Associate Director, Quality Management System

Company: bioM--rieux SA
Location: San Jose
Posted on: May 27, 2023

Job Description:

Associate Director, Quality Management System The estimated salary range for this role based in California is between $165,200 and $198,200 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Various voluntary benefit offerings
• Parental leaves The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases > 6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic. Specific Diagnostics, a bioM--rieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific's solution provides results 2 days sooner than existing methods, saving patients suffering from drug-resistant.
  
  THE JOB
  
  PRIMARY DUTIES
  • Serve as the backup Site Quality Management Representative, for the manufacturing facility and lead assessments of the Quality Systems for compliance (e.g. customers, FDA, ISO Registrars), and ensure that such assessments are conducted in accordance with established policies and procedures to maximize their benefit to bioM--rieux, Inc.
  • Lead or facilitate teams to accomplish the deliverables, milestones, and objectives meeting the plans and schedules ensuring that any changes are communicated and agreed to by the teams and project sponsors for the St. Louis site. This includes teams to standardize processes at North America sites to ensure the North America ISO 9000 & 13485 registration is maintained.
  • Lead or support the execution of the site Quality Management Review and Internal Audit Program and implementation of the Corporate Quality Manual, directives and processes.
  • Develop and maintain the Corrective and Preventive Action programs including necessary procedures, records, manuals, and trend reports.
  • Develop and maintain the customer complaint trending and compliant investigation processes including necessary procedures, records and reports. Ensure the timely response and closure of complaint investigations and provide oversight of complaint records.
  • Recruit and develop employees who will function well within our corporate culture. Evaluate and direct employees to ensure job satisfaction and improvement. Encourage staff to take initiative, be proactive, and strive to improve their work and the processes that shape their work.
  • Configuration control and management of all documentation and data required to manufacture products produced and distributed from the St. Louis, MO. This includes the Device Master Indexes and the assignment and maintenance of Part Numbers and Bill Of Materials (BOM) in SAP. Assure that this documentation meets the requirements of 21CFRPart 820 Quality System Regulation, In-Vitro Diagnostic Directive and other country specific language requirements.
  • Develop and implement Quality and Compliance training programs that provide necessary organizational knowledge to achieve company and regulatory objectives including compliance.
  • Establish, maintain, and improve reports of quality data such as customer satisfaction, business level quality, and functional area quality indicators to assist the continuous improvement of quality and analyze them to assess the effectiveness of both the company quality system.
  • Manage site compliance projects as needed.
  • Manage and adhere to department budget. KNOWLEDGE, EXPERIENCE & SKILLS
    • Requires a Bachelors Degree in scientific field, Masters Degree preferred.
    • Requires a minimum ten (10) years progressively responsible quality systems experience in an FDA regulated manufacturing environemnt (such as medical device).
    • Must have a expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
    • Requires a minimum of 5 years experience managing quality teams and leading people.
    • Must possess strong interpersonal, written and oral communication skills.
    • Certification in one of the following is desired: CQE, CQA, CBA, CMQ/OE, or Six Sigma Black Belt.

Keywords: bioM--rieux SA, San Jose , Associate Director, Quality Management System, Executive , San Jose, California