INGENYX - Quality Engineer 3 (Hybrid/Remote)

Teleflex•Trenton, GA

25d

About The Position

The Quality Engineer 3 provides Quality Engineering leadership and support to manufacturing as a lead Quality team member. The role coordinates and processes nonconformances and CAPAs, leads customer complaint investigations, guides process and product validations, evaluates customer change notifications, supports audits, and drives quality improvement initiatives. The position is responsible for complying with Ingenyx and local procedures and policies. The role leads quality activities related to Conductor Material Review Board coordination, inspection methods, nonconformance containment, correction and closure, and CAPAs. It serves as the primary customer contact for complaint communications and supports improvements based on complaint and quality trend data. The Quality Engineer guides validation protocol development and execution, reviews final reports for acceptance, and leads or participates in product and process improvement projects. Additional duties include reviewing and approving manufacturing procedures, test method validations, quality inspection plans and process run sheets; conducting internal and process audits and supporting vendor, FDA and Notified Body audits; reviewing customer product specifications and initiating or reviewing engineering change notices; certifying new production operators in QA training; and supporting product improvements through quality planning, risk evaluation and validation. Other QA duties may be assigned by the QA Manager. Hybrid or remote work options are being considered, and expected travel is up to 10%.

Requirements

At least 3 years of Quality Assurance experience.
Manufacturing experience.
Strong communication and presentation skills.
Demonstrated experience or success with CAPA and nonconformance processes.
Demonstrated experience or success with customer complaint investigations.
Demonstrated experience or success with validation concepts and techniques, including process, equipment and test methods.
Demonstrated experience or success with continuous improvement and project management.
Demonstrated experience or success with process and/or internal auditing.
Knowledge of QSR, CFR, cGMP and ISO regulations.
Proficiency with Microsoft Word, Excel and PowerPoint.
Strong problem-solving skills and experience with root cause analysis tools, such as 6M, Cause-and-Effect and 5 Whys.
Strong verbal, written and listening skills.
Strong interpersonal skills and ability to work effectively in a team environment.
Ability to prioritize and adapt to changing priorities.
Ability to work independently with limited supervision.

Nice To Haves

Bachelor’s degree, unless equivalent ASQ Certified Quality Engineer certification is held.
Regulated or medical industry experience.
Experience with Minitab and SAP ERP.
Knowledge of statistical techniques such as DOE, SPC and Gage R&R.
ASQ Certified Quality Auditor certification.
Design Control and Risk Management experience.

Responsibilities

Lead Quality activities for Conductor Material Review Board coordination, inspection methods, nonconformance containment, correction and closure, and CAPAs; analyze trend data and drive improvements.
Lead Conductor customer complaint investigations, confirmation and corrective actions; serve as the primary customer contact for complaint communications and drive improvements based on trends.
Guide and review validation protocol development and execution, and review final reports for acceptance.
Lead and participate in short-term product and process improvement projects.
Review, revise and approve manufacturing procedures, test method validations, quality inspection plans and process run sheets.
Perform internal and process audits, participate in vendor audits as needed, and support back-room activities during FDA and Notified Body audits.
Review customer product specifications; initiate Engineering Change Notices and review or approve changes as needed.
Conduct QA training certifications for new production operators.
Support product improvements through quality planning, risk evaluation and validation.
Perform additional QA responsibilities as assigned by the QA Manager.