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 [email protected] 732 917 4895 -- You received this message because you are subscribed to the Google Groups "SAP Workflow" 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/sap-workflow. For more options, visit https://groups.google.com/groups/opt_out.
