Greetings, My name is Deepak and I am recruiter at eTeam Inc. eTeam Inc is a global contingency staffing firm servicing fortune 1000 clients globally.We have an excellent job opportunity with one of our client.
*Job Title: Validation Consultant* *Location: **Pittsburgh, PA* *Job Description:* Role: Testing Validation with Medical devices domain *POSITION SUMMARY:* · Support R&D, Manufacturing Department to ensure compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Medical Devices *DUTIES & RESPONSIBILITIES:* · Experience in setting up Quality Management system and understand ISO 13485/14971/IEC 62304 / QSR requirements. · Support documentation for CAPA analysis / Closure, Change Management & related QA activities. · Develop Post-Market Surveillance reports · Experience in acquiring the post market information to generate the Post-Market Surveillance report · Perform Risk Management activities as per ISO 14971 standard requirements – hands on experience (including, but not limited to, FMEA, Hazard Analysis etc.) · Research/Data gathering to support ongoing and new product in regards to: Hazards, Complaints review (internal and external (e.g. MAUDE) · Develop and execute Verification and validation protocols based IEC / AAMI and other regulatory standards as a member of product development teams, represents the QA function for Product Design throughout all stages of the Product Development Process. · Develop QA plan for Design Function and Manufacturing Activities. · Develop and initiate sampling procedures and statistical process control methods · Create periodic quality reports, supporting quality, operations, and engineering functions · Develop tools, test jigs and fixtures for verification / validation requirements · Collaborate with manufacturing personnel in writing and reviewing process validation protocols and reports · Summarize data using appropriate descriptive and inferential statistics. Collate, analyse and interpret statistical data for internal and external customers · Drive Internal audits, supplier audits, customer audits; properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements. ; Ensuring quality deliverables have been met and comply with regulatory and SOP requirements. · Ensures compliance with design control procedures and identifies/implements best practices. Documentation support for 510(k) and TF for FDA and MDD requirements. *POSITION & QUALIFICATION REQUIREMENTS:* *Bachelor of engineering with 6 -8 years of experience in Medical Devices Industry ( Lead Role)* · Medical Devices manufacturing Industry experience along with the knowledge of FDA / ISO 13485 , IEC 62304 , ISO 14971 standard requirements · Experience in Systems Design of Patient Monitoring devices / ultrasound scanners / infusion pumps/Radiology /Imaging systems etc. · Certified Internal Auditor per ISO requirements; Experience with conventional inspection and measurement equipment · Analytical ability in problem solving; Good communication skills, interpersonal skills, team work. A demonstrated commitment to company values. If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please call me ASAP at (732) 318-3811 even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you. Also, please take a few minutes to answer some of the questions below as they will help me qualify your candidature Full Legal Name as in Driving License/ Passport: Preferred email ID: Day/ Evening phone numbers: Current Location: Work Authorization: Earliest availability for Phone/ On-Site interview: Hourly Rate: Earliest possible start date: Two Professional References: Also, be aware that our client conducts an extensive background checks on candidates who are extended offers of employment. Sincerely yours, Deepak Mishra Gtalk ID- [email protected] eTeam Inc [email protected] (732) 318-3811 1001 Durham Avenue Suite 201 South Plainfield, NJ, 07080 ......................... Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to eTeam Inc. I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market. If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices. Thanks again.Deepak -- You received this message because you are subscribed to the Google Groups "SAP BASIS" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/sap-basis. For more options, visit https://groups.google.com/d/optout.
