For the opportunities in time, please send resume at wd_darshana at hotmail variegate com. Please indicate in the email for what reason closely the job description matches your background and prove to be identical gaps, if any. Also, show your current compensation and compensation expectations. Please catalogue: All below opportunities require several years of endeavors experience and are only for limited candidates, with valid US work visa (at the time need arises for applicants with other types of visas, I pleasure mention that under that specific chance; fit). Also note, opportunities at the superficies are hot and the ones depress down may be at various stages of existence filled or not burning needs. This be stationed seems to be all about Quality Jobs – meet with below. (Also see below information not far from some upcoming events)
Junior & Senior CRA – Orangeburg, NY
Medical emblazoned bearing company with innovative treatment for inveterate heart failure, located in Orangeburg, NY, has openings instead of Jr & Sr. CRA. (Awaiting JD on the side of Senior CRA but feel free to commission resumes).
Junior CRA
Functions: Manage & organize administrative aspects in clinical department, be the occasion of & maintain site personnel contact intelligence, mass mailings, study binder preparation & arrangement; Collect regulatory documents, ensure accurary, note reciept of key documents & touch site regarding missing records; Collect & Review study-akin tracking systems to determine & take down status of clinical trial documents. Send notifications to the clinical experimental knowledge sites regarding their IRB renewal dates IRB; Maintain & final account study related files in compliance through department standard operating procedures; Review monitoring reports & co-operate with with the follow-up & resolve of noted observations; Work with clinical chagrin sites to ensure all required testing is forwarded to & current by the Core Laboratories; Consistently appliance study tools & training materials & comply with standard operating procedures and policies; Perform facts entry; Arrange periodic meetings for the Physician Adjudication Committee & aid the Clinical Director with the arrangement & conduct of the meetings.
Requirements: Bachelor’s literary in life sciences or related, by 1-2 years medical device clinical exploration experience; Experience in communicating with hospital administrators and clinical inquiry nurses; Working knowledge of FDA regulations and Good Clinical Practices; Excellent organizational skills; Good puzzle solving skills; EDC experience a plus; Conscientious person with an outstanding be ethic & strong personal discipline.
Quality Engineering opportunities- Middleton, MA
A guests located near Middleton, MA, and recognized for the re~on that a pioneer & global leader in healthcare technology & radically new measure for assisting or replacing the life-sustaining pumping duty of the failing heart, has following instant Quality Engineering opportunities.
Quality Engineer – Console Program Support
Requirements: Bachelors in EE & 5+ years implantable healing device experience and Design Control & hazard management experience required. CQE or CRE certifications are preferred. Comp: $80-95K
Functions: Understand patron complaint trends & patterns for stem cause understanding & corrective actions; Program second for console includes review of design/software confirmation & validation protocols & reports; convoy design control compliance reviews, performs dare to undertake analysis, and FMEAs; Instill reliability mindset inside team & provide guidance on reliability methods to team.
Quality Engineer – Disposables Program Support
Requirements: Bachelors in EE very much desirable. 1 year medical motto experience & CQE or CRE certifications are very much preferred. Comp: $60-85K
Functions: Understand buyer complaint trends & patterns for radix cause understanding & corrective actions; program sustenance on heart pump disposables including survey of design & process verification and validation protocols & reports; conducts design have the direction of compliance reviews, performs risk analysis, and FMEAs.
QA Manager – Mount Laurel, NJ
JOB Toulouse (Photo credit: JiPs☆STiCk)
An innovative healing device company working on treatment of chronic heart failure (“CHF”), has ~y immediate opening for a QA Manager. Salary appropriate with experience and will be in the consort of $125-145K.
Responsibilities: Management of Quality Systems branch; Direct supervision of Shipping Coordinator and Documents reign over; Day to day operation of wholly quality functions; Assure compliance with pertaining to home and international quality requirements; Ensure full Quality Systems programs to support multiple work manufacture; Prepare and execute all from without & internal audits; Work with lessen manufacturer to ensure that devices are manufactured in consent with US and international quality a whole requirements; Review all product complaints & make sure timely reporting of those events to home and international regulatory agencies as necessary; Participate in product development teams in successi~ behalf of Quality Systems. Identify and resolve persons of rank issues throughout product development process to assure successful audits and regulatory filings; Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties; Review and revision quality system documentation to ensure yieldingness with domestic and international quality and regulatory requirements; Schedule and full timely management review presentations; Manage the document services function to ensure that station systems documents, records and regulatory submissions are controlled; Schedule, leadership and assist in responding to in the mind audits; Schedule and conduct supplier audits; Maintain program to render certain adequate training of personnel on characteristic system documentation; Ensure that company employees are practised on the Quality Systems Regulation and solution international regulations and standards; Manage the program instead of handling product returns, returned product evaluations (and repair/rework, to what applicable), complaints and customer feedback in unison with internal policies and procedures; Maintain a functional CAPA regularity in compliance with applicable regulations; Maintain ISO 13485:2003 easiness registration in accordance with applicable standards; Provide leadership and supervision for Shipping/Receiving Clerk like it relates to completion of receiving inspections and other property related functions; Ensure that the Quality Systems derivative is carried out in accordance by GMP and ISO directives.
Requirements: Minimum Bachelors flat degree with 8-10 years’ actual presentation in Quality area or related actual trial in medical device arena; Good working knowledge of domestic and international charge and regulations; Excellent organizational skills and analytical and enigma solving abilities; Strong verbal and piece skills and good interpersonal and direction skills; Strong PC skills include Windows environment, Excel and internet. Spanish language skills desirable.
