Staff Quality Engineer

**Who We Are**

**Purpose**:
You are responsible and accountable for assisting the Quality Engineering, Regulatory Compliance and Quality Laboratory elements and activities for the manufacture of BACTEC Media products and the shipment of products from the facility. This role reports to the Quality Manager.

**Responsibilities**:
Quality Engineering
- Manages and mentors a team of Validation, Product and Process and/or Laboratory Quality Engineers in maintaining an effective and compliant Quality System, driving Quality objectives/ initiatives and dispositions raw materials and products according to specifications.
- Lead plant wide validation program which including engineering study and changes assessment ensuring compliance to Corporate Policies and Regulatory/ Compliance standards.
- Leads and participates in issues requirements for new products transfer, existing products with significant changes, product or process improvement teams across functions to ensure compliance to internal and external requirements.
- Responsible in risk management activities ensuring that Product Risk Analysis files are updated when applicable.
- Manage supplier quality management activities ensuring supplier compliance and capability for Qualification, Approval, Monitoring, and CI activities and facilitates and partners with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration.
- Developing Quality Inspection plans for In-coming, In-Process, and Out-going Inspection ensuring that they are Statistical based.
- Manages and monitors the non-conformance investigation and improvement opportunities (to increase compliance, reduce costs, etc.) in quality system and implements or recommends solutions. Provides proactive guidance and advice to ensure that new or changed systems meet procedural and regulatory requirements.
- Manages and monitors a risk based Corrective and Preventive Action system ensuring nonconformances are documented, investigated, and corrected or with correction actions to prevent recurrence.
- Supports activities relating to Field Corrective Actions, Adverse Events, Situational Analysis as and when needed.

Regulatory Compliance
- Support the implementation of an approved auditing plan in accordance with QSR and ISO 13485 and/or similar regulations.
- Initiates changes to current practice and procedures to support compliance requirements. Communicates and brings regulatory compliance questions/ issues to the attention of the impacted functons.
- Establishes audit corrective action teams as needed. Monitors and reports corrective action progress.
- Periodically reports regulatory risk assessment and corrective action progress to management to mitigate risks.
- Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Ensures that required documents are filed with appropriate agencies.

Quality Laboratory
- Support establishing and directing laboratory activities for Label Control, Quality Testing of raw materials, WIP and finished products as to assure only release products that are safe, effective and perform as intended.
- Support developing of testing procedures to maintain comprehensive, maintain comprehensive, cost-effective and progressive Quality Standards for all plant products.
- Support and/or approves decisions regarding release, retest and /or discrepancies of product based on accurate interpretation of test results and investigations (OOS) coupled with technical knowledge.

**Our Requirements**:

- Bachelor's Degree in Microbiology, Biology Medical Technology, Chemistry, Engineering and/or commensurate experience combined with minimum 2 years’ of Supervisory/People Management experience.
- Minimum 5 years’ experience specifically in Process, Equipment and/or Software Validation in medical devices, pharmaceutical or life science industry.
- Strong background in process analysis, problem solving skills, and improvement using process flow and/or Lean Manufacturing method.
- Knowledge and understanding of Process / Equipment Validation, Risk Analysis / FMEAs, FDA, and other regulatory requirements for medical devices and the demonstrated ability to interpret and communicate these requirements.
- Excellent interpersonal, organizational, planning, prioritization, team building, and communication (written and verbal in English) skills.
- Experience in the use of SAP, Minitab, and Quality Systems Software (e.g. Trackwise).
- Added advantage with knowledge of Project Management, Statistics and Data Analysis to drive data based results, or Six Sigma Green Belt certified.

**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 emb