- 47201 Lakeview Blvd, Fremont, CA 94538, USA
THINK Surgical®, Inc., a privately held U.S.-based medical device and technology company, develops, manufactures and markets active robotics for knee replacement surgery. The TSolution One® Total Knee Application performs automated preparation of the bone and joint surface and supports a versatile, open platform providing surgeons the flexibility of using a variety of implants. The TSolution One Total Knee Application system is comprised of TPLAN®, the 3D pre-surgical planning workstation, and TCAT®, the active robot that helps the surgeon execute each patient’s individual preoperative plan with consistent results. These evolutionary technologies are advancing total joint replacement surgery.
The TSolution One® core technology has been used in thousands of successful total joint replacements for both hip and knee worldwide. The TSolution One® Total Knee Application was FDA cleared in October 2019. THINK’s second-generation TSolution One Total Knee Application received FDA clearance in November 2020, and is commercially available in the United States.
This position is a critical role that is responsible for investigating, planning, and implementing improvements in and/or additions to products and processes that directly impacts safety, quality, and productivity. The Quality Engineer must have good understanding and ability to apply the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. They must have a passion to develop, maintain, and continuously improve our standard practices. They will collaborate with and provide guidance to new & existing product development teams to ensure products are developed with high quality consideration.
DUTIES & RESPONSIBILITIES
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Develop product/process assurance plans. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Will be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet 21 CFR Part 820 and ISO 13485 requirements.
- Support activities associated with supplier quality such as supplier qualification, supplier audits, inspection plans, root cause analysis, CAPA investigation, and supplier performance monitoring.
- Participate in Material Review Boards (MRB). Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
- Track quality trends and KPIs for various processes and initiate action items to resolve issues.
- Perform DHF/DHR review for product release.
- Provide training and support for quality system processes and quality engineering practices.
- Provide active support for internal, third party and customer audits. This requirement includes the post audit requirements for reviewing, dispositioning, mitigating, and incorporating any observations, non-conformances, opportunities for improvement and potential gaps/preventive actions.
- Assist the Quality Department on an as-needed basis.
- Other duties or projects as required to meet company’s objectives.
- Bachelor’s degree (or equivalent experience) with 3-5 years of related experience
- Working knowledge of basic quality systems regulations.
- Experience with the creation of Procedures, Work Instructions, Forms, Protocols, and Test Reports
- Ability to manage priorities and workflow in a rapidly changing environment.
- Experience working and troubleshooting with cross-functional teams
- Strong organizational, problem-solving, and analytical skills
- Strong verbal & written communication skills
- Proficient technical writing skills and use of documentation programs (Example Office Windows, Excel, Access, Power Point, etc.).
- Strong interpersonal skills
- Certified Quality Engineer
- Certified ISO 13485 Lead Auditor
- Experience supporting robotic products and/or complex devices
- Experience with medical instrumentation and disposables
- Working knowledge of fundamental quality and statistical tools
- Working knowledge of ISO10993
- Excellent interpersonal and technical skills with the ability to develop trust, respect, and confidence with internal and external customers.
- Experience with Medical Device Manufacturing and knowledge of good manufacturing practices (GMP)
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 to 10<% Travel).
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 made to enable individuals with disabilities to perform the essential functions.
THINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow’s leading orthopedic solutions today, we would love to hear from you.
THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.