EUMDR Label Specialist – (URGENT REQUIRED) job vacancy in Syncreon Consulting, (Milpitas, CA)

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Job Details
Company Name : Syncreon Consulting
Company Location : Milpitas, CA
Job Position : EUMDR Label Specialist – (URGENT REQUIRED)
Job Category : Jobs in California

Job Description :
Company Description
We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.

Job Description
Job Description:

Manage / lead / execute labeling project(s) involving NPD and current commercial products.
Create / update the label artworks, label specifications, user manuals and its specifications and all other associated manufacturing instruction documents.
Providing input to the offshore team to execute their tasks as per customer guidance / process / procedure.
Create / update the design control documents, Bill of materials, drawings & other support documents and review of these documents from R&D’s technical specialty.
Create / update the labeling design specification documents.
Update the labels and user manuals as per EUMDR requirements
Manage transactions in Product Lifecycle Management tool & review and update Bill of Materials.
Create / Update Standard Operating Procedures & Manufacturing Work Instructions.
Need to handle change control management activities in PLM tools.
Accountable to initiate, plan and drive multiple projects throughout the project lifecycle.
Follow-up with Work Stream Leads from Manufacturing Plants and cross functional teams to assimilate project information daily.
Accountable to drive projects through planning, execution and close out phases.
Accountable for project communication with teams, peers, and leadership.
Manages project(s) risks and issues proactively.
Knowledgeable with problem-solving skills, able to find innovative ways to resolve issues.
Knowledgeable on EUMDR, 21CFR 820, ISO 13485, ISO 14971, ISO 15223, EN 1041 & ISO 20417.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor’s degree in Mechanical engineering or equivalent; Master’s degree preferred.
Minimum 5 years of industry experience with medical device labeling projects.
Experience working in a highly regulated industry (e.g., medical device, pharmaceutical) including hands-on experience in a medical device design control process.
Knowledgeable of medical device quality systems, FDA, EUMDR and applicable ISO standards.
Knowledge and hands-on experience in EU MDR related projects are an advantage.
Experience with problem solving methodologies.

EDUCATION and/or EXPERIENCE

Minimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering
5 Years of medical/ pharmaceutical packaging design and development experience

LANGUAGE SKILLS

Must be able to speak and write English fluently; must be able to communicate clearly and accurately.
Must be able to understand legally and technically written standards, regulations, and procedures.

Regards,
Mohammed Ilyas,
PH – 229-264-4029.

Additional Information
All your information will be kept confidential according to EEO guidelines.