Job 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.
As a Manufacturing Quality Engineering technical leader, the Senior Manufacturing Quality Engineer will manage and oversee Manufacturing Quality Engineering activities along with initiating continuous improvement programs while assuring compliance within Cogmedix Quality Systems, 21 CFR 820.30 and ISO 13485. The Senior Manufacturing Quality Engineer will drive continuous improvement on their individually assigned product accounts in addition to departmental processes and procedures. The Senior Manufacturing Quality Engineer will drive technical communications with the customer.
Position Reports to:
Senior Vice President of Engineering, Cogmedix.
Responsibilities:
Under the direction of the Senior Vice President of Engineering, the Senior Manufacturing Quality Engineer will:
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, oversee 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, oversee the generation and updating of DMR Indexes to ensure accuracy.
As part of the ECO Process, provide ECO final approval for release.
Oversee 100% ECO implementation accuracy.
Oversee ECO implementation performance metrics.
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.
Oversee and ensure prompt MQE responses to manufacturing floor quality issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.
Oversee the development and approvals of optimal work order routings and Device History Records.
Review redlined documentation and review prior to sign off.
Provide support in the development of Nonconformance documentation.
Lead and oversee 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 oversee the development and deployment of Lean Manufacturing Cells.
Working with the Quality Department, support the development of quality and inspection plans.
Oversee regular audits of calibrated tools, tools requiring Preventive Maintenance and perishable floor stock items.
Oversee the training of Assembly Technicians, Test Technicians and Quality Inspectors on procedures as needed.
MQE oversight, management and scope of work for Scaled Product Launch/transitions.
Oversee and review 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 oversee 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.
Lead a team and contribute in DFcx exercises.
Oversee and approve Risk analysis, Risk management and Risk reports.
Oversee Customer Specific Daily Team Meetings.
Oversee new customer documentation package review.
Lead and oversee co-build activities.
Oversee containment of nonconforming product.
Approve rework instructions and non-conformances.
Lead Quarterly Business Review for Manufacturing Quality Engineering department.
Review and approve Equipment enrollment forms.
Train Manufacturing Quality Engineers and Engineering Document Control Specialists.
Support DFcx Engineering programs.
Lead and perform internal quality audits.
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.
10 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 training 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