*Hello,* *GREETINGS !!*
*This is Neha from Apetan consulting,* *Please find the below job description and send me your update resume matching to it along with Contact details, Current location, Visa and Availability ASAP.* *POSITION: QUALITY ENGINEER* * INTERVIEW: Phone than F2F Interview* *LOCATION: Caledonia, MI* *DURATION:4 MONTHS* *START :ASAP* *Job Overview:* *Need candidates with heavy manufacturing experience . Key experience will be FDA, ISO and Regulatory experience* *Must have experience with Medical Devices & have a Bachelors Degree in Engineering. No exceptions.* · Supports validation and risk build activities with manufacturing and engineering group · Leads Customer Complaint Investigations · Responsible for customer complaint product dispositions · Performs root cause analysis and implements effective corrective action for customer complaints and CAPA’s · Assess quality performance using statistical and analytical methods · Initiates non-conforming dispositions · Initiates CR’s and CO’s · Develops and implements test methods and procedures for inspecting, testing and evaluating product and processes · Develops gauging methodology for products · Performs capability studies and gage R&R · Reviews and approve calibration records · Continuously identifies areas of improvement in the manufacturing processes that would enhance product quality and partner with manufacturing to implement the improvements · Conducts trend analysis: collect data, create, update & maintain trend charts and reports · Analyzes improvement opportunities through MRB monitoring · Supports Quality Improvement Coordinators to ensure products & processes comply with regulatory and QSM requirements · Develops trainings to build quality awareness · Reviews and approves risk management/risk analysis documents · Participates in PFMEA and DFMEA reviews · Participates and provides input in design review meetings, partnering with NPD and Manufacturing during the entire development and transfer process · Supports manufacturing and engineering to resolve technical issues *EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:* · Bachelor’s degree in Engineering or a technical field preferred · 3+ years of experience responsible for Quality improvement projects preferred · 2+ years of experience in a regulated industry experience that includes FDA and ISO requirements preferred · ASQ certification a plus · Communication – displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels · Flexibility and Adaptability – make effective decisions and maintain effectiveness under changing circumstances and priorities · Teamwork, communication, positive attitude required to support the manufacturing environment · Ability to read and analyze technical prints and drawings · Problem Solving – able to perform root cause analysis and implement effective corrective actions · Project Management – able to effectively manage and complete multiple projects simultaneously · Conduct Process Failure Mode and Effect Analysis (PFMEA) · Experience in 3D modeling, “Solidworks” preferred · Computer Skills – Excellent computer skills including but not limited to Microsoft Office Suite *QUALITY AND REGULATORY REQUIREMENTS:* · Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions · Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations -- *Neha Kumari |* *Technical Recruiter* | *Apetan Consulting LLC* Tel:201-620-9700* 106 | Fax: 201-526-6869 | 72 Van Reipen Avenue # 255 Jersey City, NJ 07306 | n...@apetan.com | www.apetan.com | -- You received this message because you are subscribed to the Google Groups "Citrix and Sap problems" group. To unsubscribe from this group and stop receiving emails from it, send an email to citrix-and-sap-problems+unsubscr...@googlegroups.com. To post to this group, send email to citrix-and-sap-problems@googlegroups.com. Visit this group at https://groups.google.com/group/citrix-and-sap-problems. For more options, visit https://groups.google.com/d/optout.
