Quality Assurance Manager

Location

Lehigh Acres, FL

Description

The Quality Assurance Manager is responsible for developing, implementing and maintaining the Quality Management System at Inovo, while driving process effectiveness and efficiency.

 ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop and maintain Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, MDD, Health Canada, etc.).
  • Establish and lead Quality team with the skills and abilities necessary to support the Quality Management System and the goals of the organization. 
  • Oversee the Quality Management System including complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration and control of nonconforming material.
  • Lead Quality Engineers in the implementation of an effective product development process that complies with design control requirements.
  • Establishe quality metrics monitoring, trending, response, and promotion to corrective actions as appropriate. 
  • Identify process improvement opportunities.  Implement and develop processes and procedures that create the greatest value for the organization. 
  • Promote a culture of quality and continuous improvement throughout the organization.
  • Partner effectively with Engineering and Manufacturing to ensure quality standards are being met.
  • Ensure site readiness for external audits.
  • Participate in inspections by regulatory agencies. 
  • Provides guidance across the organization to address compliance deficiencies.
  • Performs tasks in accordance with applicable requirements of the FDA Quality System Regulation and Medical Device Reporting, ISO 13485, MDD, CMDCAS and any other applicable regulations.
  • Duties, responsibilities and activities may change at any time with or without notice.

SUPERVISORY RESPONSIBILITIES:

This position is responsible for managing Quality Engineers, Quality Technician, and Quality Assurance Specialists and is responsible for their performance review. This position must also work well with the entire management team and functional area supervisors to ensure the accuracy of quality management system is accordance whit the regulatory requirements.

 PHYSICAL DEMANDS:

  • Ability to frequently sit, stand or walk an entire shift; climb or balance; and stoop, kneel.
  • Ability to lift and/or move up to 25 pounds, vision abilities as by this job include close vision, distance vision, depth.

WORK ENVIRONMENT:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Some of the work will require exposure to loud noises in the plant facility.

Requirements

QUALIFICATIONS, KNOWLEDGE, AND SKILLS:

  • Good problem identification and creative resolution aptitude.
  • Proven process development and project management skills.
  • Strong computer skills.
  • Hands on management style with the ability to work well cross-functionally. 
  • Ability to successfully establish priorities while working under pressure.
  • Excellent interpersonal skills including listening, writing, negotiation, facilitation, attention to detail.

 EDUCATION AND EXPERIENCE:

  • Bachelor's degree in Science or Engineering.
  • Minimum of 5 years of professional experience and understanding of product development, manufacturing, quality control and servicing in a medical device or pharmaceutical industry.
  • Minimum 3 years supervisory/ management experience, including hiring, training, coaching and performance management activities, five or more years of management/leadership and development experience preferred.
  • Working knowledge of domestic and international medical device regulatory requirements (FDA Quality System Regulation and Medical Device Reporting, ISO-13485, MDD 93/42/EEC, Health Canada regulations, etc.) required.
  • Experience in QMS remediation and integration activities preferred.

 CERTIFICATES, LICENSES, REGISTRATIONS:

  • Auditor Certificate preferred
  • CQA, CQM, CQE, preferred.
  • Six Sigma

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