The Senior Production Control Specialist creates, tracks and manages production work orders to ensure medical devices are produced and documented according to regulatory standards. This role plays a pivotal part in ensuring the seamless operation of our production processes by concentrating on production document package preparation (DHR) and assist with resource coordination. The DHR serves as a critical record that a device was manufactured accordingly, and this role is essential for product traceability and for successful regulatory audits.
Responsibilities:
- Prepare and maintain accurate work order packets, ensuring the inclusion of all necessary documentation for the production team. Including the preparation and printing of DHRs, production travelers, and collateral materials from the approved DMR/BOM. Ensuring compliance with revision control and regulatory requirements.
- Verification of comprehensive post-production documentation package to bolster organizational efficiency and ensure unwavering compliance with regulatory standards prior to Quality’s’ final review.
- Ability to navigate ERP to analyze material availability and expected material receipt date.
- Assist Production Supervisor / Manager in ensuring materials are present with each job order released to Production.
- Assist Production Supervisor / Manager in communicating material requirements to the Warehouse department.
- Assist Production Supervisor / Manager in organizing materials to meet Production goals.
- Assist Production Supervisor / Manager in Job Closing and Receipt to Inventory process.
- Provide support to Engineering, Manufacturing Engineering, and Quality through participation in process control activities as required.
- Support changes and releases of documentation for the production area including drawings, bills of materials, labels, and work instructions.
- Maintain serial number control
- Maintain clean, safe working environment.
- Maintain logs and tracking systems for all issued DHRs to monitor their progress and location.
- Manage work orders in preparation for and upon release to Manufacturing/Engineering. In support of these responsibilities, the Senior Production Control Specialist performs the following:
- Review Job status with Assembly Completion.
- Ensure material transactions are completed with product movement/consumption.
- Ensure all component materials are appropriately issued.
- Ensure sub-assemblies are properly processed.
- Reviews for appropriate serialization as required.
- Validation of production work orders in the ERP System, maintaining precise records of work orders and production progress.
- Collaborate with Production Planners and Production Management to distribute work orders and ensure deadlines are met.
- Ensure that all tasks and resources are methodically arranged prior to the initiation of production or ECO changes to avert discrepancies and ensure unimpeded operations. Efficient allocation and utilization of resources to maximize productivity of the production team.
- Serve as a point of contact between the manufacturing floor and other departments like quality, engineering, and planning for any documentation concerns or changes.
- Understands and follow good documentation practices in a cGMP and ISO 13485 environment.
- Document solutions and communicate process updates or improvements effectively to relevant stakeholders to maintain compliance and optimize production processes and implement enhancements.
- Identify and recommend solutions to documentation compliance issues that may arise through the work process.
- Assists in developing a production plan, lead times, resource, and timeline requirements in order to delight customers and meet mutually agreed to expectations.
- Provides excellent customer service and ensures customer satisfaction.
- May serve as part of the Scaled Product Launch Team.
- Other duties as required.
Essential Requirements:
- Positive attitude, self-motivator, tenacious follow up, and superior organization skills.
- Superior customer (internal and external) service attitude.
- Excellent teamwork, communication, and interpersonal skills.
- Ability to understand the BOM Structure and how the work package flows within production
- ERP expertise required. Epicor E10 preferred.
- Demonstrated ability to drive change.
- College degree preferred.
- Working knowledge of cGMP, FDA QSR, ISO 13485, SOP’s, work rules and safety guidelines preferred.
- 3+ years of planning experience in a high mix low volume medical device manufacturing environment preferred.
- Strong understanding of BOM structures and material planning required.
- Strong skill in Microsoft Office Programs (Excel, Word, Outlook, PowerPoint, Project, and Visio) required.
- Effective communication skills, both written and verbal.
- Must be able to read, write and comprehend English.
- A demonstrated commitment to company values.
Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
