Job Description

Description

Departmental Manager providing direct management of supervisors, technicians, and QA/QC office staff. Allocates resources based on departmental plans & budgets. Responsible for hire/fire decisions within their department. Submits departmental budgets, performance/productivity targets, and reports on results. Measured against performance plan goals and objectives.

Duties and Responsibilities:

• Maintains the IMI quality assurance and quality control systems in a state of compliance. 

• Functions as the designated backup for management representative.

• Implements quality assurance and quality control systems, processes, and controls to constantly monitor and ensure the quality, safety, and continuous improvement of IMI’s global product portfolio. 

• Supports continuous product and process improvement through detailed failure analysis of non-conformances and implements effective solutions for product or process corrections through remediation action plans and CAPAs. 

• Provides direct oversight of customer complaints and other feedback to assure timely and complete responses to customer feedback.

• Develops and leads a strong quality assurance and quality control team providing effective leadership, support, training, and mentorship. 

• Establishes effective relationships cross-functionally across the company to integrate quality and regulatory affairs activities with the overall company goals, plans, and objectives. 

• Develops and implements quality programs and strategies that enhance the organization’s quality assurance effectiveness, lower operating costs, and improve overall quality. 

• Ensures an appropriate interface of the quality function to product development, manufacturing, supply chain, and other areas as required. 

• Conducts internal and external audits and facilitates 3rd party and regulatory inspections.

• Provides direct oversight of the supplier quality management program, including supplier qualification and supplier monitoring.

• Provides direct oversight of device history record files for timely and accurate review, approval, and product release.

• Provides direct oversight of non-conformances, manages the NCP database, and provides guidance for the resolution of non-conformances. Chairs the regular management review board meetings.

• Provides and exemplifies active management by providing QC staff and QA direct reports with leadership, guidance, and counsel; documented by employee annual reviews and annual Job performance plans (at a minimum).

• Other duties as assigned.

Requirements

5+ years of progressive quality leadership experience in an FDA regulated medical device environment, including 3+ years of managing others.

• Bachelor’s degree in science, math, business, or engineering discipline; or equivalent.

• Advanced understanding of medical device quality systems requirements, specifically knowledge of current ISO and FDA requirements.

• Experience in the development of an organizational culture that promotes and sustains quality as an element of superior business performance.

• Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization in a medical device environment.

• Extensive experience in GMP and other regulatory compliance requirements.

• Ability to accurately complete visual inspections.

Preferred Qualifications: 

• Master’s degree in an engineering or science discipline or equivalent work experience.

• Has developed and trained cGMP/GDP to FDA oversight companies.

• Relevant certification(s) from recognized organizations such as ASQ (American Society for Quality), e.g., but not limited to CQA, CQE, and CQM.

• Six Sigma or Lean Six Sigma black belt.

• Lean manufacturing.

• Experience/training benchmarking all areas of quality assurance and regulatory affairs.

• Experience and competence in reading and understanding drawings, specifications, and performance requirements.

Physical / Mental Demands:

• Working conditions are normal for an office environment.

• Work may require weekend and evening work.

• Visual ability to make visual inspection decisions.

• Work under stress in a fast-paced environment.

• Must be alert, able to concentrate, and use good judgment.

• Must be able to work under conditions that require sitting, standing, walking