What are the responsibilities and job description for the Quality Engineer position at ARCH Global Precision company?
Summary
Looking for an experienced quality engineer in medical device manufacturing with knowledge and practice in CNC milling and Swiss processes. Familiar with mechanical inspection techniques using micrometers, calipers, CMM, vision systems, etc. Experience creating inspection reports.
Key Functions of the Role
- Takes an active role in ensuring products meet corporate, industry, and regulatory standards
- Develops manufacturing control plans for internal and outsourced processes. Manages work completed by third-party suppliers or contractors, ensuring deliverables meet ARCH's procedures and standard of quality.
- Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing mechanical inspection techniques such as micrometers, calipers, CMM, and vision systems.
- Performs product and process risk assessment activities, including hazard analysis and design / process failure modes & effects analysis (DFMEA / PFMEA)
- Understands and communicates regulatory requirements to ensure compliance
- Develops, documents, deploys, and maintains various components of the QMS
Competencies To perform the job successfully, an individual should demonstrate the following competencies :
Education and / or Experience
