Quality Engineer

**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.

**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.
- 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.
- 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.
- Set up and responsible for the quality inspection plan including adequate controls are adequate and supporting documentation are available.
- Lead or participate in Risk Management activities appropriate to the initiative or situation.
- Lead the disposition of raw materials, in-process samples (where applicable) and final products regardless of product load demands. Lead the documentation of Rework and/ or Special Inspections where applicable.
- Perform routinely functions in the SAP System for regular maintenance of the QM module.
- Develops, implements and audits approval systems
- Develops, implements, and audits Label Control systems and procedures
- Performs other duties as requested by Facilitator.

**Our Requirements**:

- Bachelor's Degree or equivalent in Microbiology, Biology Medical Technology with courses in Chemistry, Engineering or commensurate experience combined with specialized courses.
- Three (3) to five (5) years experience in an industrial QA environment (such as general laboratory experience, Complaint handling, Change Control handling, Non-conforming handling, Supplier Management and/or Labeling Control) in medical devices, pharmaceutical or life science industry. Added advantage with working knowledge of current QSR's, ISO, and ANVISA standards.
- Experience in SAP, Minitab, and Quality Systems Software (e.g. Trackwise)

**Culture and Benefits**

Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.

**How To Apply