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Head of Quality

Hyalex

Head of Quality

Lexington, MA
Full Time
Paid
  • Responsibilities

    Head of Quality Hyalex Orthopedics is seeking candidates to lead the Quality Systems/Quality Assurance function for the company.  In this role, the successful candidate will lead the development of Hyalex' Quality Management System from the ground up, including implementation of an electronic QMS/eDoc control system.  He/she will also guide product development teams through the Design Control process. This role will report to the CEO. As Head of Quality, this individual has primary responsibility for the Quality function for the Company.  This position oversees quality planning, creates and implements operating procedures and ensures employee training to those procedures. This position is responsible for Supplier Management and internal quality audits to measure the Company's compliance with internal procedures and governmental regulations, including FDA's Quality System Regulation, ISO 13485 and the MDD (and future MDR) requirements. The Head of Quality is also responsible for the QC inspection function for the Company and serves as the Management Representative for the Quality System. ROLE AND RESPONSIBILITIES

    • Key member of the leadership team.

    • Develop and oversee the Quality Management System.

    • Guide product development through the design control process.

    • Define quality planning from a quality systems perspective.

    • Manage the Company's Quality Control function, including hiring and managing mechanical inspection staff.

    • Work with Engineering and contract manufacturers to determine best methods for inspecting Hyalex products.

    • Qualify and monitor performance of contract manufacturers of Hyalex products and to maintain and update the Approved Supplier List (ASL).

    • Conduct internal and supplier quality audits.

    • Provide guidance to all functional areas of the Company to achieve ISO 13485 certification and pass FDA GMP inspections.

    • Measure and report on key quality system metrics for Hyalex Orthopaedics.

    • Train Company employees in Good Manufacturing Practices and ISO requirements.

    • Initiate preventive/corrective action initiatives and is responsible for tracking continuous quality improvement.

    • Serve as the Quality representative on Hyalex project teams.

    • QUALIFICATIONS/WORK EXPERIENCE

    • 5-10 years of experience in a Quality Assurance function in the medical device industry.

    • 3+ years' experience performing or managing quality control

    • Bachelors or master's degree or equivalent.

    • Thorough understanding of all relevant regulations including GMP, ISO and MDD requirements.

    • Successful history with FDA and ISO facility audits.

    • Knowledge of probability and statistics

    ABOUT HYALEX

    Hyalex Orthopaedics is an early stage, venture funded medical device company focused on developing and commercializing new products that feature HYALEX™ materials technology. The HYALEX technology is poised to change the orthopaedics industry through materials innovation and improved patient quality of life. The Hyalex team is comprised of industry leaders, R&D innovators, and experts who have launched multiple successful commercial products as well as a team of brilliant engineers and scientists who aren't afraid to ask questions, think outside the box and challenge the existing status quo in pursuit of excellence and breakthrough discoveries.

    Hyalex values are focused on teamwork, communication, innovation, integrity, and accountability and all team members strive to promote an inspirational and productive workplace.  Every team member's contribution is valued as we work towards a common goal of transforming the orthopaedic space.

       

    SENIORITY LEVEL

    Mid-Senior level

    INDUSTRY

    • Medical Device
    • Mechanical or Industrial Engineering
    • Chemical Engineering
    • Biotechnology

    EMPLOYMENT TYPE

    Full-time

    JOB FUNCTIONS

    • Quality Assurance