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 Teleflexs Code of Conduct all Company policies rules procedures
and housekeeping standards

Education / Experience Requirements

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.

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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