Quality Engineer {SE}

**Essential Duties and Responsibilities** include the following. Other duties may be assigned. - Takes an active role to ensure products meet corporate, industry, and regulatory standards - Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements - Evaluates changes to design and/or manufacturing process for impact to DHF. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation. - 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. - Completes component part qualification activities not limited to, but including first articles, cap studies, gage R&R, and implementation of SPC requirements - Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing mechanical inspection techniques such as micrometers, calipers, CMM, and vision systems. - Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities utilizing knowledge in engineering fields - Performs internal quality and design control audits - Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA) - Supports product/process transfers during pilot and manufacturing builds - Conducts design for manufacturability reviews and suggests improvements to aid in capability and measurement analysis - Lead or assist in quality evaluation of returned products and support RMA program as assigned - Leads, participates in, or coordinates Internal Corrective Action initiatives as assigned - Participates in the technical review of design input specifications and design documentation for new and existing medical devices as assigned - Understands and communicates regulatory requirements to ensure compliance - Develops, documents, deploys, maintains various components of the QMS - Analyzes and controls processes to ensure highest possible quality products are created - Facilitates customer drawing reviews to ensure production readiness and inspect-ability - Facilitates process development/improvement and related documentation - Develops and executes process and equipment validation protocols and reports - Support management of the Nonconforming Material process, including facilitation of MRB meeting, root cause analysis, and corrective action implementation (CAPA Investigations) - Facilitates/leads risk management activities - Performs internal audits in accordance with internal audit schedule - Participates in customer and regulatory audits as required **Competencies** To perform the job successfully, an individual should demonstrate the following competencies: - High energy, self-motivated with high degree of accountability - Thorough knowledge and understanding of quality philosophies, principles, methods, tools - Knowledge and understanding of ISO 13485 and 21 CFR Part 820 - Proficiency with MSOffice applications (incl. Word, Excel, PowerPoint, Project) - Strong interpersonal skills - Good communication and interpersonal skills **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **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…