- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
-
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 ...
-
Design Control Quality Engineer
3 weeks ago
Actalent San Mateo, United States Full timeDescription: · • Act as a quality engineer for medical device QMS quality improvement activities, with a focus on design controls and risk management. · • Provide oversight of quality improvement activities and ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ...
-
Quality Engineering Technician Iii
6 days ago
Pulmonx Corporation Redwood City, United States**Pulmonx** is looking for a **Quality Engineering Technician III** to join and our team Who is **Pulmonx**? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · **Resp ...
-
Quality Engineer
3 weeks ago
Verkada San Mateo, United StatesWho We AreVerkada is the largest cloud-based B2B physical security platform company in the world. Only Verkada offers six product lines - video security cameras, access control, environmental sensors, alarms, workplace and intercoms - integrated with a single cloud-based software ...
-
Quality Engineer
2 weeks ago
Verkada San Mateo, United StatesWho We Are · Verkada is the largest cloud-based B2B physical security platform company in the world. Only Verkada offers six product lines - video security cameras, access control, environmental sensors, alarms, workplace and intercoms - integrated with a single cloud-based soft ...
-
Quality Engineer
3 weeks ago
Joby Aviation San Carlos, United StatesJoby Overview: · Located in Northern California, the team at Joby Aviation is driven by our goal of creating an affordable, all-electric air transportation system. Imagine a piloted air taxi that takes off vertically, then quietly carries you and your fellow passengers over the ...
-
Quality Engineer
6 days ago
Joby Aviation San Carlos, United StatesJoby Overview Located in Northern California, the team at Joby Aviation is driven by our goal of creating an affordable, all-electric air transportation system. Imagine a piloted air taxi that takes off vertically, then quietly carries you and your fellow passengers over the cong ...
-
Quality Engineer
3 weeks ago
Cloud Analytics Technologies LLC San Carlos, United StatesWork Authorization: · US Citizen, Green Card, H-1B, GC-EAD, OPT-EAD, L2-EAD, TN Visa · US citizens (USC) and Permanent Residents (GC) are encouraged to apply. We are unable to offer any sort of Visa sponsorship for this position. · Local Candidates Preferred. Non-local candidate ...
-
Design Quality Engineer
3 weeks ago
Zoox Foster City, United StatesZoox is building a quality team that will take our first-in-class autonomous robot from development to commercialization. Design Quality Engineers will report to the Product Quality Manager and will support the Zoox Quality and Reliability organization through the development of ...
-
Supplier Quality Engineer
3 weeks ago
Zoox Foster City, United StatesFoster City, CA · • Full-time · Supplier Quality Engineer (Drive Module) · The Supplier Quality Engineer will play a key role in ensuring world-class performance of the Zoox prototype and production supply base, and drive continuous improvement. The ideal candidate will be entr ...
-
Image Quality Engineer
3 weeks ago
Zoox Foster City, United StatesZoox is looking for an Image Quality Engineer to support tuning and testing of our production cameras' automotive image sensors for autonomous vehicles. The Image Quality Engineer should be able to analyze image data from opto-electrical systems using standard software tools (e.g ...
-
Supplier Quality Engineer
4 weeks ago
Lorven Technologies Foster City, United StatesJob Title: Supplier Quality Engineer - Sensors · Location: Foster City, CA - Onsite · Duration: 6 Months Contract As a Supplier Quality Engineer - Sensors: Assess the capability of potential suppliers. · Assess the manufacturability of new product designs and assist the engineer ...
-
Sr. Quality Engineer
4 weeks ago
Gilead Sciences Foster City, United States RegularJob Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therap ...
-
Quality Engineering Manager
4 days ago
Penumbra Alameda, United States**What You'll Work On**: · - As a leader, manage the quality engineering functions in support of production to ensure conformance to the Penumbra Quality Management System, FDA QSR, ISO standards, and other regulatory requirements within a multidisciplinary team · - Direct manage ...
-
Quality Engineer III
1 week ago
Walmart San Mateo, United StatesPosition Summary...What you'll do... Contribute to an engineering team responsible for the backend service which supports the Walmart Omni Promotions Platform. Deliver manual and automated testing efforts for product features which advance the business and customer experience, al ...
-
Senior Quality Engineer
3 weeks ago
GILEAD Sciences San Mateo, CA, United StatesFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working rele ...
