Senior Quality Engineer - Contract
- 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.
The Senior Quality Engineer is responsible for the quality assurance of product design and supplier controls / performance. He / she must understand and be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. He/she initiates and facilitates improvements to the quality system while providing technical support to R&D, Manufacturing, and Supply Chain. This position serves as a Quality representative on new product development and provides technical support and leadership of quality deliverables. Also responsible to support R&D and Operations during all product development phases and support creation of design controls as well as process qualification/validation activities, statistically sound sampling plans and process control plans including inspection/test method development and product investigations resulting from field complaints.
Ensure that vendors / suppliers deliver quality products, materials, and services in accordance with specifications, purchase orders, and quality agreements. Monitor parts from purchasing through the manufacturing cycle. Communicates and resolves supplier-related problems as they occur. Assists in evaluating suppliers’ performance and provides feedback.
Support activities associated with supplier quality within a medical device environment. Collaborates with Regulatory, Supply Chain, Quality, Manufacturing, Engineering, and Customer Support for compliance to all specifications. Develops, applies, and reviews procedures in accordance with 21 CFR 820 and ISO 13485. Collaborates with new & existing product development teams to ensure quality standards are met. Support and/or lead supplier quality activities such as supplier qualification, supplier audits, inspection plans, root cause analysis, CAPA investigation, and supplier performance monitoring.
DUTIES & RESPONSIBILITIES
- 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 (eg. EN 14971)
- Participate in Usability Engineering and planning documentation (eg. EN 62366/ISO 62366)
- Interface with the core team 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
- Create Quality Plans
- Statistics; sampling plans, Statistical Process Controls, Data Analysis, process capabilities, Gauge R&R and other methodologies
- Perform DHF/DHR review for product release.
- Assist the Quality Department on an as-needed basis.
- Performance management
- Bachelor’s degree (or equivalent experience) with 12 plus years of related experience
- Certified Quality Engineer a plus
- Certified ISO 13485 Lead Auditor a plus
- Able to travel up to 10 % of the time
- Experience with the creation of Procedures, Protocols, Test Reports, and Work Instructions
- Participate in Risk Analysis (Design/Process) meetings and action requirements
- Ability to manage priorities and workflow in a rapidly changing environment
- Experience working in a cross-functional team environment
- Experience with robotics/software a plus
- Experience with Medical Device Manufacturing a plus
- Excellent organizational, problem-solving, and analytical skills
- Excellent verbal & written communication skills
- Good interpersonal skills
- Participate with internal quality audits
- Other duties as assigned by Quality Manager
- Experience with medical instrumentation and disposables, in a regulatory environment
- Working knowledge of basic quality systems regulations such as QSR and ISO.
- Proficient technical writing skills and use of documentation programs (Example Office Windows, Excel, Access, Power Point, etc.).
- Working knowledge of fundamental quality and statistical tools
- Possess excellent interpersonal and communication skills with the ability to develop trust, respect and confidence with internal and external customers.
- Knowledge of good manufacturing practices (GMP) and applicable Quality System.
- Attendance and Punctuality are essential function of the position.
- 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 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.