Cepheid MSc Biotech, Biochem Quality Specialist Job Opening, Apply Online
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Hey there, looking for assistance with the possible interview questions and answers for the role of Commercial Quality Specialist at Cepheid, then check them out below
Commercial Quality Specialist
Site: Gurugram, Haryana, India
Job ID: R1239048
Job Title: Commercial Quality Specialist
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change
on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.Learn about the Danaher Business System which makes everything possible.
- Responsible for general support and maintenance of the Quality System/Regulatory Compliance within the requirements of the international and national standards such as the QSR, ISO 13485, 98/79/CE Directive for IVD including;
- the document control system, corrective and preventive action system, internal audits and administrative support
- Material quality assurance, batch record issuance, management of the quality documentation.
- Field Safety Corrective Action and Reporting the Adverse Events Report to the competent authorities.
- Ensure compliance as per MDR 2017, European regulations, ISO 9001, ISO 13485, Cepheid corporate quality system requirements.
In this role, you will have the opportunity to:
- Review records and documents, for completeness and compliance with MDR and ISO requirements.
- Review batch record to support release of incoming goods received in quarantine status and final and refurbished products (Gx modules at repair center).
- Support compliance to post market surveillance process; Field Actions, Complaint Handling (Safety and Quality Complaints) & Logistic & Distribution as per law of land of India.
- Support of document control system facilitating document creation and approvals.
- Assist with the implementation of standard operating procedures to define and improve quality system functions.
- Support interdepartmental initiatives for continuous improvement.
- Partner with departments to promote improvements, through the use of training.
- Support the corrective action program in the investigation and resolution of issues.
- Support the electronic documentation process, as needed.
- Participate in the internal auditor program, as needed
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
The essential requirements of the job include:
Education and Experience:
- Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical field
- 2-4 years of experience in the medical devices industry (IVD can be a plus)
- Experience within commercial quality is very beneficial and highly desirable
- Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
Knowledge and skills:
- Excellent verbal and written communication skills
- Knowledge of International Organization for Standardization ISO13485
- Knowledge of International regulations QSR for USA, CE Directive and Regulation for India.
- Excellent planning and organizing skill
- Exceptionally strong team player with excellent interpersonal and communication skills
- Able to confidently deal with ambiguous issues and provide input towards suitable actions.
It would be a plus if you also possess previous experience in:
- Experience working with medical device quality systems in compliance with MDR and ISO 13485
- Able to interpret quality problem and establish practical solutions within a dynamic business environment.
- Experience in leading continuous improvement efforts, in both quality systems and products.
- Knowledge of the process of establishing facility QMS certifications.
- Cross functional experience with products and commercial operations processes to influence change at all levels within the organizationVisio and Project knowledge desirable.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Hey there, looking for assistance with the possible interview questions and answers for the role of Commercial Quality Specialist at Cepheid, then check them out below
- Can you explain the key regulatory standards and requirements (such as QSR, ISO 13485, 98/79/CE Directive for IVD) that are relevant to the medical devices industry, and how they impact quality and regulatory compliance? Answer: The QSR (Quality System Regulation), ISO 13485, and 98/79/CE Directive for IVD are crucial regulatory standards in the medical devices industry. These standards outline requirements for quality systems, product development, document control, corrective and preventive actions, internal audits, and material quality assurance. Compliance with these standards ensures the safety and effectiveness of medical devices and adherence to international regulations.
- How would you ensure compliance with MDR 2017 (Medical Device Regulation 2017) and other relevant regulations while maintaining a commercial quality system? Answer: Compliance with MDR 2017, European regulations, ISO 9001, ISO 13485, and Cepheid’s corporate quality system requirements is essential. I would review records and documents for completeness and compliance, implement standard operating procedures, support post-market surveillance processes, facilitate document control, assist with corrective actions, and participate in internal audits. Additionally, I would stay updated with regulatory changes and ensure the necessary adjustments are made to maintain compliance.
- How would you contribute to continuous improvement initiatives within the quality system? Can you provide an example of a quality improvement project you led or participated in? Answer: I believe in constantly improving quality systems and processes. I would actively participate in interdepartmental initiatives, collaborate with teams to identify areas for improvement, and propose practical solutions. For example, in my previous role, I led a project to streamline complaint handling processes, resulting in reduced response times and improved customer satisfaction.
- How do you stay updated with changes and advancements in quality and regulatory standards? Can you provide examples of how you have applied new knowledge or regulations in your previous work? Answer: I stay updated with changes in quality and regulatory standards by regularly reviewing industry publications, attending relevant seminars and conferences, and actively participating in professional networks. In my previous role, I successfully implemented the updated ISO 13485:2016 standard by conducting gap assessments, revising quality procedures, and training staff on the new requirements.
- How do you effectively communicate and collaborate with cross-functional teams to drive quality improvements? Can you provide an example of a situation where you influenced change at different levels within an organization? Answer: Effective communication and collaboration are crucial for driving quality improvements. I ensure open and transparent communication, actively listen to stakeholders’ perspectives, and align goals and objectives. For example, in a previous project, I collaborated with R&D, manufacturing, and commercial teams to introduce a standardized quality control process, resulting in reduced product defects and improved customer satisfaction. I facilitated cross-functional meetings, provided training, and gained buy-in from all levels of the organization to achieve successful implementation.
Note: Answers should be tailored based on the candidate’s actual experience and knowledge.
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