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.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

Computer Skills

Proficient in all Microsoft Office applications (Word, Excel, Outlook)

Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit.

Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.