Hi Partner, looking for Senior Quality Engineer (Medical Devices) Senior Quality Engineer (Medical Devices) Duration: 6 Months contract Location: Philadelphia, PA Client: Pharma Start date: ASAP
Job Description • Lead quality engineer activities for risk management, as it relates to design and development, complaint investigations, and non-conforming materials. • Ensure high level of compliance to FDA QSR and ISO 13485 in all assigned areas • Work closely with internal departments (Operations, Advanced Operations and Research & Development) to provide risk assessments as required • Participate in project teams with internal departs to support product and/or process design and development activities • Perform literature review and analysis to support FDA submissions, utilizing medical knowledge and experience • Support the NC/CAPA process with risk assessments Mandatory Skills: Some Manufacturing Design/development experience , Medical device industry, complaint investigations , CAPA process ,quality engineer activities for risk management, FDA regulations. Qualifications/Work Experience . Minimum of three years working in medical or clinical setting, such as a registered nurse, preclinical RN, clinical affairs . Demonstrate the applied knowledge of FDA and/or International medical device regulations . Demonstrate the ability to work effectively in cross functional teams . Demonstrate problem solving and troubleshooting skills . Demonstrate interpersonal and communication skills . Demonstrate ability to exhibit a positive, energetic approach to teamwork . Demonstrate ability to advocate product excellence and quality . Demonstrate ability to respond to urgent needs of the team, with proven track record of meeting deadlines . Proficient utilizing computers, including Microsoft suite, Outlook and Adobe Education: Bachelor's Degree in a life science/medical related field of study. Regards Sam s...@sourcechip.net 732 917 4895 -- 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 http://groups.google.com/group/citrix-and-sap-problems. For more options, visit https://groups.google.com/groups/opt_out.
