Quality Engineer

Position Summary

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

Principal Responsibilities

Nonconformance (NC) and CAPA processing – 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.
• Customer Complaint Investigations – 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.
• Process Validations – guide and review protocol development, validation implementation and report review an acceptance;
• Quality & Cost Improvement Projects – lead and participate on key short term projects on product or process improvements;
• Production & Process Controls – review, change and approve Manufacturing Procedures; Test Method validations; Quality Inspection Plans and Process run sheets
• Auditing – routinely perform internal and process related audits. Participate in vendor audits if necessary. Support the Back Room during FDA and Notified Body audits.
• Documentation Control – perform Customer Product Specification reviews. Initiate Engineering Change Notices and review/approve as needed.
• Training – 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.

Education / Experience Requirements

• Bachelor's degree is preferred or the equivalent ASQ Certified Quality Engineer certification.
• 5+ years of Quality Assurance experience required.
• Experience in a manufacturing environment, with a preference in a regulated or medical industry.

Additional experience and proven success in the following area or skill:
• CAPA and Nonconformance process
• Customer Complaint Investigations
• Validation concepts & techniques (process, equipment, and test methods)
• Continuous Improvement Process/Project Management
• Process or internal auditing.

Specialized Skills / Other Requirements

• Knowledge of QSR, CFR, cGMP, and ISO regulations (required)
• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
• Experience with Minitab and SAP ERP is desired.
• Statistical Techniques desired (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 is desired
• Ability to work independently with limited supervision
• ASQ Certified Quality Auditor highly desired
• Design Control and Risk Management experience desired.

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