We create motion - drive systems from FAULHABER are masterpieces of precision engineering and electromechanics, at the limits of what is technically feasible. FAULHABER is an independent, family-run group of companies headquartered in Schönaich, Germany. At FAULHABER, we realize pioneering solutions for almost all markets and industries in which precision and reliability in the smallest of spaces are crucial, such as in aerospace, industry, robotics and medicine. The success of our products is based on the commitment of our employees - because behind every FAULHABER drive is the drive of our employees. Take us further with your drive and become part of our team.
JOB SUMMARY:
The Quality Assurance Engineer is an integral position for driving quality in product realization activities across the organization. Interfaces with all departments, vendors, and customers on quality issues. Responsible for implementing, monitoring, and providing continuous improvement for the Quality department. Identifies and conducts processes for developing product for incoming, in-process and final inspection requirements. Manages change activities to ensure ongoing product conformity, product traceability requirements and adhering to customer change agreements. Reviews, investigates, and drives to closure product conformity issues arising throughout the realization process. Creates corrective actions to drive improvements in the quality management system. Reports on product and processes using variable and attribute measuring instruments and techniques to ensure conformance with the company's quality standards.
Candidates must have PERMANENT WORK AUTHORIZATION in the U.S.
This is an On-Site position.
GENERAL RESPONSIBILITIES:
1. Manages Product Quality Assurance
- Participates in component design reviews and FMEA’s to ensure appropriate control plans (incoming, in-process and final inspections) are in place. Works with Engineering to create and approve control plans.
- Reviews/Approves change requests (component drawings, assembly and machine shop processes, control plans) to ensure adequacy of FAULHABER MICROMO verification/inspection activities and compliance with design specifications and customer agreements.
- Performs Customer Purchase Order (contract review) to ensure all specified requirements are understood, agreed upon and FAULHABER MICROMO quality systems achieve the intended results. Resolves any issues/concerns with the Sales team and customer.
- Manages the First Article Inspection Process. PPAP activities.
- Facilitates Source Inspections from customers.
- Assists the Quality and Regulatory Compliance Manager and ensures that adequate systems are in place to minimize product failures.
2. Manages Internal Audit Program – ISO 9001 / ISO 13485
- Manages the Internal Audit program as it relates to the ISO 9001 / ISO 13485 standards ensuring compliance to these standards.
- Ensures the internal audit procedure properly defines the criteria, scope, frequency, and methods for conducting internal audits, including process/product audits.
- Manages the internal audit team to conduct the audits in accordance with the planned scoped and time limit. Provides necessary training to ensure team competency.
- Provides the necessary reporting to Quality and Regulatory Compliance Manager regarding the status of the Internal Audit Program.
3. Manages the Change Management Process
- Identifies the customers impacted by the change and determines the appropriate level of notification and/or approval for each customer.
- Works with the Change Notification Board to finalize the actions to take for each change.
- Works with the Account Managers and customers where required to facilitate specific traceability and/or sample requirements.
4. Manages Non-Conforming Product.
- Responsible with the follow through and closure of MDRs as necessary to track defective product from incoming inspection as well as in process rejects.
- Contacts vendor directly to discuss product non-conformances.
- Initiates NCR’s (Non-Conformance Reports) as necessary to track product or process deficiencies and follows through to closure. Drives MRB meeting.
- Works closely with RMA Technician as needed on analyzing and resolving product return evaluations.
- Participates in the Monthly Production Meeting by providing feedback on product quality. Works and assists Quality Technician on NCR’s.
- Analyze trends of non-conforming product and based on results, initiates Corrective Action process, as necessary.
- Provides necessary reports to Quality & Regulatory Manager regarding status and trend analysis of non-conforming product.
5. Manages Concessions (Deviations)
- Where appropriate creates a Concession Form to submit for approval of non-conforming product and ensures the Concession Form details the non-conformance and proposed method of action.
- Ensures the proper assignment of the concession to all material and orders (Sales, Purchase and Production Orders) in the ERP system while the concession is active.
- Ensuring that the Concession Log is accurate and up to date. Properly executes the ERP system transactions when closing out.
6. Manages Corrective/Preventative Actions
- Initiates Corrective/Preventative Actions as necessary relating to internal procedure failures, in-process material rejects, and customer returned product.
- Responsible for ensuring proper containment and if necessary, recalling of non-conforming product.
- Works with the different teams to ensure effective identification of the root cause, corrective actions, and proper measurement evaluations for proof of effectiveness.
- Reports to the Quality & Regulatory Manager, the status of Open Corrective actions.
7. Metrology: CMM and Keyence (high-precision image dimension measuring systems)
- Lead programmer for quality.
- Organizes and maintains training for FAULHABER MICROMO employees, as necessary.
- Promotes best practices on the CMM and Keyence equipment.
- Manages the creation and validation of new CMM and Keyence programs.
- Provides support as the primary programmer on engineering projects.
8. Suppliers
- Performs supplier audits and evaluation as required.
- Travels to conduct strategic vendor Quality and Engineering evaluation for inclusion in the Approved Vendor List.
- Surveillance of suppliers.
9. Cross-trained and provides assistance to Receiving Incoming Inspection, RMA Customer Service and other personnel as instructed by the Quality and Regulatory Compliance Manager.
10. Conducts special inspection requirements and tests as deemed necessary by the Quality and Regulatory Compliance Manager. Ensures proper personnel are informed of test results when necessary.
11. Maintains and updates all QMS documentation, and quality contents as needed.
12. Supports engineering on new projects.
13. Prepares reports for the Quality and Regulatory Compliance Manager.
14. Provides training and tutoring to other personnel, suppliers, manufacturing process control, variation reduction, continuous improvements, etc.
15. Performs other duties as assigned or directed.
QUALIFICATIONS AND SKILLS:
- ISO 9001 and/or ISO 13485 knowledge and experience. ISO 14001 a plus.
- Excellent organizational skills and attention to detail while managing multiple projects simultaneously.
- Ability to quickly learn new processes.
- Ability to read engineering drawings and have thorough understanding of specifications.
- GD&T (Geometric Dimensioning and Tolerancing) a must.
- Working experience with electromechanical assemblies.
- In-depth knowledge of IPC-A-610 (Acceptability of Electronic Assemblies), IPC-A-620 (Requirements and Acceptance for Cable and Wire Harness Assemblies), and IPC J-STD-001 (Requirements for Soldered Electrical and Electronic Assemblies).
- Thorough knowledge of Windows based PC application and Microsoft Office programs.
- Working knowledge of ERP software, SAP preferred, and Document Management System software.
- Excellent mathematics/statistics knowledge, and application.
- Lean Six Sigma training, and mindset (reduce waste, drive improvements).
- Statistical Process Control (SPC).
- Ability to use various measuring instruments.
- Excellent verbal and written communication, and follow-through skills.
EXPERIENCE:
Bachelor’s degree (B.S.) or equivalent technical degree with a minimum of 5 years’ experience as a Quality Engineer.
FAULHABER MICROMO is an Equal Opportunity Employer.
