Expected Travel: Up to 10%
Requisition ID: 11261
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position SummaryGrowth, Culture, People and Careers: this is the Teleflex Advantage.
In this exciting role as a Quality Supervisor, you will have responsibility for leading teams through Quality System Transformation by defining and trending metrics. This role will lead multiple projects within a larger program with a focus on creating more usable and simpler to follow processes, reducing burden within our quality systems and driving efficiency.
• Ensures all testing & quality requirements related to all product inspections meet company and regulatory requirements.
• Work collaboratively with cross functional teams to track data, identify improvement projects and implementation to improve Key Performance Indicators.
• Schedule and participate in activities to support and maintain compliance with applicable regulatory and Quality Management System requirements.
• Provide technical leadership, daily supervision, training development, and certification of inspectors, while coordinating and prioritizing production routine testing, product release, and processing non-conformances.
• Manage, supervises and prioritizes Quality Inspector activity in support of routine testing, product release, incoming inspection, process non-conformances, etc.
• Assist in ensuring all lots of finished products distributed at the NADC meet all internal specifications, customer expectations, and regulatory requirements.
• Provides training development where needed.
• Assist as a technical expert in relevant technical issues, protocols, SOPs, methods, etc.
• Manage and implements cost improvement projects within the department and in support of internal customers.
• Track, report, & improve key quality indicators for quality compliance, productivity, and efficiency.
• Provides input to annual spending and headcount budgets.
• Manages and acts as the contact for functional groups, nonconforming products, and production issues
• Performs Non-Conformance (NC) investigations and Corrective Action / Preventative Actions (CAPA).
• Participates in FDA inspections, ISO certifications, surveillance audits, etc.
• Manages performance review for direct reports within assigned time frames.
• Coordination and/or complete calibration of test equipment and gages. Maintain calibration records and work with calibration vendors. Assist with determining gauge requirements.
• Administer customer complaint investigations and documentation as needed.
• Assist in enforcing all local, state, federal, and safety regulations/policies/procedures.
• Complies with all policies/procedures/practices through consistent application of sound Quality Assurance principles.
• Ensures compliance with quality policies/procedures/practices
• Provide other departmental support as requested by the immediate supervisor.
• Adhere to and ensure compliance with Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
• Bachelors or equivalent, or higher degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields, preferred.
• 5-7 years of quality assurance experience in a manufacturing or distribution environment. Within the Medical Device Industry preferred.
• Minimum three years of supervisory experience, preferred.
• Minimum three years experience with US and international medical device regulations, standards, and guidance documents. Including:
o 21 CFR 820 US FDA Quality System Regulations.
o ISO 13485 Medical devices – Quality management system – requirements for regulatory purposes.
• Project Management skills and experience.
• Must have strong written and verbal communication skills.
• Must be able to effectively present at staff and department meetings.
• Knowledge of MS Office Suite.
Lead
• Has a Sense of Purpose & Inspires others
• Has a desire & ability to “step up”
• Takes accountability
• Demonstrates critical judgement
Engage
• Communicates with Impact
• Builds and sustains relationships
• Plans and Organizes
• Is present & available
Develop
• Develops Leaders
• Builds High Performance people & teams
• Invest in personal growth
• Develops Organization capability
Improve
• Creates value for the customer
• Demonstrates Continuous Improvement via results.
• Creates a culture of inclusion & involvement
• Makes the tough calls when organizations are not performing
Demonstrates Functional Mastery
• Adept at relationship building across functions and geography to effectively work with and leverage centers of excellence.
• Excellent computer skills (MS Word, Excel, and PowerPoint)
• Detail oriented and strong data driven analytical approach to Quality processes
• Ability to communicate positively and professionally with employees at all levels of the organization
• Resourceful and well organized. High energy level, comfortable performing multifaceted projects in conjunction with day-to-day activities.
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At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
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