Quality Inspections Supervisor

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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