Sr Norm Compliance Officer jobs at Philips in India, Pune

Work on achieving a state of high quality performance at our Supplier partners. You will pursue continuous quality improvement through the application of Quality Engineering practices on Philipsproducts/parts/services

You are responsible for

• Reviewing Supplier Quality Agreements
• Analyze defects to determine if they are supplier caused and notify accordingly
• Managing/Issuing/Following up on Supplier Corrective Action Requests
• APQP execution, monitoring and control as part of Sustaining Changes (Life Cycle Engineering)
• Supplier performance monitoring, reporting, improvement and development
• Support Supplier quality risk assessment and mitigation
• Acceptance of products that have gone through NPI process before official release
• Support Supplier audit schedule development and maintenance for audits related to supplier processes, supplier selection,corrective/preventiveaction verification
• Assess and coordinate Supplier Change Requests
• DEFOA analysis and securing reoccurrence

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in Electrical/Electronic/Mechanical Engineering (Prefer E&E) or other scientific field, or equivalent experience
• Minimum 10+ years’ experience in supplier quality in a highly regulated industry (PCB/Coils experience is a must, having IPC standard knowledge is added advantage)
• Detailed knowledge and experience of APQP and related PPAP tools
• Well versed in Quality Engineering and Continuous Improvement techniques
• Participated in several NPIs from start to finish
• Direct shop-floor production engineering sustaining experience
• Strong negotiation skills and ability to lead through influence
• Experience having direct working relationships with suppliers
• Flexible mindset and proactive approach
• Excellent communication skills in English
• Willingness to travel up to 20% of the time

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

• A market conform salary
• 25 Days of leave and the possibility to purchase up to 20 extra days off annually
• A variable bonus based on both Philips results and personal performance
• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
• Solid company pension scheme and attractive collective health insurance package
• Opportunity to buy Philips shares and products with discount
• Healthy work-life balance

Your role:

• Defining, for products to be developed, the applicable safety standards and regulations such as IEC 60601 series and/or IEC 62304, IEC 62366, the new EU MDR, and Particular Standards IEC60601-2-37, and in particular EMI/EMC IEC 60601-1-2 standards and testing
• Defining within the Standards and Compliance plan how the required standards and regulations will be covered in evidence for demonstrating compliance
• Review standard updates and deploy revised standards. Identification of approbation consequences due to change requests. (Notified Body Audits)
• The project deliverables related to Norm Compliance responsibilities
• Securing the implementation and verification of all specified legal requirements by reviewing these related project deliverables
• Supporting designers and testers with the interpretation and testing of standards and regulations concerning the technical design of Ultrasound products. Input to design reliability, Electrical or Mechanical
• Arranging and completing all evidence for gaining product certification by the independent certifying agency
• Providing the Regulatory Affairs department with technical support for the preparation of submissions to Regulatory bodies and countries
• Own norm compliance portfolio for Ultrasound products and execute end-to-end activities according to regulations.
• Work on the project deliverables related to Norm Compliance release evidence – Generate Technical File for CSA, MDD & MRDR certification
• Definition of product requirements to assure norm-compliance
• Decomposition towards the individual (sub)system elements
• Support concerning the technical realization/engineering of norm compliance of the (sub) system.
• Support the verification (testing, witnessing, and reporting) and approval of all specified legal requirements.
• Supervise audits and witness testing performed with CSA personnel
• Maintain the current Philips Ultrasound certification program with CSA, as well as all business and working relationships with CSA.
• Be the intermediary between development and certifying/regulatory agencies (UL/CSA/FDA/BSI, etc).
• Train and inculcate design and cross-functional teams on regulatory standards, updates, and execution.

You're the right fit if:(4 x bullets max)

• B.Tech/ME/MTech in Bio-medical/Electrical/Electronics with 10+ years of experience, preferably in the Medical domain
• Knowledge and Experience of relevant regulations (UL, CSA, IEC, ISO, MDD, CE, etc.) and relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.)
• 5-6 years of work experience with product safety testing and EMI/EMC analysis
• Knowledge of IEC 60601 standards, risk management, verification, and validation of medical devices
• Know-how of design control processes for medical device design
• Knowledge of project organization, PCP, and ISO 13485 is preferred
• Good team player and ability to work independently & act proactively
• Analytical, creative, and abstract thinker
• Ability to communicate (both written and verbal) on different levels
• Is capable of introducing efficiency improvements on the project level (change management)
• System thinking mindset and domain expertise in the related area
• Fast learner and interested to learn new technologies/business/systems
• Be structured and self-organized
• Excellent communication skills
• Team player, leadership skills, and drive for results
• Mindset to simplify and reach solutions with speed
• Intercultural sensitivity

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Sr Norm Compliance Officer

As a multi-business modality hub, HIC innovates across product lines, including Image-Guided Therapy (IGT), Precision Diagnosis, and Connected Care. Teams of R&D, design, software developers, mechatronics & product marketing work together to build a product starting from market requirement understanding until delivery. Products innovated and manufactured at HIC are launched/ shipped in both Indian and global markets.

