Recall & Field Action Lead — Hybrid Medical Devices
Connexion Systems and Engineering, Inc.
Connexion Systems & Engineering is seeking an experienced Senior Recall Specialist to join the Quality & Regulatory team supporting medical device products. The role focuses on leading field actions and recalls, ensuring FDA compliance and facilitating effective stakeholder communications. You will collaborate with Quality, Regulatory Affairs, Operations, R&D, Legal, Marketing, and Supply Chain to develop and execute recall strategies, prepare regulatory submissions, and monitor remediation #J-18808-Ljbffr Connexion Systems and Engineering, Inc.
$110k
Title: Senior Field Action & Recall Specialist Hiring Organization: Connexion... ...Kirkwood, DE Work Model: Hybrid (flexible) Schedule: Monday... ...Regulatory team supporting medical device products. This is an... ...valued. Key Responsibilities Lead the planning, coordination,...FieldMedical deviceFull timeMonday to FridayFlexible hours- ...spectrometric (LC-MS/MS, LC‑HRMS, hybrid/immunoaffinity mass spec),... ..., biotechnology and medical device companies with their drug development... ...for those new to the field. Our seasoned professionals are... ...Employment Opportunity/Affirmative Action Employer. In accordance with...FieldMedical devicePermanent employmentTemporary workFor contractorsTraineeshipH1bWork at officeLocal areaWorldwideVisa sponsorship
- ...spectrometric (MS/MS, MS/HRMS, hybrid/immunocapture mass spec)... ...pharmaceutical, biotechnology and medical device companies with their drug... ...especially for those new to the field. Our seasoned professionals... ...Employment Opportunity/Affirmative Action Employer. In accordance with...FieldMedical deviceTemporary workFor contractorsWork at officeLocal areaWorldwide
- Qnity is looking for a Sustainable Packaging Compliance Lead in Wilmington, DE, with a hybrid work arrangement. This critical role involves monitoring... ...Bachelor’s degree in Environmental Science or a related field, with over 8 years of experience in environmental compliance...Field
$118.02k - $180.31k
...nuclear fleet. Candidates should have at least ten years of experience in the nuclear field, strong communication skills, and the ability to manage critical projects. The position offers a hybrid work model, comprehensive benefits, and a competitive salary range from $118,023...Field- ...developing user-facing applications for medical devices related to breast and skeletal health. This... ...full time, we are open to discuss hybrid flexibility for the right candidate. At... ...Bachelor’s or Master’s Degree in a related field. Technical ExperienceBachelors Degree -...FieldMedical deviceFull timeLocal area
- ...control practices, corrective actions, continuous improvement... ...processes. Ensure compliance with Medical Device Regulations, cGMP, CFR 820, ISO... ...'s degree in an Engineering field from an accredited university... ...required. ISO 13485 Lead Auditor certification required...FieldMedical device
$167.4k - $297.6k
...is seeking a Director of Design Assurance located in Newark, DE (Hybrid). This role entails strategic leadership, managing the Design... ...background, with at least 12 years of relevant experience in the field. Responsibilities include overseeing product development activities...FieldMedical device- ...and reliability of life-saving medical devices? At Hologic, we are seeking a... .... In this role, you’ll lead complaint investigations, perform... ...implement corrective and preventive actions to improve product quality... ...a commitment to addressing field quality issues and ensuring...FieldMedical device
- ...spectrometric (LC-MS/(HR)MS, and hybrid/immunoaffinity mass spec)... ...pharmaceutical, biotechnology and medical device companies with their drug... ...Technology, or related field Strong troubleshooting skills... ...Employment Opportunity/Affirmative Action Employer. In accordance with...FieldMedical devicePermanent employmentTemporary workFor contractorsInternshipH1bWork at officeLocal areaWorldwideVisa sponsorship
- ...post-market data, customer feedback, and field investigations, and works... ...required for investigations and corrective actions or product/process improvements.· Design... ...Experience· At least 3 years experience, in a medical device process and/or product development environment...FieldMedical device
- ...electronics behind our industry‑leading imaging systems. In... ...support life‑saving medical technology used in... ...support of manufacturing and field service.Specify, select... ...effective corrective actions.Create and maintain... ...FDA‑regulated medical device or similarly regulated...FieldMedical device
$127k - $184k
...Advisor and Execution Lead, Checking and Deposits... ...translate strategy into action, establish disciplined... ...following hub locations with a hybrid schedule of four days... ...Management, or related field Advanced degree... ...comprehensive benefits including medical, dental, and vision...FieldLocal areaRemote workFlexible hours1 day per week- ...audits, risk management, and corrective actions. Knowledge Proficient understanding of U... ...1 CFR Parts 11 and 820), ISO 13485, and medical device quality systems Experience in root cause... ...Chain Management, Logistics, or a related field (advanced degree is a plus) Minimum of 3...FieldMedical deviceWork at office
