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
| 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... | |||||
| Customer Service Representative - English & French-speaking | 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... | ||||||
| Quality Engineer I - Temporary | Hybridarbeit | Mittelstufe | 2024-34719.1 | Woodinville | Washington | United States | Woodinville, Washington, United States | Quality and Regulatory | The candidate will attend cross function Daily Management meetings and represent QA following up on blocking issues and implementing counter measures. The candidate will manage the Material Review Board and ensure thorough documentation of non-con... | ||||||
| Product Support Scientist | Hybridarbeit | (CHE_2003)DiaMed GmbH | Mittelstufe | 2025-35850 | Cressier | Fribourg | Switzerland | Cressier, Fribourg, Switzerland | Vertrieb/Marketing | Our company is involved in the supply of high-quality products and services intended for diagnostic laboratories. Independence, innovation and commitment are the fundamental values that permeate our company culture, as well as a strong orientation... | |||||
| Transportation Analyst (m/f/d) | Hybridarbeit | (DEU_2067)Bio-Rad Lab Logistik, Grosskugel | Mittelstufe | 2024-35526 | Kabelsketal | Sachsen-Anhalt | Germany | Kabelsketal, Sachsen-Anhalt, Germany | Supply Chain | The Transportation Analyst (m/f/d) will be responsible for optimizing transportation operations and analyzing transportation data to ensure cost-effective and efficient movement of goods. This role involves collaborating with cross-functional team... | |||||
| GSC Lean/Continuous Improvement Manager III | Essentiell (vor Ort) | (USA_1000)Bio-Rad Laboratories, Inc. | Senior-Level / Manager | 2024-35141.1 | Irvine | California | United States | Irvine, California, United States | Manufacturing / Produktion | As the GSC Lean/Continuous Improvement Manager III, you will drive business performance by using, promoting, and executing Lean Operational Excellence tools, processes, and concepts across. Utilizes Lean to determine what, why and measure how well... | |||||
| Maintenance Technician IV | Essentiell (vor Ort) | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2024-35381.1 | Richmond | California | United States | Richmond, California, United States | Manufacturing / Produktion | Bio-Rad is looking for a Maintenance Technician IV to support the manufacturing plant that produces process chromatography resins, liquid buffers, monomer solutions, oils, and other specialized life science products. In this role you will be part ... | |||||
| Treasury Analyst | Hybridarbeit | (HUN_2035)Bio-Rad Hungary Trading LLC | Mittelstufe | 2025-35843 | Budapest | Hungary | Budapest, Hungary | Finanz-und Rechnungswesen | We are looking for a hands-on, self-starter Treasury Analyst with multinational corporate experience to join our expanding and global Treasury function. The Treasury Analyst will report to the Assoc. Director International Treasury and will drive ... | ||||||
| Campaign Mgr | Hybridarbeit | (SGP_3001)Bio-Rad Laboratories - Commercial Singapore | Senior-Level / Manager | 2025-35769 | Singapore | Singapore | Singapore | Join the Life Science Outbound Marketing team as a Campaign Manager and play a key role in executing global campaigns within the Life Science Group. In this position, you'll be responsible for developing comprehensive campaign strategies, includin... | |||||||
| Software Business Analyst III | Hybridarbeit | (USA_1000)Bio-Rad Laboratories, Inc. | Mittelstufe | 2025-35775 | Hercules | California | United States | Hercules, California, United States | Forschung und Entwicklung | Bio-Rad Clinical Diagnostics Group (CDG) is one of the leading global providers of tests for infectious and autoimmune disease screening, diabetes screening and monitoring, blood grouping as well as a range of reagents and software for laboratory ... |
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."