Your role:

In this role, you have the opportunity tosupport the Norm Compliance activity for IGT-MoS products with all relevant mandatory international and national regulations including MDD & MDR and Philips Healthcare processes.

• Own norm compliance portfolio for IGT MoS products and execute end to end activities in accordance with regulations.
• Work on the project deliverables related to Norm Compliance release evidence –Generate Technical File for MDD & MRDR certification.
• Identification of relevant clauses from standards for (sub)system,Standards mainly includes IEC60601-1, IEC60601-1-2, IEC60601-1-3 etc.
• Definition of product requirements to assure norm-compliance.
• Decomposition towards the individual (sub)system elements.
• Secure the implementation and verification of all specified legal requirements.
• Support with respect to technicalrealization/engineeringof norm compliance of the (sub) system.
• Support the verification (testing, witnessing and reporting and approval) of all specified legal requirements.
• Be the intermediary between development andcertifying/regulatoryagencies (UL/CSA/FDA/BSIetc).
• Test lab interaction experience.
• Support arrangements for and completion of submission to certifying agencies.
• Review standard updates and deploy revised standards.
• Identification of approbation consequences due to change requests. (Notified Body Audits)
• Train and inculcate design and cross functional teams on regulatory standards, update and execution.
• Contributing to Technology Roadmaps
• Build norm compliance team and coach them on various activities with the portfolio

You're the right fit if:

• B Tech / M.Tech/ME in bio-medical engineering having IQ specialization with ~12+ years of experience withminimum 5 years of experience in the X-ray system/subsystem design & development (or at least two end to end X-ray product development)
• In depth understanding of system wide IQ, combining IQ related theory (e.g. x-ray physics, image processing, visual perception, etc.) with understanding of relevant products and the application by the end-user.
• Knowledge of relevant regulations (UL, CSA, IEC, ISO, MDD, CE, etc.) and relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.).
• Knowledge on project organization, PCP and ISO 13485.
• Knowledge of IEC 60601 standards, risk management, verification and validation of medical devices
• Knowhow of design control processes for medical device design
• Working knowledge of cabling design, design for EMI/EMC, Design for reliability
• Good team player and ability to work independently & act pro-actively.
• Analytical, creative and abstract thinker.
• Ability to communicate (both written and verbal) on different levels.
• Is capable to introduce efficiency improvements on project level (change management).
• System thinking mindset and domain expertise in the related area
• Fast learner and interest to learn new technologies/business/systems
• Be structured and self-organized
• Excellent communication skills
• Team player, leadership skills and drive for results
• Mindset to simplify and reach to solutions with speed
• Intercultural sensitivity
• Self-motivation

How we work together

This role is an office-based role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .

You will sustain and maintain labeling system software, hardware and processes in a medical device manufacturing environment.

Your role:

• Develop and maintain a complete labeling system (software, processes and equipment) for complex medical devices.

• You are responsible for: the development sustaining of a complete labeling system solution software; the quality and compliance of medical device labeling; internal and external database management; validation activities (software and hardware); and departmental work instructions/processes.

• Deployment and administration of a complete labeling system, including documented Work Instructions (WIs) and departmental Standard Operating Procedures (SOPs).

• Ensuring timely change management of labeling and Instructions For Use (IFUs), working with labeling technicians/label coordinators, and performing labeling changes.

• Quality management and all life-cycle phases of product labeling and IFUs. Leadership, both direct and indirect, will be an expectation of this role as a growth path.

You're the right fit if:

• You’ve acquired 1+ year of engineering experience in medical device or other highly regulated industry.
  Your skills include supporting quality related investigations and changes involving labeling materials and/or labeling processes, such as NCRs, CAPA, SICRs, IIAs, Audit Support questions, Equipment Events, Regulatory Gap Assessments, etc.

• You have a B.S. in Engineering.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You’re an excellent communicator that is detail oriented and well organized.

How we work together:

This is an office-based role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .

• Discover

• Learn more about

• Learn more about

The pay range for this position in CO is $71,250 to $114,000

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN .

Your role:

• Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations.
• Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual system or sub-systems.
• Preparation of norm compliance test plan that include applicable relevant clauses from standards (standards mainly include IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-2-54, ISO 10993 etc.).
• Support in risk assessment related to product safety for achieving mitigation.
• Support usability and software teams to deliver documentation required for certification
• Support design and procurement team to ensure third party component level compliance
• Execute testing (witnessing, reporting and approval) of all specified product safety requirements.
• Arrangements of DXR product and required documents to test/certification agencies (like TUV/CSA/Any other lab) as part of submission and completion of certification activities.
• Support in preparing technical file deliverables (like GSPR and Compliance Data Record) in support to MDD, MDR, RED, REACH, RoHS regulations.
• Achieve certification of DXR products with all relevant global standards and regulations.
• Ensure timely delivery of all approbation activities / documentation adhering to Philips processes.
• Support the Regulatory team to achieve all regulatory approvals.
• Support all audits (FDA, Notified Body, INMETRO, etc).
• Review standard updates and provide standards gap assessment / technical support to the Regulatory team.
• Provide Training and guide all cross-functional teams on regulatory standards, update and execution.
• Maintain DXR compliance lab and its qualifications with CSA & Intertek as per ISO17025.
• Identification of approbation consequences due to change requests.
• Support factory inspections by certification agencies and address all audit observations in a timely manner (if applicable).
• Keep abreast of future upcoming regulatory & standards by interacting with notified body and standard organizations.

