Jobs in San Mateo County, CA
721 positions found — Page 26
QA Program Manager – GCP / GLP / GVP
We are partnered with a well established Medical Device company looking to expand their Quality Assurance team.
They are seeking an experienced QA Program Manager, this individual will support the embedded Quality leadership across clinical, nonclinical, and pharmacovigilance programs from early through late-stage development.
Key Responsibilities
- Lead and conduct GCP, GLP, and GVP audits
- Provide hands-on QA support across study planning, execution, and close-out
- Drive inspection readiness and support global regulatory inspections (FDA, EMA, ICH)
- Lead deviation investigations, root cause analyses, and CAPA implementation
- Oversee and qualify external vendors to ensure ongoing compliance
Profile
- 7+ years’ QA experience in pharma, biotech, or medical device
- Strong background supporting clinical, nonclinical, and PV activities
- Proven audit leadership and regulatory inspection support
- Experience in imaging agents, diagnostics, or combination products preferred
Seeking a west coast P&C Account Executive for a national private equity-M&A practice for a top 5 broker in the world.
The primary role of the Account Executive is responsibility for placement and client management on an assigned book of business, as well as guiding the Service team.
The AE is responsible for a more complex book of business, based on industry specialty, account revenue size and/or coverage complexity, such as loss sensitive programs, large deductibles, captives or shared and layered programs.
Overview
Whistler Partners is partnering with a nationally recognized technology and life sciences law firm seeking a mid-level associate (3+ years) to join its world-class Technology Transactions practice.
This team handles complex, cutting-edge technology transactions for some of the most prominent technology, digital media, and consumer tech companies in the United States and internationally — from early-stage innovators to publicly traded market leaders.
The practice works closely with one of the top-ranked startup, IPO, and M&A corporate platforms in the country, offering associates meaningful exposure to the intellectual property and commercial aspects of transformative deals.
Why this role?
At the Center of Innovation
You’ll advise emerging and established technology companies on mission-critical commercial agreements, licensing arrangements, and strategic transactions involving high-value IP and data assets.
True Deal Adjacency
This practice works hand-in-hand with corporate teams on M&A, IPOs, and other major transactions. You’ll counsel on the intellectual property and commercial components of deals — not just standalone contracts.
Breadth Across Growth Stages
From startup technology companies to public enterprises, you’ll gain exposure across the full company lifecycle.
Platform Strength + Optionality
This is a nationally recognized tech transactions group within a broader firm known for its dominance in startup and life sciences work — a powerful foundation whether your long-term goal is partnership or in-house leadership.
Key Responsibilities
- Draft and negotiate complex commercial and technology agreements
- Advise on software licensing, IP commercialization, SaaS, data rights, and platform agreements
- Support M&A and other corporate transactions on IP and commercial diligence and structuring
- Counsel clients on contract and intellectual property strategy
- Work closely with corporate teams advising startup, growth-stage, and public companies
Ideal Candidate Profile
- 3+ years of substantial law firm experience in technology transactions
- Strong grounding in intellectual property and contract law
- Experience handling complex commercial agreements for technology companies
- Exposure to IP and commercial aspects of M&A or other corporate transactions
- Superior academic credentials
- Excellent drafting, communication, and interpersonal skills
- Barred in the jurisdiction of application or eligible to waive/sit for the next exam
Locations
Boston, New York, Silicon Valley, San Francisco, or Santa Monica.
About Whistler Partners
Matchmakers, Not Headhunters
Whistler Partners is a boutique matchmaking firm focused on counseling the best and the brightest attorneys over the course of their careers. We believe that the right move comes from working closely with talent to curate their long-term career paths. When it comes to career advice, what matters is not the size of the agency but the strength of your individual recruiter.
We readily admit that we are elite and only work with the best – after all, a little elitism is okay when it comes to your career. Employers love us because we are picky about whom we represent, and attorneys love us because we get them their dream jobs.
We are seeking an experienced Monitoring Quality Oversight Manager to support multiple oncology clinical trials for one of our growing biotech client. This role provides strategic and hands-on oversight of CRO monitoring activities to ensure data integrity, regulatory compliance, and high-quality trial execution. The position partners closely with Clinical Operations, CROs, and Quality teams to identify risks, implement best practices, and drive continuous improvement across studies.
