Dear Partners, Please find the below requirements, and share your profiles to [email protected]. Requirement 1; Role: Sr. Quality Engineer Location: Jacksonville, FL Duration: 6 Months Rate: Open
Job Duties: • Completes Design History File documentation • Develops and implements strategic plans • Develops plans to evaluate process repeatability and stability • Performs deliverable checklist audits • Performs process and equipment validations • Reviews product performance data to identify trends • Supports manufacturing, development, and implementation processes • Utilizes FMEA within process development • Ensures compliance with GMP’s, • Generates documentation for engineering protocols and reports Required Skills and Certifications: • Looking for a Senior Quality Engineer to support New Product Development projects • Should have medical device background, quality engineering experience working on product development teams • Hands on experience with process qualification, design verification & validation, risk management, and product requirements flow down. Certification and Engineering skills: • ASQC • Design Controls, DHF, and Engineering Documentation • QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance Requirement 2: Role: Quality Engineer (Electrical) Location: Minneapolis, MN Duration: 10 Months Rate: Open LOCAL CANDIDATES ONLY….. Job Duties: • Completes Design History File documentation • Design of Experiments (DOE) and Statistical Process Control (SPC), • Determines manufacturing operation requirements and process parameters • Develops advanced manufacturing systems and processes, • Develops product and process improvements, • Performs process and equipment validations • Provides technical support to other engineers, • Reviews product performance data to identify trends • Specifies and implements process lay-outs, • Supports manufacturing, development, and implementation processes, • Utilizes FMEA within process development • Ensures compliance with GMP’s, • Generates documentation for engineering protocols and reports • Implements quality system improvements • Writes engineering and manufacturing specifications Required Skills and Experience: • We need one engineer with an electrical background, they will be assigned to our electronic instrument area and will need an electronics quality background. • Should prepare and review Qualification Test Plans and Reports for assigned projects. • Provide technical support for technicians performing the testing. • Assure the resolution of all issues raised by the testing. • Leads and/or participates in corrective/preventive action teams in resolving production and customer issues. Dispositions in process materials/components that are flagged for non-conformance to standard processing • Leads or participates in audit/assessment of the manufacturing operations. • Review changes to products in production for reliability impact to aid in the correction of process, design or materials problems. • Leads process improvements and process streamlining. • Evaluate field performance of assigned products by reviewing field data, supporting technicians to evaluate unusual returns and supporting Technical Services and Consumer Affairs in responding to customer. • Provides statistical support by leading creation of manufacturing related metrics for improvement purposes. Requirement 3: Role: Manufacturing (Quality) Engineer Location: Minneapolis, MN Duration: 10 Months Rate: Open LOCAL CANDIDATES ONLY….. Role: • This position is responsible for sustaining, improving, and controlling the overall performance of processes within the capacitor product line • The product engineer interacts closely with the Operations team as well as several engineering disciplines such as Process Development, Quality, and Reliability Engineers. • This position will understand the product performance and the effects of the manufacturing process on the product while ensuring quality and compliance excellence. Position Duties: • Identify process improvement opportunities via analysis and hands-on interaction with designated processes, including troubleshooting of mfg issues when they occur. • Utilize project mgmt skills to drive continuous improvement initiatives to optimize yield, quality, cycle time while reducing scrap and rework. • Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.q. tooling or equipment qualifications, software qualifications, risk assessments, and work instructions). • Participate in and/or lead issue resolution activities to accomplish a solid root cause investigation with corrective and preventative action that is documented as required. • Make use of appropriate quality tools, such as MSA, SPC, hypothesis testing, tolerance intervals, DOE and capability studies; to measure, monitor, improve and control the mfg line and select processes. Required Skills: • Bachelor of Science in Engineering, or related science (Mechanical, manufacturing or engineering discipline with manufacturing experience) • Minimum of 4 yrs experience • Experience with small component assembly manufacturing processes • Experience with Medical Device Manufacturing / Assembly Processes • Strong written and verbal communication skills • Ability to handle multiple tasks concurrently • Proficient with Minitab and Microsoft Office (Word, Excel, PowerPoint) • Experience reading & understanding assembly work instructions & engineering specifications. • Aptitude for quickly learning and as simulating a broad array of information • Excellent data analysis skills and proficient in the use of statistical tools for problem solving Knowledge in Lean Manufacturing / Six Sigma methodologies Preferred ISO 13485 experience/cGMP experience Preferred Requirement 4: Role: Packaging Engineer Location: Santa Rosa, CA Duration: 10 Months Rate: Open Job Responsibilities and Requirement: • Responsible for the design, development, and support of package systems for sterile medical devices including components, assemblies, and labels Position Responsibilities • Development of packaging and labeling components, and assemblies for sterile (sterilized by Ethylene Oxide, Steam, Gamma methods), medical products in support of R&D / new products • Coordination and communication of packaging technology and designs with project teams as part of the Product Development Process • Provide technical recommendations and coordinate introduction / implement changes in the packaging process and materials. • Actively collaborate with Packaging and Labeling peers within CardioVascular to identify and implement best practices, packages and processes. • As requested, participate on cross-functional, cross-site project teams focusing on packaging, technology and processes improvements • Know FDA and ISO requirements related to packaging and labeling, how to conduct thorough validations • Experienced with IQ/OQ/PQ as part of packaging processes • Draft technical documentation including package testing protocols and validation associated with the qualification and release of package designs • Process development and support for packaging assemblies for manufacturing • Develop plans to establish proof shelf life (shelf life) accelerated and real time. • Proficient in the use of computers, intranet/internet, PC applications, and labeling systems • Manage projects and deadlines to ensure all new product and package improvement deadlines are met • Serve actively in the identification of suppliers, testing and approving materials, including liaison with the vendors. Required Skills: • BS Packaging or Engineering (Mechanical or Materials) • Minimum of 2 years medical device packaging experience • Certified Packaging Professional (CPP) preferred. • Experience with automated and/or semi-automated packaging equipment and processes • Knowledgeable in ISO, ASTM, ISTA standards related to packaging. • Solid proficiency in MS Word, Excel and statistical analysis software Preferred Qualifications • Experience with data base driven labeling systems • Experience with DFLS, DFM, process development and design of experiments (DOE) methodology Thanks & Regards, Lakshmi P Talent Acquisition Executive 7950, Dublin Blvd, Suite # 309, Dublin, CA 94568 Phone: 408-409-7521 [email protected] www.techsophy.com -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. 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