Senior Quality Engineer
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.
- Work with product development teams to develop measurable goals for quality
- Complaint and CAPA investigation
- Perform Supplier audit and Supplier performance monitoring
- Participate in the risk management process ensuring, when applicable, that hazards are adequately mitigated in product and process quality plans
- 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.
- Other duties or MDD projects as required to meet company s objectives
- Bachelor s degree (or equivalent experience) with 3-5 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 Director
- 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 Standards.
- Attendance and Punctuality are essential function of the position.