Key Responsibilities
- Perform monitoring quality oversight across multiple clinical studies
- Develop and execute monitoring oversight plans and risk mitigation strategies
- Review monitoring plans, reports, and trends; implement corrective actions as needed
- Provide subject matter expertise to internal teams and external partners
- Support SOP development, training initiatives, and inspection readiness
- Present oversight findings and recommendations to leadership
- Track monitoring metrics and follow up on CAPAs
- Bachelor’s degree in life sciences or related field
- 6+ years of biotech/pharma experience, including 3+ years in monitoring oversight
- Oncology clinical trial experience required
- Strong knowledge of GCP, ICH, and regulatory guidelines
- Proven CRO oversight and stakeholder management experience
- Excellent analytical, communication, and organizational skills
- Ability to work independently in a fast-paced, remote environment
- Willingness to travel up to 80%
Estimated Min Rate: $80.00
Estimated Max Rate: $100.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
Client: Medical Device
Details:
- 6-Month contract with high potential of conversion
- 40-Hours per week, on-site in SSF
Requirements:
- 6+ years of experience in the medical device industry with at least 3 years of experience in a management, supervisory or lead role
- Experience in building a production team and overseeing assembly team schedule
- Hands-on experience with assembly, testing, or packaging of electromechanical or disposable medical devices
Senior Manufacturing Process Engineer
Meet has partnered with an exciting Stealth start-up in the Brain-Computer Interface (BCI) space based in the San Francisco Bay area. The company is developing cutting-edge medical devices and technology for the treatment of unmet neurological disorders. The Head of Operations is seeking an experienced Manufacturing Process Engineer to support NPI of electro-mechanical devices in collaboration with suppliers.
This role will focus on hands-on interaction with suppliers to develop manufacturing processes, tooling, and documentation, from design feasability through commercial release. This role will require real-time engagement and technical support of suppliers, and this individual will be expected to travel often to domestic supplier sites and occasionally to international suppliers.
Primary Responsibilities:
- Serve as the primary technical liaison to external manufacturing partners, ensuring successful delivery of components, assemblies, and finished devices
- Collaborate with product development teams to ensure designs are manufacturable and compliant with medical device quality system requirements
- Develop and maintain manufacturing documentation, including work instructions, process flows, and validation protocols
- Support supplier implementation of specifications, manufacturing processes, and quality requirements
- Lead and participate in process validation activities including IQ/OQ/PQ, PFMEA, and failure investigations
- Drive continuous improvement initiatives related to manufacturing efficiency, quality, cost, and scalability
- Support resolution of non-conformances and corrective actions with suppliers
- Ensure manufacturing activities comply with applicable regulatory requirements (FDA, ISO 13485, EU MDR, etc.)
- Provide hands-on technical support to suppliers, including travel as needed (domestic and international)
Role Requirements:
- B.S. in relevant engineering discipline, or equivalent experience.
- 10 or more years of medical device manufacturing experience, preferably in senior roles at start-up companies developing and manufacturing electro-mechanical devices.
- Experience with active implantable systems (Implant, Leads, Externals, etc.).
- Experience with medical device manufacturing including molding, laser welding, clean room assembly, packaging, labeling, and sterilization.
- Experience with electronic manufacturing and test including PCB fab, PCA assembly, microelectronics assembly, flip chip, in circuit test (ICT) and functional test.
- Experience with manufacturing automation.
- Experience in defining and executing process validation activities.
- Experience collaborating with internal customers and external partners.
- Understanding of and experience implementing validating manufacturing processes for medical devices in accordance with FDA and EU Requirements.
- Experience with Solidworks, Labview / manufacturing process and test automation software.
- Ability to travel to Domestic and International supplier sites frequently
Our client is looking for an IP Litigation Associate with 3 to 5 years of AMLAW 200 experience for their very sophisticated practice group. The firm is looking for those that have backgrounds in Electrical Engineering or Computer Science from top schools for this above market to market salary opportunity in any of their 3 locations: Washington D.C., New York or San Francisco. This is a fantastic opportunity to work with a close-knit group that offers no billable hour requirements and the ability to work on some of the most important intellectual property disputes in recent times. If you or someone you know meet these requirements, please message me today. I would LOVE to chat!
