| Company: | BD |
|---|---|
| Job Role: | Staff Quality Engineer. |
| Experience: | (2-3 years). |
| Vacancy: | 28+ |
| Qualification: | BS Degree in Engineering or related skills. |
| Salary: | S$ 95,499/year. |
| Location: | Singapore. |
| Join us on Telegram | Click Here |
| Apply Mode: | (Online) |
| Deadline: | Not Mentioned |
By improving medical discovery, diagnostics, and delivery of care, BD is one of the world's largest global medical technology companies. As a provider of innovative technology, services and solutions that support the heroes on the frontlines of health care, the company contributes to both clinical therapy for patients and the development of clinical processes for health care providers. Aside from helping to improve the quality of care for patients, BD also strives to help make clinicians' work more efficient and safe, help laboratory scientists diagnose disease better, and empower researchers by allowing them to develop the next generation of diagnostics and therapeutics. BD is present in virtually all countries around the globe and partners with organizations to help address some of the most challenging global health issues. We work together with our customers to increase access to health care, lower costs, improve efficiencies, increase safety, and improve outcomes. C. Has been with BD since 2017. A new product line by R. Bard has been added to the BD family. Medical discovery, diagnostics, and healthcare delivery are BD's main priorities. Approximately 65,000 employees worldwide contribute to the advancement of patient care.
Job Description Summary
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.
Job Description
Who We Are
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.
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.
Job 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 non conformances 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 functions.
- 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 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 Click on the Below link, it will redirect you to source Page and apply there.
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