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
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