Senior Requirements Coordinator and Quality Assurance Engineer
Senior Requirements Coordinator and Quality Assurance Engineer
Job Description:
We are seeking an experienced Software Requirements Coordinator with strong Business Analysis skills to join our team. A background in Quality Assurance is a plus. In this dual role, you will act as a key liaison between stakeholders, the development team, and QA, ensuring seamless communication and coordination. You will take the lead of the software requirements definitions, while proactively analyzing, reviewing, and refining product requirements for software applications used in clinical diagnostic instruments. Your work will ensure that our solutions meet the highest standards of quality, compliance, and functionality, critical for use in clinical environments.
Key Responsibilities
Business Analysis:
- Define, document, and manage software requirements based on stakeholder input and regulatory needs, maintaining clear alignment with project goals.
- Analyze and interpret complex business needs, translating them into detailed functional and technical specifications.
- Facilitate cross-functional collaboration, ensuring development and quality assurance are integrated with regulatory requirements and client expectations.
- Continuously refine processes to enhance requirement traceability and ensure robust software solutions that meet stakeholder and regulatory expectations.
Software Quality Assurance (Additional Scope):
- Manage bug tracking and oversee testing for compliance, usability, and performance for software interacting with diagnostic hardware.
- Work with cross-functional teams to troubleshoot and resolve issues, ensuring high-quality standards throughout the development lifecycle.
- Monitor and report on testing progress, and provide clear documentation of results, including defect tracking and resolution.
- Contribute to Development, execution, and documentation of comprehensive test plans and test cases to verify software functionality, performance, and compliance with industry standards and regulatory requirements.
Qualifications:
- Bachelor’s degree in a relevant field (e.g., Biomedical Engineering, Computer Science, Clinical Diagnostics).
- Proven experience (3+ years) in software product management and requirements definitions, ideally with medical or clinical diagnostic applications.
- Advantage: Experience in software Quality Assurance and relevant documentation (STP, STD etc.), ideally with medical or clinical diagnostic applications.
- Strong background in requirements gathering, analysis, and documentation.
- Excellent analytical skills, attention to detail, and experience with BA and SQA tools and methodologies.
- Proficiency in English; other languages are an advantage.
Preferred Skills
- Knowledge of software development methodologies (e.g., Agile, Scrum)
- Experience with requirement management tools and quality management systems (e.g. JIRA, Jama, Azure DevOps Test Plans, MTM).
- Prior work with medical devices or diagnostics companies.
- Knowledge of regulatory compliance in the medical field (FDA, ISO) and risk management processes.
- Certifications in or Business Analysis (CBAP) or Quality Assurance (ISTQB) are a plus.
Legal Entity: (ISR_2036)Bio-Rad Israel Ltd
Andere Personen angesehen
| Warehouse Associate I - Temporary | Essentiell (vor Ort) | Einstiegslevel | 2024-35627.1 | Fort Worth | Texas | United States | Fort Worth, Texas, United States | Helping with shipping and receiving. Assisting chemists with scrapping materials. Performing SAP transactions of incoming product. Assist in verifying goods received. Preparing documentation for shipping. Cleaning of lab spaces, warehouse fl... | |||||||
| Financial Analyst III | Hybridarbeit | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2025-35893 | Hercules | California | United States | Hercules, California, United States | Finanz-und Rechnungswesen | You will be a member of the Group Finance team as Project Financial Analyst supporting our R&D new products and business cases. You will support operational analysis for profitability and financial projects/programs as requested by Group managemen... | |||||
| Senior IT Auditor | Hybridarbeit | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2024-34718.4 | California | United States | California, United States | Finanz-und Rechnungswesen | Join Bio-Rad as a Senior IT Auditor! Are you passionate about IT auditing and eager to make a significant impact? Bio-Rad is looking for a dynamic Senior IT Auditor to join our team. In this role, you will be at the forefront of designing, planni... | ||||||
