- Description:
- Cogmedix is a team of talented and caring associates bringing OEM medical technology to life. Providing turnkey manufacturing services to a broad range of medical and dental OEM’s, Cogmedix delivers high quality products to market with compliance, competence, and commitment. Cogmedix provides a high level of flexibility in product launch and demand management and aligns itself with innovative companies that maintain similar high standards in honesty and integrity. Cogmedix is a subsidiary of Coghlin Companies, Inc., a privately held concept to commercialization firm spanning four generations. Visit Cogmedix and sign up for the e-Newsletter at www.Cogmedix.com.
- The Manufacturing Quality Engineer II will be a primary Manufacturing Quality Engineer on an assigned product account. The Manufacturing Quality Engineer II will lead and execute daily Manufacturing Quality Engineering efforts in support of manufacturing operations for their accounts while assuring compliance within Cogmedix Quality Systems, 21 CFR 820.30 and ISO 13485. The Manufacturing Quality Engineer II will be the technical liaison between Manufacturing Operations and the customer. The Manufacturing Quality Engineer II will review, edit and enter customer documentation within Cogmedix business systems. Additionally providing continuous improvement in documentation and process. The Manufacturing Quality Engineer II will often participate and lead in technical communications with the customer.
- Responsibilities:
- Under the direction of the Senior Manufacturing Quality Engineer, the Manufacturing Quality Engineer II will (for the assigned products accounts, and other accounts when directed by Senior Vice President of Engineering):
- Provide engineering, operational, Lean manufacturing, Six Sigma leadership and mentoring.
- Lead by example and promote the criticality of strict compliance adherence at Cogmedix.
- Lead in the training of personnel, including customers and suppliers on workmanship and quality standards.
- Compliantly implement and maintain Cogmedix procedures.
- Collaborate with Program Managers, Manufacturing Engineers and other departments to analyze customer ECO’s and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process.
- As part of the ECO Process and new proposal review, support the management of the customer BOM structure, creation of part numbers and structuring of Supplier Relationships and costs. Define PP/PA/Phantom, Commodity codes, documentation packages commodity and Work Instruction evaluation.
- As part of the ECO Process, support the generation and updating of DMR Indexes to ensure accuracy.
- As part of the ECO Process, provide ECO final approval for release for assigned product accounts.
- Ensure 100% ECO implementation accuracy.
- Ensure compliance to ECO implementation performance metrics goals.
- Effectively interact with customers and internal departments to create value-add propositions.
- Working with all internal groups, identify trends and process gaps and suggest and assist in the implementation of corrective actions and process improvements.
- Collaborate with internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs.
- Promptly respond to manufacturing floor issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.
- Collaborate with Program Management, Quality, and Operations to develop and approve optimal work order routings and Device History Records.
- Preparation of redlined documentation for sign offs.
- Lead and execute the development of Nonconformance documentation.
- Lead, execute and support complex troubleshooting efforts. Lead Manufacturing Quality Engineers in the generation of Rework Instructions and review and approve prior to implementation. Generate the more complex Rework Instructions and assist when needed.
- Lead and execute the development and deployment of Lean Manufacturing Cells.
- Working with the Quality Department, support the development of quality and inspection plans.
- Lead and execute regular audits of calibrated tools, tools requiring Preventive Maintenance and perishable floor stock items.
- Train Assembly Technicians, Test Technicians and Quality Inspectors on procedures as needed.
- MQE support for Scaled Product Launch/transitions.
- Lead and execute the generation of process validation/qualification documentation (e.g., validation protocols, IQ/OQ/PQ) and lead the implementation of protocols and completion of reports.
- Lead and execute the preparation of Process Flows, PFMEA’s, Time Studies and Value Stream Mapping.
- Evaluate Product Performance Data and Internal Metrics for stability and continuous improvements, utilizing Six Sigma practices where appropriate, including SPC (statistical process control).
- Support the development of quality and inspection plans.
- Generate Manufacturing Engineering Bulletins to communicate Continuous Improvement Opportunities to customers.
- Contribute in DFcx exercises.
- Generate Risk analysis, Risk management and Risk reports
- Lead Customer Specific Daily Team Meetings.
- Review new customer documentation packages.
- Lead, execute and support co-build activities.
- Support containment of nonconforming product.
- Approve rework instructions and non-conformances of assigned product accounts and associate did not initiate the non-conformance report, write the rework instruction or perform the rework.
- Participate in Quarterly Business Review for Manufacturing Quality Engineering department.
- Review and approve Equipment enrollment forms for assigned product accounts.
- Train Manufacturing Quality Engineers and Engineering Document Control Specialists.
- Support DFcx Engineering programs.
- Review procedures of customer processes.
- Lead challenge busters.
- Perform other activities as directed.
Essential Requirements:
- Positive attitude, self-motivator, and tenacious follow up required.
- Superior customer service attitude.
- Excellent teamwork, communication, interpersonal and leadership skills.
- Exceptional attention to detail.
- Strong electro-mechanical and opto-mechanical orientation.
- Experience in ISO 13485 certified and cGMP organizations preferred.
- Proven problem solver with multitasking skills and the ability to prioritize tasks to align with the goals of the department and organization as a whole.
- Knowledge of IPC 610 and 620 standards beneficial.
- Advanced ability to read, interpret and understand engineering documentation including assembly drawings, detailed component drawings, optical schematics, electrical schematics, pneumatic schematics, and wire run lists.
- Must be able to climb stairs and lift up to 30 lbs.
- Bachelor’s degree in science, engineering, or manufacturing discipline. Eight or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.
- 5+ year’s professional experience in medical subassembly and finished device manufacturing preferred.
- Advanced Level Skills in MS Word, Excel and PowerPoint such as keyboard short cuts, creating forms, table techniques, working with images, text, and pivot tables preferred.
- Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.
- SolidWorks and PDM experience is preferred.
- Advanced working knowledge of Lean concepts and Six Sigma Black Belt is preferred.
Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled__
Columbia Tech is an Equal Opportunity Employer. Columbia Tech 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.
