Quality Engineer SE}

ARCH•Seabrook, NH

11d

About The Position

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 3 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

Requirements

Bachelor’s degree in related discipline, or equivalent experience will be considered.
Minimum 3 years related experience.
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).
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.

Nice To Haves

Experience and skills with CMM operation, programming, and general application of automated inspection techniques is a plus.

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.