Quality Engineer Job at ARCH Medical Solutions - Seabrook, LLC
Summary:
Responsible for all engineering aspects of the company quality function. The quality engineer's responsibilities include designing quality standards, inspecting materials, equipment, processes, and products, developing quality control systems, and determining corrective actions. You will also work with managers and supervisors to implement quality measures.
Essential Duties and Responsibilities:
- Responsible for all engineering aspects of the company quality function.
- Receives customer contacts by telephone, fax, letters and in person. Responds to all customer quality inquiries; provides technical assistance to customer’s issues and determines and implements appropriate disposition.
- Provides technical assistance and training to production personnel.
- Assure that processes and machines are validated and that PFMEAs are established and maintained.
- Participate in Contract Review process to assure that Engineering Master addresses all customer requirements as documented in supplier agreements, procedures, work instructions and engineering drawings.
- Responsible for preparing quality control plans and IMS sheets.
- Responsible for defining inspection methods, selecting gauges appropriate for inspection activities, and maintaining calibration system.
- Assists in execution of internal and supplier audits.
- Participate in corrective action including investigation, root cause analysis, corrective action and preventive actions.
- Assist with receiving, first piece, in-process and final inspection as required.
- Responsible for assuring that assigned activities are performed in accordance with Seabrook Quality Management System.
- Responsible for creating and maintaining quality system documentation.
- Recommend new part verification technologies and if approved, assist in implementation.
- As applicable, understand and implement advanced Quality Software.
- As required, perform cross functional tasks until appropriate resources are in place.
Education and Experience:
- Bachelor’s degree in related discipline, or equivalent experience will be considered.
- Minimum 3 years related experience.
Job Knowledge, Skills and Abilities:
- Broad knowledge of FDA Quality System Regulations and ISO 13485 standard.
- Proficient with CMM, surface plate technology, shop math, and mechanical inspection instruments, and blueprints.
- Strong analytical skills and the ability to express technical concepts effectively, both written and verbal.
- Proficient at data collection, analysis, and presentation.
- Excellent computer skills and proficiency with MS Office and the internet.
Physical Demands:
- Prolonged periods of sitting at a desk and working on a computer.
- Lifting/carrying up to 25 pounds
EEO Disclaimer:
ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
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