Hello, I trust this finds you well. My name is Vivek. I am trying to reach you for *Quality Engineer* role with one of your premium direct client in *Dayton OH *Please suggest me a good time to talk, if you are interested.
*Title: Quality Engineer* *Duration: Contract to Hire * *Location:* *Dayton OH * Job Description: *Mandatory Skills:* · Hiring a Mechanical Engineer that is enthusiastic, self-motivated with great communication skills . · The Engineer will demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. *Preferred Skills:* 1) Experience of working while adhering to Medical Devices compliance standards like ISO13485, ISO14971, IEC60601, ISO10993, UDI etc. 2) Experience with documentation and Standards like 510(k)s, CFR 820 , ISO 13485 3) Experience of working with multiple Regulations like US FDA, MDD, Prop65, 4) Experience with statistical knowledge,tools and applying the same 4) 8+ years of related experience 5) Ability to work in direct, cross-functional and cross-cultural teams *Responsibilities:* 1. Creating, updating, reviewing and developing Quality Management System standard operating procedures and supporting work instructions based in ISO 13485:2003 and FDA Quality System Regulations 2. Perform verification/validation protocols and equipment qualifications (e.g. IQ/OQ/PQ) 3. Work with product development, manufacturing, service, quality assurance, and regulatory affairs, and purchasing team members to resolve engineering and change control issues. 4.Responsible for Statistical process capabality and generate related SPC reports 5. Responsible for Quality inspection planning & execution, Metrology experience 6. Independent, self-directed worker. Recognizes when it is necessary to ask for direction from senior level engineering colleagues. Initiates problem solving using creative and innovative design and process approaches 7. Attention to detail of process, procedures and documentation. 8. Use of good engineering practices, follows procedures and Quality System requirements, and effectively uses the organizations systems. 9. Interpersonal skills and composure in a change oriented culture. Possesses the ability to interact cross functionally with others to solve problems and negotiate solutions. 10. Ability to thrive in a fast-paced, team-oriented, manufacturing and new product development environment 11. Supporting Material Review Board (MRB) activities 12. Maintain reports of yield/defects and related activities for analysis and continual improvement Vivek Singh Enterprise Solutions Inc. Tel - *1-408-465-5253* <1-408-465-5253> | [email protected] -- 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 https://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
