Back to Jobs

Senior Quality Engineer

THINK Surgical
Fremont, CA
Job Summary

The Senior Quality Engineer is responsible for the quality, safety, and reliability of THINK Surgical products. This role requires expertise in supplier, design, manufacturing, and software quality engineering. The engineer must demonstrate an understanding of consumables and sterilization processes. The Senior Quality Engineer must have deep understanding and ability to effectively and efficiently apply the applicable requirements such as the Quality System Regulation (21 CFR 820) and ISO 13485. They must have a passion to spearhead and lead the effort to develop, maintain, and continuously improve our standard practices while proactively providing cross-functional support. This individual will act as the Quality representative on current and/or new product development, taking initiative to influence, coach, and mentor teams appropriately. An ideal candidate will have a high level of technical skillsets and depth of knowledge to support the development of complex medical robotics. Other responsibilities include supporting products throughout all development phases, test protocol development, process qualification/validation activities, the creation of statistically sound sampling plans, product investigations, and other quality processes. This position is based in the Fremont, CA Office.

Duties & Responsibilities

  • Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
  • Provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities.
  • Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Work with product development teams to develop measurable goals for quality.
  • Participate in the risk management process ensuring, when applicable, that hazards are adequately mitigated in product and process quality plans in accordance with THINK procedures and external standards (e.g. EN 14971).
  • Participate in Usability Engineering and planning documentation (e.g. EN 62366/ISO 62366,).
  • Contribute in software documentation according to IEC62304, biocompatibility testing according to applicable regulations and standards including ISO10993, and EMC testing according to IEC60601-1.
  • Interface with the other project team members and support the development effort for both product and packaging designs.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to THINK Surgical products.
  • Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report.
  • Plan and direct creation of quality standards, quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at THINK Surgical.
  • Ensure process compliance through the design and development of quality plans, procedures including work instructions, flowcharts, forms, templates, checklist and other product or process related documentation, for recording, evaluating, and reporting quality data.
  • Support new product introduction projects through development and execution of process validation and verification test plans, protocols and reports.
  • Perform DHF/DHR/DMR reviews for product release.
  • Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
  • Perform technical failure analysis based on the physics of failure.
  • Mentor and guide junior engineers and other QA team members, fostering knowledge development in quality engineering practices.
  • Assist the Quality Department on an as-needed basis.

Supervisory Responsibilities

  • N/A

Qualifications

Required:

  • Bachelor’s degree (or equivalent experience) with 7 plus years of related experience.
  • Ability to manage priorities and workflow in a rapidly changing environment.
  • Proven experience in design for reliability, manufacturability, and serviceability.
  • Proven experience managing quality in supplier, design, manufacturing, and software engineering environments.
  • Demonstrated knowledge of consumables, sterilization processes, and associated regulatory requirements.
  • Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
  • Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, and production process control methodologies in a medical device environment.
  • Previous work experience with product design changes, process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment.
  • Excellent organizational, problem-solving, and analytical skills.
  • Excellent verbal and written communication skills.
  • Excellent interpersonal and communication skills with the ability to develop trust, respect and confidence with internal and external customers.
  • Proficient technical writing skills, computer skills, and use of documentation programs such as Microsoft Office, Excel, Access, PowerPoint.
  • Experience in supporting quality audits and FDA inspections.
  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Preferred

  • Certified Quality Engineer.
  • Certified ISO 13485 Lead Auditor.
  • Experience with medical device hardware, electrical, and software development.
  • Strong background in process validation, risk management, and quality assurance for sterile devices and disposables.
  • Experience with sterile medical instrumentation and disposables in a regulatory environment.
  • Strong knowledge of fundamental quality and statistical tools.

COMPETENCIES

  • Drives results
  • Optimizes work processes
  • Decision Quality

PHYSICAL DEMANDS & WORK ENVIRONMENT

  • Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
  • Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
  • Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
  • Occasionally work around moving mechanical parts.
  • Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
  • Must be able to travel as business necessitates (up to10%).

Disclaimer

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.

THINK Surgical, Inc. (“THINK”) is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with their employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee’s eligibility to work in the United States. Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.
Posted 2025-11-21

Recommended Jobs

Electrical Test Engineer

Amca
El Segundo, CA

Electrical Test Engineer The Advanced Manufacturing Company of America (“Amca”) is a legacy business, built for the future. We’re putting engineers back in charge of aerospace and defense and rapi…

View Details
Posted 2025-11-19

Senior Staff Frontend Engineer

Coupang
Mountain View, CA

Senior Staff Frontend Engineer Location Mountain View, CA : We exist to wow our customers. We know we're doing the right thing when we hear our customers say, "How did we ever live without Coupang?" …

View Details
Posted 2025-11-20

Senior Panel Technician

Dynamics ATS
Laws, CA

Senior Panel Technician   JOB-10044578   Anticipated Start Date 10/27/2025   Location Kennedy Space Center, FL   Type of Employment Contract-to-Hire   Employer Info Clien…

View Details
Posted 2025-10-31

Staff Commercialization Manager

zoox
Foster, CA

This role functions as the lead responsible for driving the commercial success and market health of Zoox's service in key launch cities. Operating with an entrepreneurial, metrics-driven mindset, thi…

View Details
Posted 2025-11-18

Radiologic Technologist- Flex (West Pod)

GoHealth Urgent Care - UCSF Health
Eureka, CA

Its fun to work in a company where people truly BELIEVE in what they are doing! Were committed to bringing passion and customer focus to the business. Sign on bonus up to $5000 ( for eligi…

View Details
Posted 2025-11-21

Discover Eureka: Your Adventure Awaits as a PT!

NurseRecruiter
Eureka, CA

Physical Therapist Allied job in Eureka, CA Hey! I found an amazing travel PT job in Eureka, where you can experience the stunning beauty of the Redwoods and the vibrant local culture. Picture yourse…

View Details
Posted 2025-07-30

AMS Solutions GTM Lead

ServiceNow, Inc.
Santa Clara, CA

It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today - ServiceNow stands as a global market le…

View Details
Posted 2025-11-20

Freight Forwarder, Air Export Gateway

DSV - Global Transport and Logistics
Torrance, CA

DSV - Global transport and logistics In 1976, ten independent hauliers joined forces and founded DSV in Denmark. Since then, DSV has evolved to become the world's 3rd largest supplier of global sol…

View Details
Posted 2025-07-31

Field Operations Technician

Synergy Resource Group
Camarillo, CA

Our client has provided mission critical water infrastructure services for water utilities, farmers, and businesses in Southern California and the Central Coast for many years. They offer a compet…

View Details
Posted 2025-09-10