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Quality Engineer
Site: Ompi US
Department: Quality
Reports to: Site Head of Quality or QE Manager
Mission
The Quality Engineer supports all aspects of the Quality Management System, Product Realization, and Manufacturing Process Controls applying best practices from within the field of quality control to ensure that the materials, components, processes, and manufacturing techniques used produce high quality and reliable products. Working with cross functional partners, defines and generates quality control plans, production process controls, and procedures. They lead and support validation activities including statistical analysis. They execute process capabilities analysis and investigation of deviations and customer complaints, ensuring quality technical issue resolution. Engages with customers to invstigate and address quality issues and define acceptance criteria/attributes.
Essential Job Functions and Responsibilities
- Quality Process Monitoring
- Track and report key Quality metrics.
- Author, review, or approve technical reports evaluating trends and process/product performance data, identifying and clustering issues based on type, complexity and time using statistical methods.
- Collborate with crossfunctional team to investigate and trend deviations/OOS and customer complaints to identify CAPA to drive improvements to product quality. This may include authoring, reviewing, or approving investigation reports as well as conducting/facilitating root cause investigations and owning/executing resulting CAPA activities.
- Identify opportunities and implement solutions to drive continuous improvement in performance metrics and quality processes.
- Plan and perform regular audits of quality system and drive system improvements through the CAPA system.
- Quality Documentation
- Locally deploy global quality and technical specifications for products and services in cooperation with internal stakeholders.
- Verifiy customer product specifications aligns with site capabilities to support customer quality expectations and implement efficient tools in handling SG and customer specifications compliant with applicable regulations.
- Maintain repository for the relevant technical and quality documents ensuring a systematic and standard approach to facilitating knowledge sharing and availability of documentation.
- Validation Management
- Participates in carrying out new projects ensuring technical assistance and validation, as well as consultation with R&D Team to define appropriate processes to guarantee the quality and reliability of the products.
- Supports the definition of the required qualification and validation activities, aimed at ensuring the compliance of the quality management system with applicable standards and requirements.
- Provides timely and accurate validation documents, including creation/review/approval of internal protocols and reports as well as consultation/review/approval of thirds party protocols and reports.
- Collaborate with Operations and Engineering to ensure execution of the qualification and validation activities meet and timing and requirements defined in the approved plan, guaranteeing the compliance with applicable standards.
- Guidelines and Procedures
- Support the development and manufacturing of medical devices in conformance with applicable US FDA and ISO 13485 requirements.
- Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
- Build appropriate guidelines and best practices to support and facilitate the communication pursuing a trustful partnership with internal stakeholders, in line with the applicable standards and policies.
- Train quality staff in standard metrology, GD&T, SPC and new inspection techniques.
- Project Management and Support
- Responsible for quality planning of all new development programs and design transfers to the site.
- Executes the assigned projects related to product and process quality improvement, including development and implementation of any new or required inspection methods.
- Collaborate with Operations, Process/Facility Engineers, and/or Validation Engineers to execute process and equipment qualifications.
- Quality Audit/Inspection Support
- Participate in inspections/audits by providing applicable information to fulfill requests of inspectors/customers with potential interactions to explain relevant data, documentation, and rationale.
- Relationship Management
- Interacts regularly and effectively communicates with the key internal leaders and team as well as relevant stakeholders aimed at building level of awareness on quality vision supporting them in facing quality issues.
- Patricipate in customer technical meetings in order to provide technical services supporting relevant quality topics to ensure customer requirements are understood and fulfilled.
Other Requirements of Job
Safety
- All employees are expected to comply with all safety requirements promoting a Safety First culture striving for an injury free workplace.
- PPE such as Safety glasses, safety shows, hearing protection, and gowning required in designated areas.
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Tasks may include standing, walking, bending, and sitting.
- Training Requirements
- Internal QMS training
- Relevant training on use of IT tools (i.e. ERP, Office, company applications)
- Auditor training
- SPC, process controls, metrology (GD&T), Gage R&R, Calibration
- Certifications such as ASQ CQE, CQA, CQM desired
Work Environment
- Job is located onsite with periodic flexibility such that business needs are met
- Professional offices
- Work may be required in an ISO 7 or 8 clean room environment.
- Glass forming, needle assembly, and packaging facilities
- Warehouse areas (limited)
- Off-shift support may be required periodically to meet business needs
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