Job Description
Position Summary
Growth, 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
implement 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.
Principal Responsibilities
• Manage, supervise, and prioritize 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 implement 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 gauges. 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
Education / Experience Requirements
• Bachelor's 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.
Specialized Skills / Other Requirements
• Minimum three years of 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 judgment
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 organizational 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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