The
Quality Manager provides technical and administrative guidance to Quality Assurance, Servicing, and suppliers of finished medical devices and spare parts. This roles assures product conformance to established requirements and standards through appropriate inspection and test activities, coordinates quality planning, inspection method development and defect prevention/corrective action processes for new and existing products. It also identifies and solves product and process problems and supports the global servicing team.
How You'll Create Impact
- Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents.
- Formulate, write and maintain procedures, specifications and standards for the quality control of products including procurement, inspection methods and visual acceptance standards, as well as servicing and distribution activities for various products .Coordinate the maintenance of the calibration program for all inspection tools and gauges to comply with division and corporate Good Manufacturing Practices.
- Develop and administer effective data collection and reporting system to meet regulatory requirements and management information needs.
Control further processing, delivery or use of nonconforming products until deficiency or unsatisfactory condition has been corrected. - Provides resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
What Makes You Stand Out
- Lead and motivate team members through feedback and stretch assignments.
- Establishes and maintains high levels of credibility.
- Collaborates effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results.
- Teamwork and customer focus oriented.
- Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and direct people.
- Must possess good writing skills and be familiar with both the scientific and vernacular vocabularies.
- Good knowledge of applicable government specifications, standards and regulations such as FDA QMSR and ISO standards.
Your Background
- This position requires a Bachelor's Degree preferably in engineering or a related discipline with 6-8 years of work experience in quality functions, or an advanced degree (ex. Masters) in a related discipline with 4-6 years experience.
- Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.
- Quality Engineering Certification (ASQ) and/or Lead Auditor Certification a plus.
Travel Expectations
Up to 10%
Expected compensation for the role is: $128,000 - 157,000 base salary per year plus performance bonuses.