-
Supplier Quality Engineer
2 weeks ago
ICONMA San Mateo, United StatesLocation: Foster City, CA · Duration: 6 months · Responsibility · The Supplier Quality Engineer will play a key role in ensuring world-class performance of the Client prototype and production supply base, and drive continuous improvement. · The ideal candidate will be entrepr ...
-
Supplier Quality Engineer
3 weeks ago
Zoox San Mateo, United StatesThe Supplier Quality Engineer will play a key role in ensuring the world-class performance of the Zoox prototype and production supply base and driving continuous improvement. The ideal candidate will be entrepreneurial, driven, energetic, detailed, and team-oriented.In this role ...
-
Supplier Quality Engineer
3 weeks ago
ICONMA San Mateo, United StatesLocation: Foster City, CADuration: 6 monthsResponsibilityThe Supplier Quality Engineer will play a key role in ensuring world-class performance of the Client prototype and production supply base, and drive continuous improvement.The ideal candidate will be entrepreneurial, driven ...
-
Supplier Quality Engineer
3 weeks ago
Zoox San Mateo, United StatesFoster City, CAProcurement & Strategic Partnerships – Supplier Quality /Full-time/ HybridThe Supplier Quality Engineer will play a key role in ensuring world-class performance of the Zoox prototype and production supply base, and drive continuous improvement. · Below covers ever ...
Sr. Quality Engineer - Foster City, United States - Gilead Sciences
Description
Sr. Quality Engineer - Combination Products, Tech Transfer and Commercial page is loadedSr. Quality Engineer - Combination Products, Tech Transfer and Commercial
Bewerben
locations
United States - California - Foster City
time type
Full time
posted on
Vor mehr als 30 Tagen ausgeschrieben
job requisition id
R
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.
At Gilead, we're creating a healthier world for all people.
For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead.We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.
We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.Job Description
Sr. Quality Engineer - Combination Products, Tech Transfer and Commercial
This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as vial kits and pre-filled syringes, to market.
You will be a key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team on Design Transfer.
We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products.Roles/Responsibilities:
Provide Quality oversight for the Commercial stage, including Design Transfer
Create/revise/execute
SOPs to support combination product quality governance in the commercial stage.
Evaluate design changes and provide quality input to support continuous improvement initiatives.
Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards.
Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards. Work cross-functionally with Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively.
Create and provide Quality training as needed for cross functional stake holders and CMOs.
Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve complex technical related drug device combination product, process and quality issues.
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, WIs, etc.) as needed.
Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
Work with management and department personnel to achieve goals and strategic initiatives.
Supports due diligence and internal or external audits/inspections as needed.
Participate in annual product reviews and perform periodic review and update of DHF and RMF.
Support complaints investigations and filter information back to the design and development team and CMOs.
Knowledge, Experience & Skills:
Must have 6+ years of relevant experience and a Bachelor's degree in a Science or Engineering related field; or 4+ years of relevant experience with a Master's degree in a Science or Engineering related field
Medical device experience preferred
Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards.
Previous experience with combination devices is preferred (i.e., Autoinjectors, co-packaged kits, pre-filled syringes).
Quality experience in both clinical and commercial products.
Strong project management and process improvement skills.
Demonstrates understanding of U.S. and international quality systems
regulations/standards
to adopt best in class systems/processes and drive continuous improvement initiatives.
Knowledge of Six Sigma,
Define-Measure-Analyze-Improve-Control
(DMAIC) methodology, performance measures and quality improvement statistical is preferred.
Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis / or Failure Mode Effects Analysis (FMEA)) is preferred.
Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.
The salary range for this position is: $133, $172, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit:
United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or
mental
disability, genetic
information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
for assistance.
For more information about equal employment opportunity protections, please view the
'Know Your Rights'
poster.
NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.
Ähnliche Stellen (5)
Associate Director, Quality Engineering - Combination Products, Tech Transfer and Commercial
locations
United States - California - Foster City
time type
Full time
posted on
Vor mehr als 30 Tagen ausgeschrieben
Sr. Manager Quality – Combination Products, Compliance
locations
United States - California - Foster City
time type
Full time
posted on
Vor mehr als 30 Tagen ausgeschrieben
Senior Quality Engineer – Combination Product Development
locations
United States - California - Foster City
time type
Full time
posted on
Vor mehr als 30 Tagen ausgeschrieben
About Us
Gilead Sciences, Inc.
is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.#J-18808-Ljbffr