CooperVision - Scottsville, NY

posted 4 months ago

Full-time - Senior
Scottsville, NY
Merchant Wholesalers, Durable Goods

About the position

The Senior Manager of Quality Engineering & Systems at CooperVision is responsible for ensuring the effective implementation and execution of production quality controls at the Scottsville, NY manufacturing facility. This role encompasses overseeing various Quality Management System processes, including Quality Engineering, Complaints, Document Control, Record Retention, Training, Internal Audits, and Supplier Management, to ensure the distribution of safe and effective products that meet regulatory requirements and industry standards.

Responsibilities

  • Develop, implement, and maintain processes in accordance with quality management system standards and regulatory requirements.
  • Employ quality assurance methodologies to support Engineering, Manufacturing, and Regulatory functions.
  • Facilitate effective problem solving and root cause methodologies to resolve quality issues.
  • Ensure all quality requirements are met for products manufactured, packaged, and distributed from the facility.
  • Manage the Internal Audit program and ensure compliance with FDA and international quality system requirements.
  • Act as Deputy Management Representative and subject matter expert in various quality-related areas.
  • Oversee staffing, planning, training, and employee relations to achieve objectives and key performance indicators.
  • Foster a work environment that empowers team members and models CooperVision values.

Requirements

  • Leadership skills to define roles and responsibilities and hold team members accountable.
  • Strategic planning and deployment skills to execute tactical plans and deploy resources effectively.
  • Strong management skills for planning, leading, delegating, and controlling processes.
  • Excellent verbal, written, and interpersonal communication skills.
  • Knowledge of regulatory requirements, particularly ISO 13485 and US FDA regulations.
  • Problem-solving skills to manage processes and drive improvement.
  • Strong measurement background for using measurement techniques and evaluating process variation.
  • Customer relationship management skills to capture and analyze customer needs.
  • Training and development skills to create and deliver effective training materials.
  • Proficiency in Microsoft Office Suite, database software, and statistical analysis software.

Nice-to-haves

  • Certified Manager of Quality and Operational Excellence (CQM/OE) certification.
  • Certified Quality Engineer (CQE) certification.
  • Certified Quality Technician (CQT) certification.
  • Experience with structured problem-solving methodologies like Six Sigma or Shainin Red X.
  • Skills in supplier management and risk management.

Benefits

  • Health insurance
  • 401k retirement plan
  • Paid holidays
  • Professional development opportunities
  • Employee discounts
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