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Permanent

Quality Assurance Manager

  • Location

    San Diego

  • Salary

    US$150000.00 - US$170000.00 per year

  • Sector

    Compliance

  • Job Ref

    29525

  • Contact

    Dustin Graham

  • Published

    17 days ago

Overview

The QA Manager is responsible for overseeing the activities of their assigned team(s) and individually performing tasks to ensure the effectiveness of the Quality Systems. This position manages work assignments and processes to meet productivity standards, quality goals and department objectives. Responsible for providing support to staff, resolving operational and performance issues, and implementing improvements to operations, processes and the work environment. Trains and onboards new staff, assesses performance of direct reports and provides development opportunities. Ensures business goals, deadlines and performance standards are met. Communicates and collaborates with staff, department leadership, and other Autoimmunity functions to meet goals and produce the highest quality products and services. Ensures staff comply with company policies and expectations.

Key Accountabilities
Department Management:

  • Manage personnel including recruitment, interviewing, selection, training, coaching, development, coordination of assignments and workload priorities, goal setting, termination, and performance management.
  • Educate and broaden the quality knowledge within the teams; develop and deploy personnel skill assessment and training plans.
  • Ensure regular and meaningful communication throughout team, and with department management, through effective use of one-on-one meetings, team meetings and other forms of formal and informal communication.
  • Proactively manages employee relations issues; uses judgement in consulting with department leadership and Human Resources.
  • Author, implement, and ensure maintenance of departmental procedures, work instructions, and templates associated with the quality assurance activities.
  • Prepare reports to management on the performance of the quality system, including management-requested reports and management review meetings minutes.
  • Assist in the development of department budget and monitors department expenditures.

Continuous Improvement:

  • Trend, analyze and identify continuous improvement opportunities and coordinate/perform actions to improve processes and metrics; proactively manage critical quality issues.
  • Contribute, manage, and execute proactive quality strategies and plans.
  • Ensure that risks to quality systems are identified and mitigated through effective controls.
  • Influence and drive cross-functional projects for quality improvement
  • Recommend quality objectives then ensure they are monitored and achieved.
  • Ensuring QMS effectiveness through audits, data analysis, and projects to achieve company and department objectives.

Audits:

  • Set and oversee the annual schedule of internal quality and external audits.
  • Host and guide quality audits. o Communicate progress and drive timely corrective actions from both internal and external audit findings.
  • Respond to client and other external regulatory agencies to provide supporting information as needed

Quality Assurance Activities:

  • Facilitate effectiveness of quality management system activities for corrective and preventive actions, internal & external audits, document & records management, compliance administration, stop shipment management, change management, product release, quality system training, management review, supplier management, quality improvements, quality monitoring and reporting, and nonconformance/deviations management.
  • Ensure the conduct of timely investigations for quality events, such as nonconformances, deviations, and audit findings.
  • Ensure the meticulous review and approval of product quality and quality systems documentation.
  • Develop systems to track, trend, report and reduce nonconforming situations. Identify all batch nonconformance and initiate appropriate actions for those nonconformances
  • Provide advice within the organization on the best tactical direction issue to maintain Quality Management System effectiveness in alignment with company mission, values, and business goals.
  • Actively engage with other department functions to ensure that QMS and quality improvements are well supported to achieve expectations; maintain effective and professional communication between all parties.
  • Make informed data-driven quality decisions without oversight.
  • Acquire and maintain current knowledge of regulatory compliance and industry practices through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches.
  • Facilitate a quality culture and promote collaboration, quality requirements understanding and continuous improvement.
  • Detailed review and approval of quality documentation.

Education:

  • Bachelor's degree in biology, biochemistry, life science, engineering, or equivalent required. Advanced degree preferred.
  • Certified Medical Device Auditor (preferred)

Experience:

  • A minimum of 6 years of progressive quality experience in in-vitro diagnostics and/or medical device industry.
  • At least 5 years of experience managing or leading a team required, preferably in a regulated manufacturing environment.
  • At least 3 years of successful auditing and inspection experience including managing the preparation for and hosting of Regulatory Inspection including successfully resolving issued nonconformance/violations