Senior Quality Engineer

Company: Meraqi Medical
Location: Fremont
Posted on: May 3, 2021

Job Description:

Job Description COMPANY OVERVIEW Meraqi Medical, Inc. (Meraqi) is a privately held company providing design, product development and manufacturing services to the medical device industry. C ompany Mission Statement: Meraqi Medical Inc.s mission is to be the partner of choice for medical device companies looking to bring innovative products to market. POSITION SUMMARY Ensures QMS processes are being followed according to established procedures. Participates as a team member in the product development process from concept through the life of the project Ensures project teams are utilizing Meraqi Medical Inc quality systems and appropriate regulatory requirements and standards throughout the project. ESSENTIAL DUTIES AND RESPONSIBILITIES Lead preparation efforts for internal and external audits Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
Designs and implements product and process documentation, including inspection plans Conducts feasibility studies of the design to determine ability to function as intended Investigates and evaluates material biocompatibility and appropriate methods of sterilization if applicable Maintains detailed documentation throughout all phases of research and development, design verification and validation, design transfer, and production on assigned projects Conduct risk analysis for products and processes under development Interface with customers to generate quality plans and supplier quality agreements.
Ensures outside supplier quality systems meet Meraqi medical Inc requirements and coordinates any activities with the supplier as needed Develops verification and validation test protocols Develops product submission documentation if required by the customer Participates in design reviews to ensure the design control deliverables for each phase are met Report quality system metrics to top management as required Supports various manufacturing activities and participates in the development, qualification of product/equipment and process Investigates and resolves issues with out of tolerance equipment Recommends changes to improve product quality and performance Meet assigned minimum weekly billable target Any other duties as assigned SUPERVISORY RESPONSIBILITY May supervisor inspection or other quality personnel formally or informally REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE Bachelors degree in Engineering is desired Minimum 5 years of medical device product design and development experience is required Demonstrated ability to bring products from concept to market Ability to interact with client companies in a professional manner Familiarity with FDA, QSR, and ISO 13485 medical device regulations and standards Familiarity with Minitab or equivalent data analysis package Working knowledge of probability and statistics Depth of knowledge in one or more clinical areas Depth of knowledge in one or more product areas Depth of knowledge in one or more technical areas (i.e. sterilization) Flexibility, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit CORE COMPETENCIES Communication Skills All verbal and written communications are concise, technically accurate, timely, and professional. Demonstrates strong verbal presentation and negotiation skills. Represents in a positive and professional manner. Expresses ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrates tact and diplomacy in communications. Demonstrates active listening skills and ability to resolve discrepancies with customers Management of Resources Well organized and uses time efficiently. Familiar with all reference materials and can locate needed information as necessary. Takes initiative for self-development. Prioritizes tasks effectively. Demonstrates initiative and creativity in the use of available resources. Customer Focus Provide professional, reliable and prompt service to internal and external customers Work in partnership with others to meet and exceed customer expectations. Interpret customer needs and take appropriate action. Follow through on customer inquiries in a professional and timely manner. WORKING CONDITIONS / PHYSICAL DEMANDS Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery, and tools. May lift up to 30 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in the Meraqi Medical Inc environment

The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required. External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis. Company Description Meraqi Medical's expert team brings decades of experience in developing and manufacturing medical devices including implantable leads and neurostimulators, single-use catheters, and minimally invasive surgical tools.

Meraqi's services include everything from early brainstorming, concepting, and prototyping, to clinical and commercial manufacturing; providing customers a single source for their development and manufacturing needs. Meraqi's business model is designed to be extremely flexible, serving customers ranging from startups to global medical device companies.

Meraqi was established by industry veterans who share an unyielding passion for medical device innovation and servicing customers. The name is derived from Meraki, a word used to describe doing something you love with soul and creativity; quite literally to put something of yourself into what you do. As such, Meraqi is all about a love for helping its customers bring new products and innovative technologies to clinicians and patients.

Keywords: Meraqi Medical, Fremont , Senior Quality Engineer, Other , Fremont, California