- 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.
- 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.
- Shall have essential physical skills; be able to run, squat, stoop/bend, kneel, climb stairs, be able to lift at least 50 pounds (or 1⁄4 own body weight).
- Shall have adequate vision, reading, writing, and documentation skills, and hearing to perform the essential functions of the job.
- Shall be able to visually differentiate colors.
- Will be engaged in speaking, sitting, walking, driving, listening, and in communicating both orally and in writing while performing his or her duties.
- Must be able to listen and respond to questions and instructions.
- Arcmed partners with the world's top Diagnostic and Analytical OEMs, Engineers, and Scientists to improve human health.
- We provide technology and supply chain solutions for the design and manufacture of precise fluid handling components for diagnostic and analytical instruments.
- Our product portfolio offers configurable fluidic components and engineered systems used for precise reagent and sample handling in instrumentation for OEMs in the In-Vitro Diagnostic (IVD), Next Generation Sequencing (NGS), and analytical chemistry markets.
- Arcmed offers labware and chromatography components to scientific laboratories in drug discovery and downstream biotech development workflows.
- We are recognized as a leader in helping engineers, scientists, and doctors to solve the world's toughest diagnostic and analytical challenges.
- We always act with intention and drive to achieve our purpose.
- Teamwork, collaboration, and diverse opinions make us stronger.
- We are unafraid to make timely decisions, and we empower our people to make decisions, execute them and move forward.
- We value people that take the initiative and hold themselves accountable.
- Challenging the status quo helps us grow. Look for and call out improvements.
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Manufacturing Quality Engineer - Danbury, United States - Arcmed
Description
The Quality Engineer is a working member of the Quality team whose primary responsibilities are listed below. They will report to the Quality Manager and ensure that Arcmed is compliant with its own standardized processes and procedures. Promote quality across the entire company by raising awareness and driving improvements. ****October Start Date****
Essential duties and responsibilities:
Qualifications:
Physical requirements:
About Arcmed
Our Values
The qualifications, physical demands, and work environment described herein are representative of those an employee will encounter and must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
Arcmed is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This document does not create an employment contract, implied or otherwise, other than an "at will" relationship.
The above noted job description is not intended to describe, in detail, the variety of tasks that may be assigned but rather to give the incumbent a general sense of the responsibilities and expectations of his/her position. As the nature of business demands change, so, too, may the essential functions of this position.
