9 months contract to start with
This position will be reporting to the team helping to remediate FDA and other Agency Audit findings. The following skills are required for this job:
• Responsible for defining and implementing Manufacturing processes for new products and managing the changes for exiting products.
• Responsible for defining, selecting, and validating Manufacturing equipment.
• Fundamental understanding of Lean Manufacturing Principals
• Ability to generate process flow maps and utilize results to improve processes and manufacturing operations.
• Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacturing.
• Responsible for creating the code for the templates necessary to run the paperless factory.
• Lead teams in performing and updating Process FMEA risk management.
• Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
• Ensure that all appropriate documentation, drawings specifications are generates in compliance with Philips procedures and regulatory requirements (US FDA and ISO).
• Knowledge of IQ, OQ, PQ Validation Strategies.
B.S. in an Engineering discipline or Technical field is highly desired.
• Prefer 3-5 years’ experience
• Microsoft Office applications, including PowerPoint and Project
• Basic understanding of software coding in any standard language.
• Statistics, including SPC and DOE
• Experience with process and equipment validations
• Knowledge of GMP ISO-14971, and ISO-13485
• Experience with FDA-regulated medical device manufacturing helpful
• Experience in creation and review of process FMEAs strongly preferred
• Experience reviewing nonconformance data to assess risk in existing process FMEAs strongly preferred
Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com