
...Overview: New Ecology, Inc. is seeking an engineering candidate with 3-5 years of experience... ...analysis of upgrades; Conducting quality control inspections of completed... ...growth. Benefits: 403(b) with match, medical, dental, and vision coverage, 100% employer...Full timeFor contractorsWork at officeLocal areaRemote workWork from homeNight shiftAfternoon shift2 days per week- ...patient safety in the medical device industry? At Hologic,... ...regulatory compliance and quality assurance, this is... ...related to Hologic’s product portfolio.Familiarity... ...investigations, including CAPAs, nonconformances, and... ..., Nursing, Biomedical Engineering, Electromedical Engineering...
- ...essential in everyday technology devices from smartphones to electric... ...DuPont.The Mechanical Design Engineer develops and integrates... ...commercial off-the-shelf systems into production. Key ResponsibilitiesDesign... ...projects while meeting quality, cost, and timeline objectives...
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., Early Phase Clinical and Phase II – IV Clinical Research services. To meet... ...mission of improving human health and the quality of life. Team members enjoy challenging...Temporary workFor contractorsWork at officeLocal areaWorldwide
- ...a Senior Electrical Engineer, NPD to help design and... ...support life‑saving medical technology used in breast... ...for medical imaging products.Own portions of the... ...(cost reduction, quality, EOL, CAPA, VIP).What We’re Looking... ...FDA‑regulated medical device or similarly...
- Job Title Radar Digital Signal Processing Engineer Location Newark, DE About Us We are a premier provider of devices and components for microwave and millimeter-wave systems... ...phased array antennas for Tx and Rx.In our product portfolio are high-speed, high-power...Full timeRelocationFlexible hours
- ...inclusive meaningful career in power, distribution, transmission, engineering, design, technology, or innovation at Mesa Associates, Inc.... ...in site visits. Responsibilities: Serve as a Quality champion for Mesa and the design team and be part of Mesa’s Continuous...
- ...HVAC Mechanical Design Engineer My client is an excellent MEP Consulting Engineering firm who is actively looking for a Senior HVAC Mechanical Engineer or Designer who can oversee HVAC Mechanical Design projects and commit to a deadline driven schedule. Key is MEP...Immediate startRemote work
$80k - $100k
Mechanical Engineer II - Robotic Systems & AutomationLocation: Wilmington, MA (Hybrid: 2 to... ...Direct Impact: Take ownership of end-to-end product development, from rapid prototyping to... ...Insurance: 80 percent employer-covered medical premiums, plus comprehensive dental and...Work at officeLocal areaFlexible hours2 days per week- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., Early Phase Clinical and Phase II – IV Clinical Research services. To meet... ...mission of improving human health and the quality of life. Team members enjoy challenging...Temporary workFor contractorsLocal areaImmediate startWorldwideShift work
- ...exciting and challenging opportunity for a Raw Material Quality and Supplier Management (RQSM) Engineer job in Electronic Materials / Chemical Mechanical... ...process control parameters for raw material production in concert with internal and external stakeholders...
$127.9k - $184.1k
...challenges of the 21st century.We are looking for a Principal Quality Engineer to join our team in one of today’s most exciting technologies... ...best practices in areas such as risk-based thinking, new product qualification and validation, product and process control, root...Full timeWork at officeWorldwide- Job-ID32528399Reference26-01124Remote50% Remote Job Description: We are looking for a QA Engineer with Life Sciences domain experience to support testing and validation in a regulated environment. Responsibilities: Develop & execute manual and automation test cases....Remote work
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