Quality Engineer

Job Description Summary

The Quality Engineer - Product & Process reports to the Quality Manager for the responsible and accountable of quality engineering/ label control/ assurance elements and activities supporting Operations including supply supplier. Has the responsibility of developing test instrumentation and procedures to maintain comprehensive, cost-effective and progressive Quality Standards for all plant products.

Ensuring that Quality Master Data is available, accurate and meets compliance requirements. Has the responsibility to maintain Quality Notifications and Deviation in SAP.

The QE will initiate and drive partnership, and collaborate with stakeholders, customers, and suppliers to support and execute Operation, Quality, and Regulatory Key Business objectives and Strategies for the Manufacturing site. The QE will also work with key functional groups for problem solving to improve processes. Focus on Performance/Metrics data for and drive value add quality initiatives for continuous improvements.

The QE will also work with external Regulatory and Compliance agencies ensuring timely and accurate submissions to respective requirements.

The QE is the technical liaison for all quality related aspects of supplier management including supplier approvals, qualifications, assessments and SCAR/CI activities. In addition, the QE/SQE will partner with Operations, Design, and Procurement groups to execute and monitor Supplier Management processes and strategies, and drive partnership and collaboration with the supply base.

**Job Description**:
Who We Are

Job Purpose:
The Quality Engineer - Product & Process reports to the Quality Manager for the responsible and accountable of quality engineering/ label control/ assurance elements and activities supporting Operations including supply supplier. Has the responsibility of developing test instrumentation and procedures to maintain comprehensive, cost-effective and progressive Quality Standards for all plant products.

Job Responsibilities:
- Responsible for driving and executing Quality Engineering Sustaining Activities including Process Monitoring/ Evaluations, CI Improvements, Metric Reporting, Data Analysis, Control Plans, and Change Control.- Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Procurement, Engineering, and Regulatory.- Support Product Transfers and Scale Up from Innovation sites ensuring a timely and successful launch meeting all requirements and responsible for the quality and regulatory element in the Product Transfer process.- Develops test methodologies, designs test data forms and writes standard test methods in support of new product lines, product line specials or product line extensions.- Leads Supplier Capability Assessments ensuring suppliers are fully capable in meeting BD’s requirements.- Provides quality support for Supplier Qualification and Approval Process and are completed adequately including areas in quality planning, risk assessments, critical to quality characteristics, supplier spec., validations, verifications, quality agreements and control plans.- Facilitates and partners with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration.- Support Change Review Board process authorizing / approving all changes (including Supplier Process Changes) following established guidelines.- Initiates changes to existing practice and procedures to support compliance requirements. Communicates the need for compliance to members to all functional areas.- Reviews and supports product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.- Leads cross functional teams for quality initiatives project for continuous improvements as per Quality tools such as Design of Experiments, Statistical/ Data Analysis, and MSA/ Correlation.- Ensures Quality Assurance and Regulatory Compliance Systems are aligned with BD, Regulatory and Industry standard requirements.- Responsible for supporting and closing of Quality Notification, Deviation and Customer Complaints in a timely manner ensuring regulatory requirements are met; to manages and Investigates non-conforming materials and products for root causes (to regulations or procedures) and improvement opportunities (to increase compliance, reduce costs, etc.).- Executes, and monitors a risk based Corrective and Preventive Action system ensuring nonconformance are documented, investigated, and corrected or with correction actions to prevent recurrence.- Leads and Supports activities relating to Field Corrective Actions, Adverse Events, Situational Analysis when needed.- Set up and responsible for the quality inspection plan including adequate controls are adequate and supporting documentation are available.- Support and executes associate training for QSR training pr