- Develop, implement, and maintain an effective QMS in compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
- Oversee the documentation and training programs related to the QMS, ensuring that all employees understand and adhere to quality procedures.
- Streamline Quality Systems and processes to support commercial growth.
- Commercial Complaint Processing with MDR/Vigilance experience is required.
- Responsible for the day-to-day management of the Quality Control activities.
- Responsible for assuring MRB control and timeliness.
- Provide support and establish alignment with Manufacturing and Operations.
- Implement metrics to identify commercial key improvements.
- Stay up to date with all relevant FDA and regulatory requirements and ensure that our product and processes remain compliant.
- Organize, review and prepare the Management Reviews. Represent Quality in management review.
- Oversee the complaint handling and corrective and preventive action (CAPA) processes to ensure timely resolution of issues and prevention of recurrence.
- Managing both internal and external audit, interface with regulatory body.
- Develop and execute the quality strategy to drive product quality and process efficiency improvements.
- Establish key performance indicators (KPIs) and quality metrics to monitor and report on the effectiveness of the QMS.
- Recruit, train, and manage a high-performing quality assurance team.
- Foster a culture of quality, teamwork, and continuous learning within the department.
- Collaborate with suppliers to ensure the quality of raw materials and components used in our products.
- Conduct supplier audits and assessments as needed.
- Management of the Supplier Corrective Action program.
- Lead risk management activities to identify, assess, and mitigate potential quality risks associated with our products.
- Develop a compliant new product development process with adherence to FDA Design control requirements and Risk Management ISO 14971 standards. Strong understanding and ability to apply risk benefit for commercial situations as needed.
- Collaborate closely with R&D, Manufacturing, Regulatory Affairs, Clinical, HR and other departments to integrate quality into all aspects of product development and manufacturing.
- Minimum of 10 years of progressive quality assurance experience in the medical device, electrosurgical industries (Class II, Class III, or PMA).
- Minimum 8+ years' experience as a manager; and 5+ years' experience in a senior managerial role.
- Strong knowledge of FDA regulations, ISO13485, and other relevant quality standards.
- Experience in medical device development, including development, manufacture and launch of Food and Drug Administration (FDA) reviewable medical products.
- Must have hands-on experience with supporting commercial medical device manufacturing and operations.
- Experience with Document Control and electronic QMS.
- Demonstrated management skills, including leadership, talent assessment, recruitment, retention, and development.
- Excellent communication and interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact. Ability to communicate technical information to non-technical audiences.
- Ability to work effectively and independently in a fast-paced, dynamic environment.
- Familiar with quality engineering, design and software verification and validation.
- Experience with identification of relevant compliance standards and associated testing.
- Bachelor's degree in related field; master's degree a plus.
- Stock Options
- 90% employer-paid medical, dental, and vision insurance
- Company-paid Basic Life Insurance
- 401(k) retirement plan (Traditional and Roth)
- Competitive Paid Time Off
- Paid Holidays
- FSA (Flexible Spending Accounts)
- HSA (Health Savings Account)
- Employee Assistance Program through PEO
- Pay range: $215,000 - $228,000 + Annual Bonus
-
Senior Quality Assurance
2 weeks ago
Revolution Medicines, Inc. Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic varian ...
-
Director, Quality Assurance
1 day ago
AdeptSource Redwood City, United StatesTitle: Director, Quality Assurance, Pharma Location: Redwood City, CA (hybrid model) Type of role: FTE, Full time Salary: plus bonus and equity Our start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal candidate ...
-
Manager, Quality Assurance
3 weeks ago
Natera San Carlos, United StatesPRIMARY RESPONSIBILITIES: Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions. · Maintain an influential and effective network and communication with leadership team members for identifying quality ...
-
Quality Assurance
3 weeks ago
Q Bio San Carlos, United StatesQuality Assurance & Regulatory Affairs Lead Q Bio is building technology for the Physical of the Future that measures more, faster and cheaper about the human body, to enable proactive primary care for all. We're revolutionizing primary care with the first clinical digital twin p ...
-
Quality Assurance Engineer
1 day ago
SLAC National Accelerator Laboratory Menlo Park, United StatesQuality Assurance Engineer · Job ID · 5940 · Location · SLAC - Menlo Park, CA · Full-Time · Regular · SLAC Job Postings · Position Overview: · The primary purpose of the Quality Assurance Engineer (QAE) position at SLAC is part of the Contractor Assurance and Contract Ma ...
-
Quality Assurance Engineer
2 weeks ago
SLAC National Accelerator Laboratory Menlo Park, United StatesQuality Assurance Engineer · Job ID · 5902 · Location · SLAC - Menlo Park, CA · Full-Time · Regular · SLAC Job Postings · Position Overview: · SLAC Contractor & Quality Assurance group is seeking a Quality Assurance Engineer (QAE). The primary purpose of the Quality Assu ...
