- Maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable Quality Modules, and requirements defined in local procedures.
- Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
- Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
- Review CSV Validation activities including deliverables from regulatory compliance standpoint.
- Provide support to external and internal audits related to computerized system validation activities.
- Advice a cross functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations, and accomplishing goals throughout timelines.
- Help, establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
- Partnering with internal and external teams; sharing information to increase the collective understanding of QA and Compliance programs.
- Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
- Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external).
- Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.
- Authoring and /or revising SOPs.
- Ability to provide guidance on revising validation documents and protocols.
- Administer applicable electronic systems.
- Assist as needed in audits and inspections.
- Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.
- Contribute to projects related to CSV improvements.
- Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
- At least 6-8 years' experience in the Medical Device / FDA regulated industry with 3-5 years' experience in either Quality Assurance, Quality Management, IT Compliance or equivalent.
- Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science or technical field.
- Excellent communication and negotiation (written, verbal, and presentation) skills, and advanced problem-solving orientation and decision-making skills.
- Demonstrate proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable authorities and/or industry groups.
- Thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications.
- Good knowledge of regulatory requirements (FDA, EMEA, ICH).
- Experience in international and multidisciplinary environments.
- Operational knowledge and experience with CS applications in a GXP environment.
- Experience in CSV auditing and inspections against regulatory and benchmark quality standards.
- Experience in working validation of ERP (SAP) and COTS application.
- Ability to evaluate risks, define and execute action plans and propose innovative solutions to solve problems.
- Ability to work on multiple projects concurrently and prioritize resources.
- Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization.
- Strong interpersonal and leadership skills.
- Proven ability to develop, present and justify positions to all levels within the company.
- Demonstrates attention to detail and organizational skills.
- Results driven with a strong customer and quality focus.
- Working experience on SaaS System Validation is desirable/preferred.
-
Liebherr Group Mountain View, United StatesDevelopment Quality Engineer Electronic im Bereich Qualitätsmanagement (m/w/d) Lindenberg · Faszinierendes schaffen: Ihre Aufgaben · Umsetzung der Qualitätsmanagementplanung in Entwicklungsprojekten · Planung und Durchführung von internen und externen Audits · Sicherung der Ent ...
-
Quality Engineer
3 weeks ago
Northrop Grumman Sunnyvale, United StatesAt Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be at the forefront of many technological advanc ...
-
Quality Engineer
3 weeks ago
Bayside Solutions Sunnyvale, United StatesQuality Engineer · W2 Contract · Salary Range: $135,200 - $156,000 per year · Location: Sunnyvale, CA - Hybrid Role · Requirements and Qualifications: · 10 years of programming experience in QA Automation, both developing test plans and automation · Proficiency in Python, J ...
-
Quality Engineer
1 week ago
Cerebras Sunnyvale, United StatesCerebras has developed a radically new chip and system to dramatically accelerate deep learning applications. Our system runs training and inference workloads orders of magnitude faster than contemporary machines, fundamentally changing the way ML researchers work and pursue AI i ...
-
Quality Engineer
1 week ago
JBL Resources Sunnyvale, United StatesOur Client, the pioneer of and global technology leader in robotic-assisted surgery has an opening for a Quality Engineer in Sunnyvale, CA. With a commitment to improving healthcare, our Client stands at the forefront, building leading-edge, integrated systems and software to pro ...
-
Quality Engineer
2 days ago
ZephyrTech Day Valley, United StatesAbout us At Day Valley, we focus on the future. Our intelligent sensors and embedded motor controllers for automotive and industrial electronics set new standards worldwide. Our home is in Freiburg im Breisgau, where a dynamic team of around 1,000 employees is waiting for you. Ou ...
-
Quality Engineer
2 weeks ago
Teledyne Microwave Solutions (TMS) Mountain View, United StatesTeledyne Microwave Solutions has over 50 years of experience in the design, development, and manufacture of sophisticated microwave/RF components and integrated assemblies for the most demanding challenges. Our products and capabilities are sought after by civilian and military o ...
-
Quality Engineer
3 weeks ago
Teledyne Mec Mountain View, United StatesTeledyne Microwave Solutions has over 50 years of experience in the design, development, and manufacture of sophisticated microwave/RF components and integrated assemblies for the most demanding challenges. Our products and capabilities are sought after by civilian and military o ...
-
Quality Engineer
3 weeks ago
Teledyne Mountain View, United StatesBe visionary · Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, e ...
-
Quality Engineer
1 week ago
Teledyne FLIR LLC Mountain View, United StatesBe visionary · Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, ...
-
Quality Engineer
4 days ago
Teledyne Mec Mountain View, United StatesTeledyne Microwave Solutions has over 50 years of experience in the design, development, and manufacture of sophisticated microwave/RF components and integrated assemblies for the most demanding challenges. Our products and capabilities are sought after by civilian and military o ...
-
Quality Engineer
3 weeks ago
FLIR Systems Mountain View, United StatesTeledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics desi ...
-
Quality Engineer
3 weeks ago
Teledyne FLIR LLC Mountain View, United StatesBe visionary · Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, ...
-
Quality Engineer
2 weeks ago
Teledyne Mec Mountain View, United StatesTeledyne Microwave Solutions has over 50 years of experience in the design, development, and manufacture of sophisticated microwave/RF components and integrated assemblies for the most demanding challenges. Our products and capabilities are sought after by civilian and military o ...
-
Sr. Quality Engineering Manager, Quality
3 weeks ago
Amazon Sunnyvale, United StatesAmazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of , Inc., originally creating the best-selling Kindle family of products. Since then, we have produced groundbreaking ...
-
Quality Engineering Technician
1 week ago
Joby Aviation San Carlos, United StatesJoby Overview: Located in Northern California, the Joby Aviation team is steadily working toward our goal of creating an affordable, all-electric air transportation system. Imagine an air taxi that takes off vertically, then quietly and quickly carries you over the traffic conges ...
-
Manager Quality Engineering
3 days ago
Intuitive Sunnyvale, United StatesCompany Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leader ...
-
Manager Quality Engineering
3 weeks ago
Intuitive Surgical Sunnyvale, United StatesCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in ro ...
-
Manager Quality Engineering
1 week ago
Intuitive Sunnyvale, United StatesCompany Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leade ...
-
Program Quality Engineer
3 weeks ago
Northrop Grumman Sunnyvale, United StatesProgram Quality Engineer /Principal Program Quality Engineer · Requisition ID: · R · Location: · Sunnyvale, California, United States of America · Clearance Type: · Secret · Telecommute: · No- Teleworking not available for this position · Shift: · 1st Shift (United States ...
Senior Software Validation Quality Engineer - Sunnyvale, United States - Intuitive
Description
Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position
Individual in this position will report into Senior Manager – Product Quality Digital & CSA. The primary responsibility of this individual is to represent PQ as an independent quality oversight on the GxP Computerized Systems Validation efforts globally across Intuitive sites around the world.
Essential Job Duties
Qualifications
Required Skills and Experience
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
&v=024){kind=logo}
Senior Software Validation Quality Engineer professionals in Sunnyvale
-
Sandeep Pal
Firmware Engineer | Embedded Software Developer
-
Vitalii Mariushkin
Sr. Test Engineer