Head of Operations and Manufacturing Ripple Medical | California (Hybrid or Remote) | Full-Time
ABOUT RIPPLE MEDICAL
Ripple Medical is a health tech company on a mission to revolutionize hypertension management with our cuffless blood pressure wearable. Once cleared by FDA, our product will enable patients to easily and accurately monitor blood pressure at home, empowering them and their providers with actionable data to improve outcomes. We're a collaborative, mission-driven team of 33 working in a medical device regulatory environment to bring this technology to the millions of patients who can benefit.
POSITION SUMMARY
The Head of Operations and Manufacturing will own the end-to-end operational infrastructure required to bring Ripple's FDA-regulated cuffless blood pressure monitor to market and scale production. This is a hands-on leadership role for someone who thrives building from zero to one in a regulated environment: selecting contract manufacturers, standing up supply chains compliant with FDA 21 CFR Part 820, establishing ISO 13485-certified quality management systems, and preparing for direct-to-patient fulfillment.
As a company preparing for 510(k) submission and commercial launch, this role is critical to ensuring we can reliably manufacture and deliver a high-quality, FDA-cleared medical device at scale. The ideal candidate brings deep experience in medical device manufacturing (particularly wearable or electro-optical devices), understands regulated hardware supply chains and design transfer, and can roll up their sleeves while building the team and processes for long-term growth.
This position reports directly to the CEO with high visibility to the leadership team and Board of Directors.
KEY RESPONSIBILITIES
Manufacturing & Production
- Lead selection and onboarding of contract manufacturing partners with Class II medical device experience, including RFQ, quality audits, contract negotiation, and ongoing management.
- Own design transfer and manufacturing transfer, working with engineering on DFM principles, Device Master Record (DMR) requirements, and production readiness.
- Establish production planning, forecasting, and capacity management for V&V builds, pilot production, and volume manufacturing.
- Drive continuous improvement in yield, quality, and cost while maintaining FDA and ISO compliance.
- Oversee pilot runs and scale-up, including process validation (IQ/OQ/PQ) and manufacturing controls.
Supply Chain & Procurement
- Build and manage the end-to-end supply chain, including component sourcing, supplier qualification, and inventory management per FDA purchasing controls.
- Develop supplier relationships and negotiate terms while ensuring supply continuity, traceability, and risk mitigation.
- Implement inventory planning to balance working capital with service levels, including buffer strategies for Year 1 launch.
- Monitor and mitigate supply chain risks: component shortages, single-source dependencies, geopolitical factors, and logistics disruptions.
Quality & Regulatory Compliance
- Maintain and improve the ISO 13485-certified QMS in partnership with the quality and regulatory team, ensuring FDA 21 CFR Part 820 compliance.
- Support 510(k) submission activities related to manufacturing, including process validation documentation, DMR development, and device history records (DHR).
- Define incoming inspection, in-process controls, and final product testing consistent with the risk management file.
- Manage product certifications for a Class II device, including FDA registration, UDI compliance, and applicable international requirements.
- Lead root cause analysis and CAPA for quality issues, ensuring post-market surveillance compliance.
Fulfillment & Logistics
- Design the direct-to-patient fulfillment strategy, including 3PL selection with FDA-cleared Class II device experience.
- Establish logistics and distribution for nationwide shipping of a regulated device with chain-of-custody and traceability.
- Develop returns, replacement, and warranty processes that balance patient experience, cost, and compliance.
Team & Organizational Development
- Start as an individual contributor who executes hands-on, then build and lead the operations team through 510(k) clearance and commercial launch.
- Establish operational metrics and dashboards for manufacturing, supply chain, and quality performance.
- Partner with finance on cost modeling, COGS optimization, and operational budgeting.
- Collaborate cross-functionally with engineering, software, regulatory, and commercial teams.
QUALIFICATIONS
- 7-12 years in manufacturing, operations, or supply chain, with 3-5+ years in medical devices (Class II preferred), wearables, or regulated hardware.
- Experience managing contract manufacturers for regulated medical devices, preferably in Asia and/or domestically.
- Experience at or with CMs/EMS providers (Flex, Jabil, Celestica, Plexus, Sanmina) in Class II medical device or wearable programs is a strong plus.
- Track record of design transfer and scaling production from pilot to volume for regulated products.
- ISO 13485 and FDA 21 CFR Part 820 experience required.
