Director of Quality Control

Location: Pittsburgh, PA

Job Type: Full Time / Permanent

The Director of Quality Control is responsible for ensuring the quality management system is established, implemented, and maintained in accordance with relevant regulatory standards and established procedures. This position will implement, foster, and lead a culture of Total Quality Management that supports current business priorities and enables the company’s future growth.

Responsibilities:

  • Ensure that the Quality Management System is established, implemented, and maintained in compliance with all relevant regulatory standards
  • Ensure that the Quality Management System supports current business priorities and improves upon it to enable and support the company’s growth
  • Report and communicate to management on the performance of the quality management system and any needed improvements or quality issues
  • Measure, track, and report on quality objectives
  • Resolve any deficiencies in the quality management system and implement a culture of continual improvement
  • Ensure the promotion of awareness of customer quality requirements throughout the organization
  • Represent the company on all matters related to quality, and host external regulatory and third-party audits
  • Manage a comprehensive internal auditing program and ensure that internal audits are performed no less than annually by an independent source
  • Prepare responses and corrective actions to external/internal audits as necessary
  • Manage and/or ensure the specified requirements of the following systems/areas are met: document control, external provider control, record control,  calibration, corrective and preventative actions (CAPAs), change control, customers complaints, customer feedback, internal auditing, logbook/notebook control, validation protocol, chemical inventory, training, proficiency testing, equipment control, reference standard/reference material control, data review and reporting, disaster recovery, and safety
  • Manage and monitor the corrective and preventative action programs and customer complaint system
  • Perform or manage out of specification (OOS) investigations; initiate corrective actions when OOS results or data are encountered
  • Notify customers within a specified time-frame when a break down in the quality system has impacted the integrity of data released
  • Manage and maintain all quality record such as laboratory certifications, documents, proficiency data, external audits, reports, training records, corrective action reports, change control, internal audits, customer complaints, etc.
  • Coordinate laboratory accreditation activities for new and existing accreditations and certifications
  • Communicate regulatory and quality management system requirements to management and laboratory personnel
  • Handle the maintenance, distribution, and control of the Quality Management System Manual (QMSM) and all internally controlled documents; review and
    revise the QMSM and internal procedures on an annual basis, and ensure that the QMSM contents comply with all relevant regulatory standards
  • Maintain a master list of current versions of all controlled documentation
  • Train personnel on the the company’s Quality Management System and relevant regulatory requirements, both upon initial hire and on an on-going basis
  • Maintain personnel training files and ensure all employees have documented training that is commensurate with job responsibilities; review training files annually.
  • Approve external providers and maintain the Approved External Provider List (AEPL); perform audits on critical external providers, when necessary
  • Act as the Health and Safety Officer, ensuring health and safety requirements are followed in accordance with regulatory requirements

Education & Experience:

  • Bachelor’s degree in science or engineering-related field; Master’s degree preferred
  • Minimum of 10 years of relevant quality experience with 7+ years of leadership experience.
  • Relevant experience may be substituted for education
  • Must have experience working with medical devices and the operating software
  • Experience with leading FDA and other agency regulatory inspections a plus
  • Expertise in quality principles and practices
  • Five years of progressive people leadership and workforce engagement
  • Experienced in transforming and improving Quality processes, systems and culture with a demonstrated track record of process and productivity improvement and successful results with developing and implementing change initiatives
  • A keen interest in a fast-paced scientific learning environment with an emphasis on applying new skills
  • Well versed with 21 CFR 820, cGMP, ISO 13485 2016, ISO 9001 2015, IEC 62304, ISO 14971, MDSAP, CMDCAS, EU MDD/MDR, and other global medical device regulations
  • Excellent communication/presentation skills
  • Strong leadership and influencing skills to drive results in a highly matrixed organization
  • Ability to mobilize key stakeholders around the Quality vision and strategy by engaging cross functional leaders and teams
  • Highly results oriented and focused on business priorities
  • Strong change management and transformation skills; team oriented work ethic
  • Solid understanding of Microsoft Office Suite

 

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