Familiarity with ISO 9001 and ISO 13485 quality standards.
Proficient in technical writing and interpreting regulatory procedures.
Ability to analyze and present technical data effectively.
Experience in cross-functional collaboration and customer interactions.
Strong problem-solving skills for technical issues.
Knowledge of Epicor software is a plus.
Responsibilities
Oversee CAPA processes in collaboration with Manufacturing and Engineering teams.
Manage Return Material Authorizations (RMAs) and track RMA data for reviews.
Monitor Key Performance Indicators (KPIs) and report findings to management.
Conduct training sessions on internal quality procedures.
Manage non-conformances and facilitate the MRB process.
Represent Quality in product development and execute related plans.
Lead Supplier Corrective Actions Requests, ensuring thorough root cause analysis.
Benefits
Collaborative work environment with cross-functional teams.
Opportunities for professional development and training.
Involvement in innovative product development and quality assurance projects.
Full Job Description
Roles & Responsibilities:
Oversee CAPA, work with Manufacturing, Operations and Engineering to assist with containment, root cause analysis, corrective action, and preventive action. Conduct effectivity checks for CAPAs.
Return Material Authorizations, supports RMA requests from customers, tracks, and trends RMA data for Management Review, they will assist with RMA investigations as needed and provide feedback to the customer. As well as complaint handling.
Monitor and measure Key Performance Indicators (KPIs) and present findings during Management Review
Conduct training to internal procedures.
Non conformances and Material Review Board (MRB), disposition non conformances, disposition discrepancy material reports, manage MRB process as needed, tracks and trends nonconformance and MRB data.
Represent Quality in product development teams/projects. Work with various Engineering groups or QA Manager to develop and execute plans including quality plan, risk management, Process Failure Mode and Effects Analysis (PFMEA), control plans, production part approval process (PPAP), part qualification checklist (PQC)
Design verification and process validation (IQ, OQ, PQ)
Process capability (cpk). Understand statistics and how it impacts statistical control over process.
Lead Supplier Corrective Actions Requests (SCARs) - containment, root cause analysis, corrective action, and preventive action.
Ability to interpret Geometric Dimensioning and Tolerancing (GD&T)
Work as directed by manager.
Education & Experience :
Bachelor's degree in an Engineering discipline.
Knowledge of ISO 9001, ISO 13485 and other recognized international quality system standards.
Read, analyze, and interpret technical procedures and regulations.
Write technical reports, business correspondence, technical procedures, as well as administrative procedures.
Interpret and inspect to GD&T
Present proposals, data, and issues to Arcmed personnel at all levels.
Independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
Represent the department in frequent cross-functional interactions and possible customer, subcontractor, or vendor contacts.
Provide solutions to difficult technical issues associated with specific projects.
Determine and develop technical solutions to a wide range of difficult problems.
Experience with Epicor a plus.
Microsoft: Word; Teams; Visio; OneNote, PowerPoint, Outlook
Ability to operate media equipment such as tablets, smartphones, and other electronic equipment.
Ability to work with general office equipment.
Ability to work with and understand databases a must and the ability to learn technical skills.