| Quality Control Tech I | Essentiell (vor Ort) | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2024-35465.1 | Santa Rosa | California | United States | Santa Rosa, California, United States | Quality and Regulatory | The Quality Control Technician will support the Quality Control department during the manufacture and release of Bio-Rad injection molded products. As a Quality Control Technician, you will be responsible for ensuring that all products meet the re... | |||||
| Engineering Technician II | Essentiell (vor Ort) | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2025-35848 | Richmond | California | United States | Richmond, California, United States | Ingenieurwesen | The Engineering Technician II is a vital team player for the Production Team at the Richmond Chemical Plant that manufactures chromatography resins, liquid buffers, monomer solutions, oils, and other specialized life science products. This role su... | |||||
| Quality Control Tech I | Essentiell (vor Ort) | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2024-35475.1 | Irvine | California | United States | Irvine, California, United States | Quality and Regulatory | In this role as a QC Technician, you will be responsible for the inspection and verification of critical parameters of all incoming purchased materials. This includes, but is not limited to, filters, chemicals, packaging materials, and OEM product... | |||||
| SAP GTS Analyst | Mobil | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2024-35095.1 | Texas | United States | Texas, United States | IT | We are seeking a skilled and experienced GTS SAP Analyst to join our team. In this role, you will work closely with cross-functional teams, including business analysts, developers, and other IT specialists on various IT projects where GTS could ha... | ||||||
| Account Mgr II | Feld | (FRA_2019)Bio-Rad France | Mittelstufe | 2025-35840 | MARNES-LA-COQUETTE | France | MARNES-LA-COQUETTE, France | Vertrieb/Marketing | Rattaché(e) à la Chef des Ventes Regional vous avez pour mission de vendre les produits et le savoir-faire du Groupe Bio-Rad et réaliser les objectifs commerciaux définis par la hiérarchie sur le secteur commercial attribué ou la gamme de produits... | ||||||
| Field Service Engineer Lombardia est (Milano, Bergamo, Brescia) | Feld | (ITA_2037)Bio-Rad Laboratories S.r.l. | Mittelstufe | 2025-35902 | Segrate | Milan | Italy | Segrate, Milan, Italy | Vertrieb/Marketing | As Field Service Engineer, you will be executing all service activities on the installed base technical equipment across customers, including but not exclusive to installation, maintenance, diagnosis, emergency repairs as planned by the local oper... | |||||
| French-speaking Customer Service Representative | Hybridarbeit | (HUN_2035)Bio-Rad Hungary Trading LLC | Mittelstufe | 2025-35856 | Budapest | Hungary | Budapest, Hungary | Vertrieb/Marketing | Customer Service Representative – Customer Relationship Management - English & French-language speaking Overview: In order to support Bio-Rad and our successful future growth we are seeking a highly motivated and experienced individual t... | ||||||
| Production/Chemical Dispensing Supervisor | Essentiell (vor Ort) | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2024-35164.1 | Irvine | California | United States | Irvine, California, United States | Manufacturing / Produktion | As the Production/Chemical Dispensing Supervisor, you will supervise the Lineside/Warehouse Department. This production team distributes chemical raw materials that are used to produce our liquid reagent products. You will plan and assign work t... | |||||
| Field Application Spec II | Feld | (IND_3006)Bio-Rad Laboratories (India) Pvt Ltd | Einstiegslevel | 2025-35838 | Mumbai | India | Mumbai, India | Vertrieb/Marketing | How You’ll Make an Impact: Provide pre-sales and post-sales onsite or online support to clients and professionally handle objections and questions. Troubleshooting of QC errors and guidance to customers. Assess customer’s requirements and edu... |
Jetzt bewerben
Danke
Treffen Sie einen Bio-Radian
Hören Sie mehr von einem Bio-Rad Mitarbeiter.
„Bio-Rad rocks! ...“
Wissenschaftler (aktueller Mitarbeiter) Plano, TX
"Bei der Fortführung der Mission "Advancing Science and Improving Lives" (Wissenschaft vorantreiben und Leben verbessern) haben Sie die Möglichkeit, Beiträge zu Produkten zu leisten, die das Leben auf dem Planeten Erde auf sinnvolle Weise verbessern. Ich schätze das Arbeitsumfeld in Plano und die Tatsache, dass ich Teil eines Teams bin, das seine Leistung zu jederzeit erbringt."
