• Quality Auditor

    Job Locations US-MA-Peabody
    Posted Date 1 month ago(5/20/2019 2:29 PM)
    Job ID
    # of Openings
    Regular Full-Time
  • Overview

    BK Medical is a leading provider of ultrasound-based, intraoperative guidance for surgical procedures within the U.S. and international healthcare markets. Reporting to the Sr. Director of Regulatory & QA, the Quality Auditor will initiate and implement all quality improvement activities relating to audits


    • Bachelor's Degree in related technical discipline.
    • ASQ CQA/CQE or similar - Preferred
    • Lean Six Sigma Black Belt certification - preferred
    • 10 years of operations experience in industry is required
    • Minimum 5 years of experience of quality management experience within the medical device, healthcare or similar regulated industry.
    • This position will require a minimum of 70% travel
    • While performing the duties of this job, the employee is frequently required to walk, talk, and/or hear
    • The employee is occasionally required to stand, sit, and use hands to finger, handle, or feel
    • The employee must occasionally lift and/or move up to 20 pounds
    • Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus
    • Work in office environment
    • May occasionally be required to perform job duties outside the typical office setting


    • Plan, direct and follow up on individual audits and develops audit checklists
    • Selects audit personnel
    • Keeps all individual audit records and maintenance
    • Presents findings to audited organization and requests corrective action responses
    • Reports findings, observations and trends in audit reports
    • Verifies the implementation of the proposed corrective action responses
    • Consult with team on resolution of audit findings, quality management and validation deliverables
    • Facilitate quality related internal project team meetings and calls
    • Conduct and support calls with customer auditors and quality representatives
    • Monitor and resolve supplier-related operational issues. Collaborate directly with Quality teams at manufacturing sites to ensure supplier performance is regularly reported and coordinate corrective actions where required.
    • Develop quality plans and protocols for product transfers to contracted manufacturing sites.
    • Audit and evaluate suppliers internal processes to assess overall compliance and regulatory requirements, including sub-suppliers. Communicate feedback to sourcing team and plant quality to improve operations.
    • Monitor the supplier selection process in accordance with the company guidelines.
    • Develop a world class Supplier Management Program using Six Sigma and Lean methodologies.
    • Act as key contributor to the supplier quality management process. Standardize where possible by conducting supplier audits, monitoring quality-related issues during supplier maintenance and supplier selection process.
    • Champion supplier continuous improvement initiatives with Global Commodity Sourcing and Plant Quality teams.
    • Participate in the selection of suppliers in the design and development phase as well as the production phase to ensure that the supplier's current and future capabilities will meet the company's needs.
    • Collaborate with Global Commodity and Plant Quality teams to develop and prioritize an auditing schedule ensuring that designated suppliers are audited for GMP's, ISO and quality standards.
    • Participate in supplier scorecard reviews along with Sourcing Manager and Plant Quality to assess suppliers on their ability to meet quality, delivery, and service levels
    • Conduct supplier audits through the SCAR program to ensure suppliers implement and maintain any necessary corrective action program and ensure timely closure of SCARs.
    • Develop and maintain an SPC program and evaluate results for continuous improvement and process validation.
    • Prepare supplier-related quality metrics for presentations and periodic reviews
    • Ensure company policies are followed and enforce company safety policies
    • No Direct Reports
    • Manage Project Teams
    • Matrix Supervisor of Resources on Projects


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