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., especially for those new to the field. Our seasoned professionals are here to... ...Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state...FieldMedical devicePermanent employmentTemporary workFor contractorsWork at officeLocal areaWorldwide
- Hologic is a global medical technology company focused... ...producing life-saving medical devices.Job Summary:Product... ...teams, you will lead cross-functional efforts... ...corrective and preventive actions, ensuring continuous improvement... ....Partner with field-based teams to investigate...FieldMedical deviceLocal area
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., especially for those new to the field. Our seasoned professionals are here to... ...Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state...FieldMedical deviceTemporary workFor contractorsWork at officeLocal areaWorldwide
- ...CSDM/CMDB Ownership & Health: Lead CMDB design, governance, and ongoing... ..., alert noise reduction, and actionable insight delivery to operations... ..., or a related technical field (required).Master's degree or... ...solutions in complex, multi-cloud or hybrid environments.Proven track...FieldLocal areaRemote workWorldwide
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ...for corrective and preventative actions necessary to improve quality and compliance... ...opportunities, especially for those new to the field. Our seasoned professionals are here to...FieldMedical devicePermanent employmentTemporary workFor contractorsH1bWork at officeLocal areaWorldwideVisa sponsorship
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., especially for those new to the field. Our seasoned professionals are here to... ...Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state...FieldMedical deviceTemporary workFor contractorsLocal areaWorldwide
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., especially for those new to the field. Our seasoned professionals are here to... ...Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state...FieldMedical deviceTemporary workFor contractorsWork at officeLocal areaWorldwideShift work
- ...evaluates and monitors corrective actions, supports FDA inspections and... ..., Science, or related field. (Strongly recommended focus... ...CMDA (preferred), ISO 13485 Lead Auditor, EU MDR or EU IVDR Lead... ...- Clinical investigation of medical devices for human subjects - Good clinical...FieldMedical device
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., especially for those new to the field. Our seasoned professionals are here to... ...Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state...FieldMedical deviceTemporary workFor contractorsLocal areaImmediate startWorldwideShift work
- ...ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a... ....Analytical skills to support and lead investigations, including CAPAs, nonconformances... ...Engineering, or a related field. Risk Managers will also be considered.5...FieldMedical device
- ...automation systems, robotics, medical devices, and advanced industrial... ...manufacturing, vendors, and field service organizations. Participate... ...issues while driving corrective actions and continuous improvement... ...development and technical training Hybrid work environment with...FieldMedical deviceFull time
- ...Embedded Software Engineer to lead a team of engineers to design... ...embedded software for medical devices related to breast and skeletal... ...Implement and track solid corrective actions to reduce defects and... ...Master’s degree in a related field.Experience Preferred Minimum...FieldMedical deviceLocal area3 days per week
- ...seeking an IT PMO Manager in Wilmington, DE. This role requires a hybrid work schedule with on-site presence from Tuesday to Thursday.... ...management experience in IT and a Bachelor’s degree in a relevant field, along with strong leadership and communication skills. Benefits...Field
- ...is seeking a Sustainable Packaging Lead to monitor global packaging regulations... ...a Bachelor’s degree in a relevant field. The position offers a hybrid work model, with some international... ...process and translating regulations into actionable requirements. Join a motivated team...Field
- ...assisting pharmaceutical, biotechnology and medical device companies with their drug development... ..., especially for those new to the field. Our seasoned professionals are here to... ...Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state...FieldMedical devicePermanent employmentTemporary workFor contractorsH1bWork at officeLocal areaWorldwideVisa sponsorshipMonday to Friday
- ...improvement. The Specialist owns and leads the Post Market Surveillance... ...trends, signals, KPIs, and actions required for follow up... ...inputs for emerging issues, field escalations, and early investigations... ...or similar analytical role. Medical device experience preferred. Skills...FieldMedical deviceWork at office
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