Quality Engineer II

Position Summary

The Quality Engineer will provide support for Quality and Operations, interact with cross-functional team members and internal customers and provide support for Engineering, Quality Systems, Projects and Process engineering.

Specific activities may include but are not limited to:

• Nonconformance and CAPA coordination and processing;
• Service complaint investigations;
• Process & product validations;
• Customer Notification of Change evaluations;
• Internal & external auditing
• Front room and back-room audit support;
• Statistical analysis
• Quality and continuous improvement projects
• Assure compliance with applicable Teleflex Global & local Procedures and Policies

Principal Responsibilities

• Nonconformance (NC) and CAPA processing – independently 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. Ability to resolve non-conformances.
• Serve as CAPA Champion as needed: Coach and support CAPA Owners to ensure compliance; monitor weekly reports to act on upcoming due dates; run CRB meetings (record minutes, track actions, escalate to ECRB, and archive records); and train new CAPA Owners. Serve as CAPA Owners and Phase Owners as assigned.
• Service 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.
• Strong understanding of Supplier Quality activities including supplier onboarding, supplier evaluation, supplier performance monitoring, supplier corrective actions (SCAR). Can recognize and resolve nonconformances within the system.
• Process Validations – guide and review protocol development, validation implementation and report review an acceptance;
• Quality & Cost Improvement Projects – lead and participate on key projects for product or process improvements;
• Maintain company compliance with Quality System Regulations and ISO 13485 standards.
• Experience with FDA and ISO inspections and registration. Able to interpret general audit requests to identify relevant SOPs, records, etc.
• Documentation Control – perform Product Specification reviews. Compiles and writes procedures, work instructions, training material, and conducts training sessions on QMS & Quality assurance activities.
• Manage and lead implementation of continuous improvement projects
• Manage, lead and provide Project Management support as needed.
• Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
• Ability to use statistical techniques to make recommendations for standard sampling plans/sample size determinations, to support inspection processes (e.g. AQL) and statistical-based product testing (verifications or validations).
• Understand use of statistical techniques that can identify trends within product/process capabilities and quality system metrics.
• Knowledge of critical process control, identification of inspection steps, creation of disposition requirements, identification of CTQs (critical to quality inputs and outputs), identification of critical to function, Statistical Process Control (SPC).
• Knowledge of measurement methods and tooling or equipment used. Able to execute more complex measurement-related tasks, such as tensile testing, burst testing, etc.
• Ability to establish testing methods based on applicable standards.
• Able to identify nonconformities related to the measurement process and participate in the resolution of these nonconformities.
• Aware of the necessity of test method validations for defined processes, able to run MSA or R&R studies.
• Ability to use a range of problem-solving tools.
• Ability to apply lean principles.
• Perform any additional QA tasks, as assigned by the QA Manager.

Education / Experience Requirements

• Excellent communication and presentation skills.
• 3+ years of Quality Assurance experience required within the medical device / FDA regulated industry preferred.
• Bachelor's degree in engineering
• Knowledge of Quality Systems Requirements (ISO 13485, CFR 820).
• Project Management experience, preferred.
• Experience with SAP applications (desirable)
• Manufacturing or distribution experience preferred.
• Quality certification a plus (e.g., CQE, CRE, CQM, Six Sigma, etc.).
• Relevant Experience working within the medical device, Pharmaceutical, or other FDA-regulated Industry is an advantage.

Specialized Skills / Other Requirements

• Quality Assurance in a Medical Device Environment (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience highly preferred
• Experience with Corrective Action, Manufacturing and Design Control concepts desired.
• Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.).
• Positive attitude and ability to operate and communicate effectively with multiple teams & leadership.
• Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change.
• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
• 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

TRAVEL REQUIRED: 10%

#LI-LM1