Immediate Interview for right fit :: Mechanical Engineer

November 13, 2019

Immediate Interview for right fit :: Mechanical Engineer :: Santa Ana, CA

Hello,

Hope you doing great..!!

I am Mayank from ASK Staffing Inc., I am trying to fill a position with one of my client’s and wanted to check with you if you are considering new opportunities. Please forward this email to your connections In any case if you are not looking for career change.

I have attached the job details below for your quick review.

Position: Mechanical Engineer

Location: Santa Ana, CA

Full Time/ Contract

Position Summary:

Perform Supplier Engagement to obtain REACH & RoHS COC especially from long term Non-Responsive Manufacturer`s.
Coordinate with JJSV SQE team to get the Manufacturer information’s and expediting the Compliance document collection.
Preliminary review of CO Creation by coordinating with offshore team.
Understanding & In line with the requirements of JJSV Change Analyst to optimize the quality of technical documentation.
Ensure the Due-diligence review of collected COC documents as per SOP designed by JJSV.
Monitoring, status tracking & governance of the RoHS & REACH programs
Provide inputs to offshore team and providing solutions to enhance the project deliverables
Identify productivity improvement areas and implementation
Coordinate with JJSV Product Stewardship, EHS Specialists and R&D team to streamline the execution process.
Assist in the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel.
Project management and scheduling
Preparing work instructions / Standard operating procedures which are required to JJSV which helps to bench mark the process and maintain the good documentation practices.
Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental and franchise objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
Knowledge in Product Stewardship / Environmental regulations towards medical devices etc.,

Essential Responsibilities:

Coordinate with the offshore team execution and addressing technical queries to resolve the gaps.
Inform to JJSV key stake holders regarding ongoing challenges and bottlenecks within the supplier engagement activities.
Maintain and adhere to the project timelines as per RoHS / REACH regulation requirements to make sure the compliance and due-diligence.
Monitors and track the progress to meet the customer expectations and quality requirements.
Performs other related duties as assigned by management. (20%)

Qualifications

Education and Experience:

Essential:

Bachelor’s Degree - Scientific/Engineering Discipline or equivalent.
Minimum of 2 - 4 years of working experience in the R&D / Manufacturing / communication, organizational, negotiation and interpersonal skills.
Basis understanding of REACH / RoHS regulation is an added advantage.
Understanding and knowledge of regulations and standards (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001;
EU MDD/MDR;
Australian Therapeutic Goods Regulations No. 236;
Brazil GMP Regulations Resolution RDC n°16;
CMDR – SOR98-282;
Japan MHLW Ordinance No. 169;
21 CFR 50, 54, 56, 58; 21 CFR 812 and 814;
ICH GCP Guidelines, MDSAP, etc.)