You're the right fit if:

• BE, BTech, ME, MTech degree (preferably in Biomedical/ Electrical/ Electronics/ Instrumentation).
• Minimum 10 to 15 years’ experience in product safety.
• Understanding of global mandatory / voluntary regulations like CE Marking, FDA, Health Canada, UL, CSA, INMETRO.
• Understanding of relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, ISO17025, etc.).
• Knows how to participate in Design Reviews from norm compliance perspective
• Knowledge of regulatory submissions.
• Knowledge of X-ray systems will be an added advantage.
• Prior experience in product design will be preferrable.
• Excellent Communication skills.
• Understanding and implementation of good document practice (GDP).
• Strong hold on Compliance standards.
• Knowledge of Product safety and regulatory.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

In this role, you have the opportunity to

• The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.

• The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.

• The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes

You are responsible to

• Be responsible for the design control in Sustaining Project Quality Assurance

• Ensures that appropriate Quality Plans are made that include all stages of the life cycle of the product and supports Quality Plan design

• Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs

• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design-related activities during the product/system life cycle

• Performs independent technical assessment of product quality performance and post-market product quality analysis

• Can Lead quality related problem-solving and root cause analysis during design and manufacturing

• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when required

• Act as a single point of contact (the person assigned to the project team) responsible for ensuring that hardware design meets quality and compliance standards for every milestone

• Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. CFR 820.30, and ISO13485. Drive project decision direction toward compliance, cross-functionally and globally. (Process)

• Ensure that program documentation (Design History File) is created, controlled, and archived per the Quality System. (Process)

• Lead, prepare, and participate/be the main escort in internal and external audits

• Frequently interacts with supervisors and functional peer groups. Interaction normally requires the ability to gain the cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

succeed in this role, you should have the following background, basic skills or experience

• Bachelor's/Master's in Engineering with minimum of 6-8 years work experience in a Medtech industry

• Strong quality assurance management experience, minimum 5 years in quality assurance - Mandatory

• Strong design control and new product development experience - Mandatory

• Risk Management

• Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP - Mandatory

• Strong analytical abilities

• Strong communication, problem-solving, and continuous improvement.

• Fluent in English both in writing and speaking

• Have experience in the medical industry or highly regulated industry

• Strong Influence Skills, Presentation Skills and Conflict Resolving Skills.

Onsite roles require full-time presence in the company’s facilities.
• Learn more about
• Discover
• Learn more about

You are responsible for

• Support global cross functional teams for assigned supplier transfer & sustaining projects
• Understands Products packaging requirements & specifications
• Creates engineering drawings & specifications of product packaging
• Creates 3D models, assembly and detailing including drawing conversions
• Apply GD&T and perform Tolerance stack-up analysis for components/Sub-system.
• Update designs of components and subsystems to improve manufacturability, performance, quality, and cost
• Review and ensure adequacy of supplier part qualification activities
• Work closely with the engineering to optimize packaging supply base for cost, lead time,

Quality, regionalization, standardization, supply assurance and compliance with regulatory & internal requirements

• Mechanical design and design changes of a module/sub system/ system
• Conduct DFM, DFA reviews with suppliers for Packaging solutions
• Identifying the suitable Packaging materials for designs and creating and releasing BOM
• Performing hand calculations for the design feasibility
• Must be very good and hands on with 2D & 3D (prefer - Creo, Solid works.)
• Hands on Windchill/ Agile / PLM software ‘s
• Work with manufacturing departement & ensure packaging designs are optimized
• Shall have hands-on expertise in Engineering change Management
• Develop test plans to ensure that the packaging meets specification.

To succeed in this role, you should have the following skills and experience

• BE/B.Tech. in Mechanical Engineering/Automobile /Industrial
• MS in engineering preferred
• 4-7 years of proven design engineering and product development experience
• Experience supporting global projects
• Experience with CAD software(s)
• Experience In working with ISTA standards & other Packaging standards
• Demonstrated strong analytical and problem-solving skills
• Knowledge of manufacturing quality systems and working in a regulated industry
• Experience with geometric dimensioning and tolerance
• Working knowledge of Microsoft Project, Excel, Power Point, and Word required
• Strong English written and verbal communication skills required

In return, we offer you

• A rewarding career in Philips with attractive package.
• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
• Attractive collective health insurance package
• Opportunity to buy Philips shares and products with discount