Senior Quality Engineer

Essential Duties and Responsibilities:

• Responsible for engineering aspects of the company quality function.
• Receives customer contacts and responds to 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, equipment, and test methods are validated and capable for manufacturing. Review manufacturing risks and assure PFMEAs are established and maintained.
• Participate in Contract Review process to provide quality assurance evaluations to assure conformance with established standards.
• Assure that Device Master Records address all customer requirements as documented in supplier agreements, procedures, specifications, work instructions, and engineering drawings.
• Provides input on quality control plans, including in-process inspections and final acceptance activities.
• Plan and/or conduct process capability studies and measurement system analysis as appropriate.
• Assist with defining inspection methods, selecting measurement tools, and inspection frequencies appropriate for inspection activities.
• Assists in execution of internal and supplier audits as requested.
• Participate in corrective action including investigation, root cause analysis, corrective action, and preventive actions.
• Assist with receiving, first piece, in-process and final inspections as required.
• Responsible for assuring that assigned activities are performed in accordance with Seabrook Quality Management System.

 

Education and Experience:

• Bachelor’s degree in related discipline, or equivalent experience will be considered.
• Minimum 5 - 8 years related experience.

 

Job Knowledge, Skills and Abilities:

• Broad knowledge of FDA Quality System Regulations and ISO 13485 standard.
• Proficient with surface plate technology, shop math, and mechanical inspection instruments.
• Proficient with reading, interpreting, and/or creating engineering drawings, blueprints, and technical specifications. Intermediate to advanced knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Experience and skills with CMM operation, programming, and general application of automated inspection techniques is a plus.
• 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:

• Regularly required to stand, reach and move about the facility
• Period of prolonged sitting at a desk and working on a computer.
• Lifting/carrying Maximum lbs: 50

 

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.