Quality Inspections Supervisor

Teleflex•Olive Branch, MS

17h•Onsite

About The Position

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.

Requirements

Minimum three years of experience with US and international medical device regulations, standards, and guidance documents.
21 CFR 820 US FDA Quality System Regulations.
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.
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.

Nice To Haves

Bachelor's or equivalent, or higher degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, and pharmacology), math, engineering, or medical fields, preferred.
Within the Medical Device Industry preferred.
Minimum three years of supervisory experience, preferred.

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