-
Head of Quality Assurance
2 days ago
Oruka Tx Menlo Park, United StatesAbout Us: Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years ...
-
Quality Assurance Manager, Product Quality
2 weeks ago
Meta Inc Menlo Park, United StatesProduct quality organization at Meta is responsible for testing and assessing products' launch readiness to market from a correctness perspective. The team's charter is across Meta core products which we call the Family of Apps (e.g. Facebook, Instagram, Messenger, Threads, Ads p ...
-
Sr. Manager, Quality Assurance
2 days ago
BioSpace, Inc. San Carlos, United StatesJoin our Mission to Protect Humankind · Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to e ...
-
Director, Quality Assurance
2 weeks ago
Element Science Inc Redwood City, United StatesTHE COMPANY: · Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalizat ...
-
Director, Quality Assurance
2 weeks ago
AdeptSource Redwood City, United StatesTitle: Director, Quality Assurance, Pharma · Location: Redwood City, CA (hybrid model) · Type of role: FTE, Full time Salary: plus bonus and equity · Our start-up Biotech client is seeking an Associate Director / Director Quality Assurance to join their growing company. Ideal ...
-
Senior Quality Assurance
3 weeks ago
REVOLUTION Medicines Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic varian ...
-
Mgr, Quality Assurance
1 week ago
Natera San Carlos, United StatesPOSITION SUMMARY:Manager, Quality Assurance is responsible for supporting the quality management system, compliant with CAP, CLIA, NYS DoH, 21 CFR Part 820, and ISO This position tracks quality performance and makes decisions concerning quality issues by working directly with cro ...
-
Mgr, Quality Assurance
1 week ago
Natera San Carlos, United StatesPOSITION SUMMARY: · Manager, Quality Assurance is responsible for supporting the quality management system, compliant with CAP, CLIA, NYS DoH, 21 CFR Part 820, and ISO This position tracks quality performance and makes decisions concerning quality issues by working directly with ...
-
Quality Assurance Associate
1 week ago
Karius Redwood City, United States**About Karius** · - Karius is a venture-backed, life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challe ...
-
Mgr, Quality Assurance
4 days ago
Natera San Carlos, CA, United StatesPOSITION SUMMARY:Manager, Quality Assurance is responsible for supporting the quality management system, compliant with CAP, CLIA, NYS DoH, 21 CFR Part 820, and ISO This position tracks quality performance and makes decisions concerning quality issues by working directly with cro ...
-
Quality Assurance Analyst
3 weeks ago
Q Bio San Carlos, United StatesQ Bio is building technology for the · Physical of the Future · that measures more, faster and cheaper about the human body, to enable proactive primary care for all. We're revolutionizing primary care with the first clinical digital twin platform, powered by breakthrough whole ...
-
Staff Design Quality Assurance Engineer
2 days ago
Danaher Corporation Redwood City, United StatesDanaher Corporation · Staff Design Quality Assurance Engineer (Medical Device Software) · in · Redwood City , · California · Wondering what's within Beckman Coulter Diagnostics? Take a closer look. · At first glance, you'll see that for more than 80 years we've been dedicate ...
-
Quality Assurance
5 days ago
ATR International Milpitas, United StatesJob Description: · We are seeking a Quality Assurance (Inspector) for a very important clientPosition Summary:The Quality Assurance (Inspector) reports directly to the Quality Manager and is responsible for verifying compliance of in-process and finished assemblies with drawing ...
-
Associate Director, Clinical Quality Assurance
3 weeks ago
Third Rock Ventures Redwood City, United StatesRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic varian ...
Director, Quality Assurance - Redwood City, United States - Element Science
Description
SUMMARY OF ROLE
:We are seeking an experienced and dynamic Director of Quality Assurance to join our team. As the Director of Quality Assurance, you will play a pivotal role in ensuring the quality, safety, and compliance of our medical devices. You will lead a team of quality professionals and be responsible for implementing and maintaining a robust Quality Management System (QMS) to meet regulatory requirements and industry standards. The role will be managing Quality Control and the Quality Management System teams. Your leadership will drive a culture of continuous improvement and excellence in quality throughout our organization. This position reports to the Head of Quality Assurance.
RESPONSIBILITIES:
Quality Management System (QMS) Leadership:
Quality Operations:
Quality Compliance:
Audits, Compliant Handling and CAPA:
Quality Strategy and Continuous Improvement:
Team Leadership and Development:
Supplier Quality Management:
Quality Risk Management:
Cross-Functional Collaboration:
QUALIFICATIONS:
BENEFITS:
Element Science offers a very competitive salary and benefits package including, but not limited to:
The salary for this exempt-level position will be based on experience and qualifications within an established pay range.