Job Information
ThermoFisher Scientific Manager, Product Compliance Laboratory in Hyderabad, India
Work Schedule
Other
Environmental Conditions
Office
Job Description
About company:
Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global teams of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com
About team:
Providing outstanding product development services to Thermo Fisher scientific global business units, is one of the critical functions of the India Engineering Center (IEC). This global research and development center, established in 2009, located at HiTech City, Hyderabad, with over 150 employees. We are a team committed to develop innovative and groundbreaking technologically sophisticated products ranging from laboratory equipment, analytical instruments, remote monitoring solutions, chromatography and mass spectrometry. We are proud of the work that we do at IEC thereby fulfilling our mission of making the world a healthier, cleaner, and safer place:
About the Job:
Ideal candidate will help bring ownership for a design de-risking of PCBA which may need refresh driven by aging design or supply chain issues. In the position, candidate will work closely with global sites to ensure that Change management within this portfolio achieves an excellence. Will ensure right design metrics are followed.
Role Purpose Summary:
The "Manager, Product Compliance Laboratory" is a professional level member of a global R&D Team. The role is of a hands-on Electrical/Electronic engineer who is motivated & technically proficient on understanding new designs and update of existing products. The person will play key role in demonstrating engineering knowledge to assist team in its PCBA Risk Mitigation strategy.
Location/Division Specific Information
Hyderabad / Thermo Fisher Compliance Lab
Responsibility:
Responsible for the coordination and implementation of testing and validation strategy and compliance programs through the review, consultation, training, and support of each domain (Engineering, Operations, Quality, Sales, Sourcing, etc.) to fulfill their business goals with the most technical compliance.
Responsible for interacting with Cross Functional Team (CFT) network of people and resources in the business unit and provide general regulatory testing support in the regions and time zones where BU facilities operate, also, provide additional review and consultation for regulatory needs from centers of compliance excellence.
Responsible for providing regulatory assistance in implementing New and Existing Product Development projects (medium complexity level), supervise and handle timelines that are in test lab’s control, and provide a regular update to project collaborators.
Collaborate closely between the respective domains and 3rd Party regulatory agencies (UL, CSA, TUV, etc.) and ensures this interaction follows the established Standard Operating Procedures for the division.
Responsible for review and sign off of testing and validation reports prepared by lab staff .
Maintaining the test Laboratory with National level Accreditation Quality management system procedure in accordance with NABL ISO/IEC 17025:2017 Quality system. Also, as per A2LA and iLAC MRA accreditations.
Ensure all testing activities for the project are performed conforming to the standard requirements.
Participating Internal and External Audits as per lab Quality Management System (QMS) policy.
Assist in departmental SOP development and adhere to Quality Management System requirements
Participates in risk-benefit analysis for regulatory compliance
Act as a change agent for improvement initiatives and facilitate finding a better way every day
Perform all job duties in a safe manner and obey all safety policies and procedure
Act in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement, and Innovation)
Qualification
Graduate degree in Science or Engineering
Deep knowledge with 10+ years in EMC testing of Laboratory products / medical device or similar regulated industry
Shall have a strong experience of about 7yrs in testing and validation requirements of product, processes, and procedures.
Experience in product compliance or product stewardship 3-5 years either in industry or at a Nationally Recognized Test Lab
Strong understanding of the applicable product safety standards and how to apply them effectively
Detailed understanding of IEC/EN 61326-1, IEC/EN 60601-1-2, CISPR 11, FCC part 15 ICES-001 and other basic EMI / EMC standards.
Knowledge on using RF instruments such as signal generators, RF amplifiers, spectrum analyzers, EMI receiver, antennas, probes, ESD equipment, CDN, etc.,
Knowledge on ISO/IEC 17025:2017 accreditation procedure and documentation.
Knowledge on iLAC MRA and A2LA accreditation would be added advantage.
Sound knowledge on Measurement uncertaininty calculation
Hands-on experience in participating audits in accordance with ISO/IEC 17025
Skills, Knowledge and Experience
Able to work independently without supervision
Able to communicate effectively, written, and oral, with both technical and non-technical colleagues.
Self-Motivator, Does not accept “waiting for a response”. Must work with respective stakeholders to acquire the vital information and drive a project forward
Must be a Problem Solver; Identifies problems and reviews related information to develop and evaluate options and implement solutions.
Able to lead parallel projects and sometimes opposing priorities to meet project delivery dates.
A team player willing to support and guide peers in analyzing and solving challenges
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exiting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.