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Senior Quality Engineer

Santa Clara, CA, US • Posted 1 day ago • Updated 1 day ago

Full Time

No Travel Required

On-site

$120,000 - $140,000/yr

Stanley David and Associates

Fitment

Dice Job Match Score™

⏳ Almost there, hang tight...

Job Details

Skills

IQ
Medical Devices
ISO 13485
Issue Resolution
Regulatory Compliance

Summary

Must Have Technical/Functional Skills

• Strong understanding of Medical Device Quality Systems and regulatory compliance requirements

• Working knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation)

• Strong expertise in design transfer activities, including DHF → DMR transition and compliance with FDA 21 CFR 820 & ISO 13485

• Sound knowledge of Medical Device Regulations, including MDD and MDR

• Proven experience in Non Conformance (NC) management, CAPA processes, and internal/external audits

• Expertise in Medical Device Risk Management, with the ability to identify both apparent and less obvious risks

• Practical experience with Application, Process, Design, and System FMEA methodologies

• Proficient in statistical tools and techniques, including Design of Experiments (DOE)

• Capable of performing advanced descriptive and non parametric statistical analyses

• Experienced in leveraging advanced statistical methods for reliability prediction and data driven decision making

Roles & Responsibilities

• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.

• Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.

• Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework.

• Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).

• Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.

• Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements

• Collaborate with cross functional teams to deliver quality compliant outcomes

• Interpret and apply medical device regulations and standards to projects and processes

• Support audits and regulatory inspections, ensuring timely closure of actions

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91097129
Position Id: 9024915
Posted 1 day ago

Company Info

About Stanley David and Associates

We strive to add value and work as true partner with our clients

Stanley David And Associates is a recruitment specialist in the area of IT and Engineering and we stay firmly in our area of expertise, doing what we love.

We know the players and the companies and invest a lot of time getting to know candidates and clients in equal measure. This ensures a swift, cost effective and perfect placement whether it s permanent or interim.

In addition we have a reputation for having the best understanding of the market landscape, for sourcing great candidates

-We have a Global Footprint with offices in 3 countries USA, UK and India.

-SDNA Global have built up an incredible reputation within the IT strategic hiring.

-We work with Tier1 and Tier 2 IT Outsourcing companies for Leadership hiring needs in UK, Europe, USA and Indian geos.

-Each SDNA member has over 5 years of experience in Talent Acquisition

-We have successfully closed roles in countries UK, USA, Germany, Sweden, Dubai, France, Netherlands, Switzerland, Austria, Hungry, Spain, Italy, Norway, Denmark, Nigeria and South Africa

-Telecom, Media and Hi-tech

-Health care and Life Sciences

-Energy and Utilities

-CPG, Retail and Transport

-Banking and Financial Services

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Contact the job poster

Jane Austin

Recruiter! @ Stanley David and Associates

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