Quality Engineer SE}

ARCH•Philadelphia, PA

About The Position

The Quality Engineer SE will take an active role in ensuring products meet corporate, industry, and regulatory standards. This role assists management in implementing and maintaining a quality system compliant with ISO 13485 and FDA quality system regulation requirements. The engineer will evaluate changes to design and/or manufacturing processes for impact to the Design History File (DHF), leading and executing activities to close any gaps. They will develop manufacturing control plans, manage third-party supplier work, and complete component part qualification activities. The role involves developing and initiating standards for inspection, testing, and evaluation, performing internal quality and design control audits, and conducting product and process risk assessments. Additionally, the Quality Engineer SE will support product/process transfers, conduct design for manufacturability reviews, lead evaluations of returned products, and coordinate internal corrective action initiatives. They will also participate in technical reviews of design input specifications and documentation, understand and communicate regulatory requirements, and develop/maintain components of the Quality Management System (QMS). The engineer will analyze and control processes, facilitate customer drawing reviews, and support process development/improvement. This role also includes developing and executing process and equipment validation protocols and reports, and supporting the management of the Nonconforming Material process, including MRB meetings, root cause analysis, and CAPA investigations. Finally, the Quality Engineer SE will facilitate/lead risk management activities and participate in customer and regulatory audits.

Requirements

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
Bachelor of Science Degree in Engineering or similar discipline
Three years of work experience with an ISO certified and/or FDA registered manufacturing company.
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
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to effectively present information to top management.
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.
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
Proficient in all Microsoft Office applications (Word, Excel, Outlook)

Nice To Haves

Certified Quality Engineer (CQE) or equivalent certification preferred
Strong background in Geometric Dimensioning and Tolerancing (GD&T) preferred

Responsibilities

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