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156 Thermo Fisher Scientific Jobs
Manager, Compliance
Thermo Fisher Scientific
posted 5d ago
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Flexible timing
Key skills for the job
Job Description
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 stakeholders.
- 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)
- 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
- Solid 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 uncertainty calculation
- Hands-on experience in participating audits in accordance with ISO/IEC 17025
- 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 collaborators to acquire the critical 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 great lead willing to support and guide peers in analyzing and solving challenges
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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