Interesting position posted at VERB today:
Quality Engineering Manager - Post Market at Verb Surgical Inc.
Our Quality Leader will drive exceptional product quality, safety, and reliability through the quality, manufacturing and service teams into the product. This important technical position will have direct influence on component, assembly, and final product quality for R&D and production builds and release to market. This individual will manage a team of highly talented quality engineers and will actively participate in risk management, design for quality and manufacturing requirements, process/technology development, process verification/validation, inspection verification, test method validation, post market surveillance, complaints handling, and associated documentation. The Quality Leader provides coaching and mentoring to engineers and other project team members on the Quality Management System and compliance to external standards.
Key Interfaces
Interact on a daily basis with Manufacturing/NPI, Supplier Quality, Servicing, as well as Marketing and the Program Management team to drive quality into the product design, manufacturing and servicing aspects.
Responsibilities
• Lead manufacturing quality and post market surveillance function for Verb Surgical Products
• Work with Product Development, Manufacturing/NPI, Quality & Purchasing teams to develop and execute Quality Engineering activities to meet commercial milestones
• Support the analysis and evaluation of business situations, production and service capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective.
• Review technical problems and departmental procedures and recommends solutions to problems or changes in procedures.
• Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485 and 21CFR 820.
• Train and mentor engineers and other project team members on best practices in quality engineering and regulatory compliance to external standards.
• Ensure maintenance of and compliance to the most recent versions of all applicable international quality system and product quality standards.
• Provide guidance about Six Sigma principles (Sampling, Acceptance, DOE, Statistical Process Control, Root Cause Analysis, FTA, control charts, capability analysis).
• Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures or tools as necessary.
• Assist in the development, improvement, and management of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, nonconforming materials, product lot release testing, and finished goods control. Identify and develop test methods and fixtures as needed.
• Participate in internal audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.
Competencies
• Technical, Computer and Practical Skills
• Through applied knowledge of ISO 13485, ISO 14971, IEC 60601 standards and 21 CFR 820 and MDD regulations.
• Fluent in a wide variety of Quality tools such as 8D, 6S, 5 Why Analysis processes.
• Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software including Minitab and ReliaSoft applications.
• Working knowledge of statistics for R&D, quality, reliability and inspection.
• Comfortable and effective in a startup environment.
• This position requires excellent verbal, written (English) and interpersonal communications skills with proven ability to translate technical information into effective procedures, plans, specifications and agreements.
• Ability to effectively present information in one-on-one and small group situations to supplier personnel, partners, consultants and employees at all levels of the organization.
• Ability to read, analyze, and interpret applicable scientific and technical journals, and legal documents. Ability to respond to common inquiries from auditors, notified bodies, regulatory agencies, or members of the business community.
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