Job Description
JOB SUMMARY
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.
Our Strategy and Purpose
- We provide technology and supply chain solutions for the design and manufacture of precise fluid handling components for diagnostic and analytical. Instruments.
- We improve patient outcomes by helping solve the world’s toughest diagnostic and analytical challenges.
- We will be the recognized leader in heling 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 opinion makes us stronger.
- We are unafraid to make timely decisions, and we empower our people to make decision, execute them and move forward.
- We value people and take the initiative and hold themselves accountable.
- Challenging the status quo helps us grow. Look for and call out improvements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Essential duties and 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)
EDUCATIONAL REQUIREMENTS, QUALIFICIATIONS, and TRAININGS
- Bachelor’s degree in an Engineering discipline.
- Knowledge of ISO 9001, ISO 13485 and other recognized international quality system standards.
- Ability to read, analyze, and interpret technical procedures and regulations.
- Ability to write technical reports, business correspondence, technical procedures, as well as administrative procedures.
- Ability to interpret and inspect to GD&T
- Ability to present proposals, data, and issues to Arcmed personnel at all levels.
- Ability to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
- Ability to represent the department in frequent cross-functional interactions and possible customer, subcontractor, or vendor contacts.
- Ability to provide solutions to difficult technical issues associated with specific projects.
- Ability to determine and develop technical solutions to a wide range of difficult problems.
COMPUTER AND SOFTWARE REQUIREMENTS
- 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.
PHYSICAL REQUIREMENTS & WORK ENVIRONMENT
- Shall have essential physical skills; be able to run, squat, stoop/bend, kneel, climb stairs, be able to lift at least 50 pounds (or ¼ 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.
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.
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.
Job Type: Full-time
Pay: From $69,628.12 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to commute/relocate:
- Danbury, CT 06810: Reliably commute or planning to relocate before starting work (Required)
Experience:
- ISO 9001: 1 year (Preferred)
Work Location: In person
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