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Please note that this is a 1 year contract position. SUMMARY:Compiles, reviews and releases device history records (DHRs) to support small scale manufacturing plant. Inspects raw material certificates of analysis and/or conformance for acceptance and usage. Responsible for compiling and maintaining bill of materials log. Responsible for all DHR, Incoming Inspection documentation filing, storage and logging for shipment to storage facility.As well as the ability and familiarity with document management systems for documentational updates as needed. Compile and present first pass acceptance metrics to leadership. Serve as point of contact for audit readiness of respective area.RESPONSIBILITIES:• Reviews Device History Records (DHR) and Incoming Inspection documents for accuracy, completeness and compliance with specifications as per applicable departmental procedure(s) for review of quality records. • Follows detailed procedures documented in SOP's, work instructions, forms and on check lists.• Strong documentation, attention to detail (accuracy), organizational and communication skills are required.• Compiles and Maintains the bill of raw materials log.• Responsible for mainting accurate records for all DHRs and Incoming Inspection documentation in adhereance with Retention Policies.• Responsible for the filing, logging of documentation and preparation for shipment of files to storage facility.• Learn and execute Change Admin Role II duties for the implementation of revisions, corrections and changes to procedures and methods associated with the role.• Ability to observe and participate in cross functional discussions, meeting and product reviews to learn about and support corrective actions for reoccurring problems as product release SME and quality representative.• Maintains a record of DHR errors, complies associated metrics for presentation to leadership. Generates and/or manages nonconformance’s respective to work area when required. Accountable to escalate any quailty concerns or issues to management.• Ability to summarize data and coordinate with manufacturing supervisors the efficient/timely release of product.• Ability to compile metrics data and identify trends as opportunities for improvement and ability to represent DHR Review during internal/external audits.• Serve as point of contact in site audits as SME for work area.• Perform other work-related duties as assigned.
OTHER DUTIES AND RESPONSIBILITIES:• Ability to travel across sites in order to manage team responsibilities (Note: Sites are within 2 mile radius of one another).• Must be detail oriented having the ability to work both independently and as a part of a dynamic team.• Ability to communicate effectively at all levels across the business and with key stakeholders and management.• Prior knowledge and application of Quality Management Systems (e.g. TrackWise, OTIS, DMS, WindChill and LIMS).• Must be a highly flexible individual who can work well in an environment with defined production deadlines and changing business needs.• Knowledge and application experience of Microsoft Office (Excel, Word, Outlook, Teams and Power Point).QUALIFICATIONS:• Requires a minimum of a bachelor's degree or equivalent.• Minimum of 24 months related work experience in a medical device or FDA regulated environment.• Working knowledge of goods manufacturing practices per FDA and ISO requirements and/or regulations.• Working knowledge of Microsoft office tools for communication, data analytics and performance reporting- strongly desired.• Prior experience desired in SAP, QERTS, LIMS, and Change Control• Process Excellence or Six Sigma training preferred.• Ability to travel (10%) (Note: 3 Distinct site locations are within 2 mile radius of one another).Applicants must provide their phone number. Reference job number A1693.