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Head of Quality Assurance

Company: Nachman BioMedical
Location: Newport Beach
Posted on: January 15, 2021

Job Description:

Head of Quality Assurance - Robotic Surgical Systems Establish and lead the QA department at the US operation of an established medical device company developing and manufacturing innovative surgical robotics systems that enable more precise and efficient placement of orthopedic implants. The experienced medical device QA Manager selected for this key position will have responsibility for implementing and managing a Quality Management System that complies with FDA and international regulations. The range of responsibility includes creating and managing the QMS, and overseeing the Quality Engineering, Design Control, and inspection staff. The position:

  • Create the site's QMS and obtain ISO 13485 certification.
  • Mange the Quality Department, including quality aspects of Design Control, manufacturing process, and customer interaction.
  • Serve as subject matter expert for the entire Quality System (CAPA, Product non- conformance, internal audit, document management, change control, etc.).
  • Assure compliance with regulatory requirements such as 21 CFR Part 820, ISO 13485 and 14971.
  • Lead the quality management review process, present content and ensure review is adequate to maintain an effective QMS that satisfies all regulatory requirements.
  • Coordinate and conduct external QA audits of critical suppliers.
  • Lead the complaint handling process, facilitate resolution, and implement effective containment and close-loop corrective/preventive actions.
  • Establish processes for monitoring the quality of manufactured product with consistency throughout the manufacturing process, and make needed corrections and improvements.
  • Ensure NPI projects are adequately supported by Quality Department from inception.
  • Prepare and evaluate trends in quality system to monitor effectiveness, including development of metrics and KPIs for quality that will drive system wide improvements.
  • Lead and support CAPA and QMS continuous improvement projects by collecting, analyzing and validating quality data. Required Qualifications and Skills:
    • Minimum of a BS in engineering, sciences, or related field 10+ years' experience in medical device Quality Assurance, including design and manufacturing, with a minimum of 5 years in a QA leadership role.
    • Extensive working knowledge of cGMP/QSRs, 21 CR 820, ISO 13485 and ISO 14971.
    • Strong working knowledge of design controls, document controls, design V&V, supplier selection and management, hazard analysis techniques, and regulatory approval methods.
    • Significant experience incorporating quality into new product development and introduction.
    • Previous experience with ERP systems, electronic document management systems preferred.
    • Excellent teamwork skills with proven ability to collaborate with cross-functional teamsHighly motivated self-starter needing minimal supervision.
    • Ability to travel up to 10%, depending on Covid pandemic conditions.

Keywords: Nachman BioMedical, Newport Beach , Head of Quality Assurance, Other , Newport Beach, California

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