My name is Ajit 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: Quality Engineer* *Location: Devens,MA* *Duration:5 Months* *NEED LOCAL CANDIDATE OF MA* *Job Description: * *Job Description*: Assure all activities are in compliance with Design Controls and the relevant elements of the Quality System Regulations, with emphasis in site and corporate change control procedures for combination products and processes. Assist in the establishment of a phase gated structured development process for devices and lead the quality work stream activities for product and process development initiatives. Establish a complaint handling system for returned devices and conduct root cause investigations for internal and external field complaints in a timely and effective manner Assist in specification development through user studies, design of experiments (DOE s), and analysis of data using statistical tools and in-depth evaluation of variable factors. Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results. Work with cross-functional groups to assist in the development of engineering studies, design verification protocols, stability studies (for device) and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Oversee and/or perform measurement systems analysis (MSA s) for all critical performance test methods Lead Risk Assessment activities for Application, Design, and Processes Participate in design reviews and provide expert Quality input. Assist in the development and adherence to site Validation Master Plans, and execution of Operational and Performance qualifications as well as Process Validations for combination products in accordance with established regulations and approved site and corporate standards and procedures. Participate in product or process improvements and optimization utilizing Lean and Six Sigma methodologies. Participate in supplier, customer and/or regulatory agency audits. Qualifications BS degree in Mechanical Engineering or relevant engineering discipline. Advanced degree a plus. * Minimum of 7 years of quality engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry* Strong analytical, technical writing, verbal communication and interpersonal skills Thorough knowledge of quality systems, validation principles for product and manufacturing processes, engineering design fundamentals, Thorough understanding of regulations, familiarity of regulatory environment and industry trends for combination products Working competency of statistical programs (i.e., Minitab, SAS, etc.) Certified Quality Engineer (CQE) preferred Certified Six Sigma Green/Black Belt or equivalent preferred Certifications: Certification No items to display. Skills: Category Name Required Importance Level Last Used Experience No items to display. Additional Skills: 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) 248-1900 Ext.401 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, *Thanks.* *Ajit Singh* *e**Team, Inc. “**ACCELERATED HIRES**”* 1001 Durham Avenue Suite 201 South Plainfield, NJ 07080-2300 Office: 732-248-1900 x 401 Fax: 908-757-0800 [email protected] www.eteaminc.com -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" 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/us_itgroups. For more options, visit https://groups.google.com/d/optout.
