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 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

Language Skills

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to effectively present information to top management.