Senior Quality Manager - new job in St. Louis, US

Senior Quality Manager
  • $120,000 - $150,000 per Hour
  • Permanent
  • St. Louis MO, US St. Louis SAINT LOUIS US 63122
Job Ref: JO000133167
Sector: Clinical
Sub-sector: Quality
Date Added: 14 September 2022

TITLE: Senior Quality Manager


One of our client's is currently searching for a permanent full-time Senior Quality Manager who will be responsible to ensure Quality and Compliance for Surgical Products, and to develop, maintain, and improve quality system procedures that comply with applicable B&L and regulatory standards in a medical device regulated environment. The successful candidate will be a quality leader with strong ability to drive sustainable process capability, and who can successfully implement an Advanced Quality process and metrics. Must have proven success in maintaining manufacturing sites certifications and compliance Year-over-Year, as well as strong Engineering/Operations Leadership skills.

Key Activities/Responsibilities

  • Manage Quality Organization including Quality Engineering, Quality Control, Quality Assurance, Calibrations, Metrology and Validation.
  • Develop annual quality plan to deploy quality goals and objectives that are linked to B&L Global Quality Policy and corporate strategic priorities.
  • Manage/control quality of product from receiving of materials, in process through finish product release.
  • Utilize metrics in QPI monitoring system to proactively identify risk, assess risk, implement any required mitigations, and drive continuous improvement.
  • Analyze workflows, process and systems to improve efficiency and effectiveness.

Required Education, Experience & Skills

  • BS Engineering or Science (Master’s degree preferred).
  • 10+ years of experience in an End-to-End Quality leadership position.
  • Minimum of 7-10 years of supervisory experience in an FDA regulated industry in a quality discipline.
  • 10+ years of Quality Engineering and Quality Assurance experience utilizing Quality Sciences and Regulations in health sciences industry
  • Medical Devices experience is required
  • Working experiencing implementing requirements from ISO 13485, GMPs, CMDR (SOR/98-282), JPAL, MDD and MDR are required
    • ISO 14001, OHSAS 18001, and other regulations are desired.
  • Working knowledge of FDA and International regulations and standards for medical devices, and experience with managing external agency inspections is necessary.
  • Training and experience in validation, auditing, statistics (DOE, SPC) preferred.
  • Training in problem solving techniques or Lean Six Sigma Green belt preferred.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

12/10/2022 12:00:00
USD 120000.00 150000.00 Hour
Contact Consultant:
Danielle Wilson

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