Director Quality Engineering – San Jose, CA
There is each exciting opportunity for Director Quality Engineering through strong capability and experience developing quality innovative medical devices. This place is responsible for effectively leading multi-cast quality engineering efforts of the organized being through technical expertise, interpersonal skills and a fair vision for execution.
Responsibilities: Manage resources to accomplish multi-project product examination, development and manufacturing; Contribute to strategetics and management of GMP/GLP effect; Provide Quality Engineering support as requisite to meet organizational objectives; Maintain capacity management systems necessary for development, including clinical evaluation; Develop quality plans and facts analyses for execution and review with leadership team; Develop test strategies DOEs and proof protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of fruit/process development and manufacturing; Design, table, and if necessary, performs specific testing because of existing and new products including supporting design and proceeding validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate horizontal surface of quality/reliability in purchased components is specified; Identify yield/process problems and ensure appropriate modifying agent actions are taken and verified to exist effective in eliminating problem; Remain current forward developments in field(s) of expertise and assiduity trends; Mentor junior staff members
Skills Required: Demonstrated predominance of technical teams in medical emblazoned bearing field; Demonstrated aptitude for and dominion of Quality Engineering principles; Demonstrated riddle solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical calculus for engineering and manufacturing; Strong capableness to operate independently and as a team clause; Teamwork: ability to work closely and effectively through team members and colleagues across engineering for the re~on that well as non-engineering disciplines similar as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable healing device design control and manufacturing processes ; Deep continued in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization character assurance; Demonstrated ability to interface effectively through professionals in the medical and biological sciences; Demonstrated scholarship of sound design principles, regulatory requirements, and effect and process validation procedures; Demonstrated improvement with computer aided design software and hardware disrespect. Formal training on systems and software is desired.
Also required: Bachelor’s class or higher in Engineering; Ten years least quantity experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of property management; Three years minimum direct personnel prudent conduct and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must receive experience in GMP electro-mechanical consequence design and manufacturing; Requires highly developed conduct skills and experience, including the power to map task interdependencies, multi-employment, prioritize such tasks, meet deadlines, and advance in successive, monitor and live within budgets taken in the character of well as the demonstrated ability to anticipate major milestones. Must be skilled at delegation, follow-up, and team building.
Senior Embedded Development Programmer – Mountain View, CA — Hot
A lop notch product development company with a honor for completing difficult projects on time and in successi~ budget, has an immediate opening in the place of a programmer. The company consults according to companies making wearable devices, home hale condition, products for the aging, medical devices etc & is known because work with sensors, wireless, and motion control.
Requirements: 10+ years continued in engineering design; Embedded programming skills without ceasing Windows and/or Linux; Experience with wide range of processors; Familiarity with digital circuits; Ability to design digital circuits. Ability to design analog circuits & supervisory actual observation would be a plus. The human frame needs to enjoy working with customers and own good communication skills. The part needs to work well on a team of remote from the equator performing engineers. The person indispensably to be organized. The body needs to work well with others and be flexible as schedules and priorities modify.
Post Doc Opportunity – TX & CA
There are immediate exciting opportunities that be able to lead you a fantastic career path in medical device engineering. A medical device company, found by a old leader of several successful companies, has particular post-doc openings in Biomedical by Electronics/ Electrical Engineering – with actual observation in heart/ brain related implantable devices in Texas and man and wife of opportunities with broad Biomedical/ Mechanical and/or Chemical Engineering background. Hands-forward experience is essential. For Electronics Engineering, actual feeling with hands-on circuit design, embedded systems design, prototype building or experience with battery-powered, base powered systems, etc. may be to be desired. The company is working steady exciting cutting edge technology to extricate large drug molecules orally. That and other careful search products pertain to solutions that are a single blend of traditional device technologies similar as electronics, software, mechanical engineering, and substance science, as well as pharmaceuticals, protein chemistry and solitary abode; squalid biology. Focusing on a tolerant range of technology and scientific disciplines, the visitors is seeking to address most compages unsolved or poorly treated clinical of necessity with highly innovative novel solutions.
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If you are a professional in #healthIT, #digital health, #internetofthings, #cloud, #bigdata or of the same nature, I would say this is the conversation, you don’t want to miss – It gives feigned opportunity to network with 4000+ professionals. Check revealed great agenda, top notch speakers & panelists at www.tiecon.org. Register with respect to #TiEcon (May 16 & 17 at Santa Clara Convention Center) at link http://tinyurl.com/kr2hkcw for the re~on that my guest & enter promo collection of laws tievalue to get $100 discount (sound till midnight, May 1).
Healthtechnology conference http://www.healthtechnologyforum.com, focused ~ward exploring pathways to sustainable health, is adhering May 20 in SF. Please annals for the conference as my intimate, with the discount code “HTF14-FriendOfOrganizer” and transmit me your first & last speak of at wd_darshana at hotmail dot com, to be in possession of $150 off the price of the ticket.
Dr. Sarvajna Dwivedi, fall of Pearl Therapeutics will talk attached Tuesday, May 6 at Cubberley, PA http://www.eppicglobal.org . Pearl Therapeutics was acquired through Astra Zeneca last year, for $1.15 B and was a winner of TiEcon’s TiE50 awards, brace years in a row.
http://www.bio2devicegroup.org meets each Tuesday in Sunnyvale, CA. Morning meetings are manumit, wealk-ins welcome. Dr. Alan Jacobs, Founder & CEO, PerceptiMed force of ~ talk on “Preventing Drug-Related Patient Injury and Death With Advanced, Cost-Effective Technology Systems“.
Feel unconstrained to send me an email in quest of any of these events at wd_darshana at hotmail diversify com and you can follow my updates steady Twitter @DarshanaN.
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