This person is accountable to provide leadership-caliper technical support to ensure Customer requirements are understood and implemented effectively across the QMS requirements. He/She will work cross-functionally contributing to Development and Manufacturing Engineering Qualification and Validation activities. Supports Engineering, Sales, and Quality by providing effective Non-conformance processing, Supplier control and Outsourced services integrity, Complaint handling, and related CAPA activities.
Provides regular QMS Quality performance analysis against established metrics and proactively initiates relative CAPAs and/or Continuous Improvement initiatives
Duties and Responsibilities
- Provide quality engineering support to the project team to ensure design controls are followed and quality system principles are implemented and followed throughout the design process.
- Identify and manage risk throughout the development process by ensuring a risk analysis for all products is completed
- and maintained using ISO 14971. Coordinate the development of a FMEA when applicable.
- Coordinate, review and approve design verification and validation plans. Review and approve all associated protocols and reports to ensure they meet the intended purpose. Ensure testing is sufficient to meet regulatory requirements and quality objectives.
- Ensure that deliverable requirements are received, filed and maintained in the DHF/Technical File.
- Ensure selected design components are qualified per internal documented requirements.
- Ensure selected suppliers are approved per VitalPath requirements.
- Define and implement incoming and in-process inspection and final product test requirements.
- When assigned, complaint handling, complete necessary investigation and failure analysis; accurately document finding and initiate corrective action activities as necessary.
- Support internal and external quality audits as needed.
- Generate quality system documentation as needed. Review and approve deviations and/or engineering change orders.
- Participate in manufacturing transfer planning and implementation.
- Ensure all finished goods meet established customer and company quality standards.
- Assist upper management in developing and maintaining the company quality vision and goals.
- Lead in the design, development, and prototyping of new devices, components and processes to meet the customer needs, lower costs and improve the quality of the product.
- Design and develop new test methods and equipment.
- When needed, author protocols and procedures for the testing, qualification, validation of product and processes.
Experience and Education
- Bachelor Degree in Engineering/Sciences/Manufacturing or equivalent related experience in Manufacturing or Quality Control.
- Previous experience in Class II or III medical device contract manufacturing or manufacturing with extrusion and complex catheter-type delivery system experience is required.
- Demonstrable skills related to root-cause analysis, SPC, equipment and process qualification, design and development validations, metrology, automation, and auditing are preferred
- Minimum of 10-years of experience at a leadership-role in an ISO/FDA catheter shaft medical manufacturing environment is preferred. Previous Supervisor/Manager experience in a technical contract manufacturing environment is preferred.
- Strong communication abilities, confident disposition, team player, and a robust toolbox of relevant SW applications (business and quality) is preferred.
- Understanding of ISO 13485 and FDA QSR requirements including design controls and risk management.
- Demonstrated ability to implement, execute, and maintain quality system policies and procedures.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems. Solid understanding of software capabilities and business applications.
- Ability to accurately prioritize and execute with minimal direction, interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans
- Familiar with the ability to use of inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rulers and microscopes.
- Broad knowledge of theory and principles of statistics and statistical process control and diverse knowledge of inspection and control methods, techniques, and documentation.
- Annual Bonus
- Life Insurance
- Paid Time Off
- Holiday Pay
Location: Roseville, MN
Employment Type: Full-time
Minimum Experience: 10 Years