- Familiarity with the 510(k) process and manufacturing documentation (process validations, DMR/DHR) strongly preferred.
- Bachelor's in Engineering, Supply Chain, Operations, Biomedical Engineering, or related field; MBA or advanced degree a plus.
- Based in California or travel up to 25%.
COMPENSATION
- Base Salary: $160,000 - $210,000 USD
- Performance Bonus: Tied to company milestones and personal objectives
- Equity: Early-stage stock option grant with meaningful ownership
- 100% Employer-Paid Healthcare: Medical, dental, and vision
- Additional Benefits: 401(k) with company match, flexible PTO
Location: Remote
Length: 11 month contract
Compensation: $125-$145/hr
Job Summary
A clinical-stage precision oncology biotechnology company is seeking a Director, Biostatistics to lead statistical strategy and execution across its oncology development programs. The organization focuses on developing targeted therapies for molecularly defined solid tumors, with a pipeline spanning early- through late-phase clinical development.
The Director will serve as the statistical lead across cross-functional teams and play a key role in clinical development planning, study design, regulatory interactions, and submissions. This individual will oversee internal and external biostatistics resources, ensure high-quality and timely deliverables, and represent the biostatistics function internally and externally, including interactions with regulatory agencies and key opinion leaders.
Key Responsibilities
- Provide strategic statistical leadership for oncology clinical programs from Phase 1 through regulatory submission.
- Contribute to Clinical Development Plans, study protocols, and Statistical Analysis Plans (SAPs).
- Oversee design, analysis, and interpretation of clinical trial data, including interim analyses and Clinical Study Reports (CSRs).
- Establish and maintain statistical standards and methodologies across clinical, translational, and pharmacology datasets.
- Manage and mentor biostatistics staff, programmers, consultants, and vendors to ensure high-quality statistical outputs (TFLs, analyses, datasets).
- Review and approve key study documents including protocols, SAPs, CRFs, CSRs, and publications.
- Represent biostatistics in cross-functional discussions and regulatory interactions.
- Translate scientific questions into rigorous statistical approaches and clearly communicate results to diverse stakeholders.
- Ensure compliance with regulatory expectations and stay current with evolving statistical methodologies and industry standards.
- Ph.D. or M.S. in Statistics or related field.
- 12+ years of biostatistics experience in pharmaceutical drug development, including 8+ years in oncology.
- Extensive hands-on experience developing complex protocols and SAPs and performing analyses from early-phase through submission.
- Direct involvement in multiple NDA/BLA submissions with successful oncology approvals.
- Deep expertise in clinical trial design and advanced statistical methodologies, including time-to-event analyses.
- Proven leadership experience in cross-functional environments with strong communication and organizational skills.
Estimated Min Rate: $125.00
Estimated Max Rate: $145.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
About the Company
We are seeking an experienced Epic Cupid and Radiant Credentialed Trainer to design and deliver high-quality training for both inpatient and outpatient clinical teams.
About the Role
The ideal candidate will have 10+ years of hands-on Epic experience, proven classroom training ability (virtual and in-person), and a strong background in cardiology and radiology workflows. This role partners closely with Epic analysts and clinical stakeholders to develop role-based curricula, training materials, and competency assessments to support implementations, upgrades, and ongoing optimization.
Responsibilities
- Creating training plans
- Facilitating classes
- Conducting train-the-trainer sessions
- Documenting training outcomes
- Supporting go-live and post-go-live adoption efforts
Qualifications
- 10+ years of Epic Cupid and Radiant experience
- Proven classroom training experience—both virtual and in-person
- Experience working in an academic medical center (e.g., UCSF, UCLA, UCSD, UCDavis, or other university health systems) and training inpatient and outpatient clinical workflows
- Strong communication and collaboration skills; experience working with Epic analysts and clinical SMEs
- Ability to develop role-based curricula, job aids, and competency assessments
Required Skills
- Epic trainer/credentialed in Cupid and Radiant
- Experience in academic medical center environments or large health systems
- Prior experience supporting go-live and sustainment activities
How to Apply:
Straightforward, easy one-click apply.
EEO Statement:
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color,
creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and
related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and
veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic
information, or any other characteristic protected by applicable federal, state, or local laws and Ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental
coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully
vested after you become eligible, paid time off, sick time, and paid company
holidays.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors
considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge,
skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other
law.
