QA Engineering Supervisor

Teleflex Incorporated•Olive Branch, MS

About The Position

In this exciting role as a Quality Engineer 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. Work collaboratively with cross functional teams to track data, identify improvement projects and implementation to drive improvements to Key Performance Indicators. Schedule and participate in activities to support and maintain compliance with applicable regulatory and Quality Management System requirements. Support the maintenance and development of the Corrective And Preventative Action (CAPA) and internal Non-Conformance system to support the overall facility quality management system. People supervision and process management of elements under your responsibility.

Requirements

Bachelor’s Degree with 5+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 3+ of work experience in Quality and/or experience in a regulated
Knowledge of Quality Systems Requirements (ISO 13485, CFR 820 & LATAM)
Knowledgeable of Board of Pharmacy and NABP requirements
Experience and Knowledgeable working with product holds, nonconforming products, and recalls
Experience and knowledgeable working with NC’s (nonconfromances) and CAPA’s
Internal / External QMS Audit experience
Process Development Experience
Project Management Experience
Quality Agreements
Schedule management
Ability to become NABP Designated Representative.
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 HR processes
Effective with combining Business and HR Acumen to build organizational capability
Able to support employees on multiple shifts; ability to be flexible with scheduling outside of normal office hours. Core hours are 8 to 5 but on occasion supporting an off shift maybe required.
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.
Has a Sense of Purpose & Inspires others
Has a desire & ability to “step up”
Takes accountability
Demonstrates critical judgement
Communicates with Impact
Builds and sustains relationships
Plans and Organizes
Is present & available
Develops Leaders
Builds High Performance people & teams
Invest in personal growth
Develops Organization capability
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

Nice To Haves

Green Belt / Black Belt Certificate (or experience) preferred
Experience with SAP/Blue, Younder, and eQMS systems, like Veeva Vault, Agile, Mastercontrol applications (desirable)

Responsibilities

Ensures the quality assurance programs and policies are maintained and modified regularly.
Ensure products adhere to company and industry quality standards
Drive proactive Quality improvements in partnership with all related business functions.
Formulate strategic plans to increase productivity in the business
Works within an operations team to identify and implement effective controls to support the development, qualification, and distribution of products to meet or exceed internal and external requirements
Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
Perform statistical analysis to determine process capability and to analyze trends
Maintains schedules for projects; identifies problems and recommends solutions to all project activities.
Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as ship holds, service errors, line yields, final release, supplier performance and customer experiences to internal product improvement teams
Acts as an effective leader and team member in supporting quality disciplines, decisions, and practices.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Support audits, CAPA/NC/MRB investigations and reports
Management of quality process within the facility and supervision of personnel
Previous experience overseeing a team, quality supervisor experience is preferred
People management skills, conflict resolution and results oriented.
Perform other related duties as assigned