Quality Engineer 2

Teleflex • GA

67d

About The Position

This position provides Quality Engineering leadership to Conductor manufacturing as the lead Quality member on the team. The primary purposes and objectives include: Nonconformance and CAPA coordination and processing; Customer complaint investigations; Process & product validations; Customer Notification of Change evaluations; Internal & external auditing responsibilities and support; Quality improvement projects; and Maintain compliance with applicable Teleflex Global & local Procedures and Policies.

Requirements

• Excellent communication and presentation skills.
• Bachelor degree is preferred or the equivalent ASQ Certified Quality Engineer certification.
• 3+ years of Quality Assurance experience required.
• Experience in a manufacturing environment, with preference in a regulated or medical industry.
• Experience and proven success in CAPA and Nonconformance process.
• Experience in Customer Complaint Investigations.
• Knowledge of validation concepts & techniques (process, equipment, and test methods).
• Experience in Continuous Improvement Process/Project Management.
• Experience in process or internal auditing.

Nice To Haves

• Knowledge of QSR, CFR, cGMP, and ISO regulations.
• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint.
• Experience with Minitab and SAP ERP.
• Statistical Techniques (DOE, SPC, Gage R&R).
• Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc).
• Good listening, verbal and written communication skills.
• Excellent interpersonal skills with a demonstrated ability to work in a team environment.
• Ability to prioritize and adapt to shifting priorities.
• Ability to work independently with limited supervision.
• ASQ Certified Quality Auditor highly desired.
• Design Control and Risk Management experience desired.

Responsibilities

• Lead quality activities with respect to Conductor Material Review Board coordination; inspection methods, NC containment/correction/closure and CAPAs; and drive improvement through analysis of trend data.
• Primary investigator and facilitator for Conductor complaint investigation, confirmation and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends.
• Guide and review protocol development, validation implementation and report review and acceptance.
• Lead and participate on key short-term projects on product or process improvements.
• Review, change and approve Manufacturing Procedures; Test Method validations; Quality Inspection Plans and Process run sheets.
• Routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Back Room during FDA and Notified Body audits.
• Perform Customer Product Specification reviews. Initiate Engineering Change Notices and review/approve as needed.
• Perform QA training certifications on new Production operators.
• Support Engineering with improving Product with quality planning, risk evaluation and validation.
• Perform any additional QA tasks, as assigned by QA Manager.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees