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
Skills Required
- 5+ years progressive quality leadership experience in an FDA regulated medical device environment
- 3+ years of managing others
- Bachelor's degree in science, math, business, or engineering or equivalent
- Advanced understanding of medical device quality systems requirements, specifically knowledge of current ISO and FDA requirements
- Experience with product development lifecycle including concept, design, verification, and validation for medical devices
- Extensive experience in GMP and other regulatory compliance requirements
- Ability to accurately complete visual inspections
- Master's degree in engineering or science (preferred)
- Experience developing and training cGMP/GDP under FDA oversight (preferred)
- Relevant ASQ certifications (CQA, CQE, CQM) (preferred)
- Six Sigma or Lean Six Sigma Black Belt (preferred)
- Lean manufacturing experience (preferred)
- Experience benchmarking quality assurance and regulatory affairs (preferred)
- Experience reading and understanding drawings, specifications, and performance requirements (preferred)
What We Do
International Medical Industries, Inc. (IMI) is a global leader in the manufacturing of medical devices specialized for the pharmaceutical compounding industry. Founded in 1967, IMI provides high-quality, American-made sterile devices, including tamper-evident technologies for IV syringes and oral dispensers. Their mission is to improve medication safety and security from the pharmacy to the patient through innovative sterile adapters, caps, plugs, and needles.
