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:
- High energy, self-motivated with a high degree of accountability
- Thorough knowledge and understanding of quality philosophies, principles, methods, tools
- Knowledge and understanding of ISO 13485 and21 CFR Part 820
- Proficiency with MSOffice applications (incl. Word, Excel, PowerPoint, Project)
- Strong interpersonal skills
- Good communication and interpersonal skills
Education and/or Experience
- Bachelor of Science Degree in Engineering or similar discipline
- Three years of work experience with an ISO-certified and/or FDA-registered manufacturing company.
- Certified Quality Engineer (CQE) or equivalent certification preferred
- Strong background in Geometric Dimensioning and Tolerancing (GD&T) preferred
- High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.
- Experience with design review and design control
- Experience with FDA GMP practices, CAPA, and non-conforming materials (NCMR) processes
