Quality Specialist - 1st Shift
Eptam Plastics, Inc.
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Benefits offered by this job
Job summary
EPTAM Precision in Northfield, NH seeks a Quality Specialist for 1st shift to ensure accuracy of quality shipping paperwork, perform First Article Inspections, and prepare CTQ data for customer orders.
You will work with Sales and QA teams to compile MDHR/DHR, support audits, and maintain GDP-compliant documentation, contributing to on-time shipment and compliance with FDA/ISO standards.
Qualifications
- High School diploma or GED; trade school preferred.
- 3 years in a manufacturing environment; internships and PT acceptable.
- Experience with MDHR/DHR and FAI workflows.
- Ability to handle QA paperwork and audits.
Responsibilities
- Verify print requirements vs parts for quality shipping paperwork.
- Perform FAI reviews and complete applicable FAI requirements.
- Prepare Quality document packages for shipping purposes.
- Compile MDHR/DHR before shipment and store electronically.
- Support customer and system audits related to QA paperwork.
Skills
Education
Job description
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.
Full Time NH Facility 2XG, Northfield, NH, US
Salary Range: $19.00 To $25.00 Hourly
EPTAM Precision is looking for a Quality Specialist - 1st Shift to join our team in Northfield, NH, join us as we create devices being used in all facets of the medical industry. Our parts are seen in the following areas including; biopharma, molecular diagnostics, robot assisted surgeries, implantable devices, and much more. We look forward to sharing more about how we help the world around us.
Since its founding in 1981, EPTAM Precision, a Northfield, New Hampshire-based company, has been a leader in solving the most difficult challenges in plastic component manufacturing and CNC machining. EPTAM Plastics is the largest North American manufacturer of machined plastic products and assemblies. The professional team comprises over 285 engineers, production specialists, and dedicated quality control experts.
The FDA-registered, ISO 13485 center also features comprehensive automated inspection. With 10+ probe and vision coordinate-measuring machines (CMM), EPTAM Plastics can support you with metal-to-plastic conversions, material design support, and design for manufacturability using FMEA practice. EPTAM Plastics is the leader in complex multi-axis plastic machining using 3-, 5-, and 7-axis machine centers, CNC turning, Swiss, milling, routing, sawing, and drilling. We believe that the key to our success is combining world-class machining with our world-class metrology. Partnering those components with our proven processes and exceptional team help us bring the best to our customers and the world.
EPTAM Solutions, our parent company, is at the heart of manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep. Join our incredible team at any one of our locations and reap the benefits of an employee focused company. We excel at what we do for our customers, our employees, and the world.
- Professional Development/On the Job Training
- Health and Wellness Benefits
- Clean, Friendly, Safe work Environment
- Recognition and Rewards Program
- Tuition Re-imbursement
- Competitive Pay/Merit Increases
- 401k w/ Company Match
- Employee Assistance Program (EAP)
1 st shift - 7:00 AM to 3:30PM (Monday through Friday)
The Quality Specialist is primarily for the following:
· Supporting our customers’ Quality paperwork shipping requirements.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Compare print requirements with parts produced to determine the final quality of part for customer requirements of Quality Shipping paperwork.
- Perform FAI (First Article Inspection) reviews and the completion of the applicable FAI requirements based on customer requirements. *
- Work with applicable Sales team members to assist with FAI submittals, if required. *
- Develop, review, and approve Quality document packages for shipping purposes.
- Organize, compile, complete, and approve all necessary MDHR (Medical Device History Records)/DHR (Device History Records) for conformance before product shipment and scanning electronically to file and logging for storage purposes.
- Ability to work with outside storage facilities to recall and request services in relation to our company’s MDHR/DHR needs.
- Assist with customer and system related audits as it relates to raw material RTI (Receive to Inspect), FAI, MDHR/DHR requirements and Quality Shipping Paperwork.
- Compile, complete, and understand CTQ (Critical to Quality) data requirements, if required.
- Review customer PO for proper adherence to all requirements prior to shipment.
- Perform in-depth review of all paperwork, marked parts, bagged parts, etc. for accuracy prior to shipment.
- Generate daily report of GDP (Good Documentation Practice) errors identified within MDHR/DHR ‘s for notification to appropriate value stream.
- Achieve a classification of Independent or higher on all Quality Specialist competencies identified on the Quality Specialist Competency Checklist (enter form #).
- Employees must be able to relate to other people beyond receiving instructions. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.
- Essential function does not apply to all employees with the job title of Quality Specialist.
- Aid inspectors with Quality administrative duties when necessary.
- Training of individuals on the requirements of customer Quality Shipping paperwork.
- Training of individuals on the requirements and completion of MDHR/DHR.
- Training of individuals on the requirements of FAI.
- Good housekeeping, safe work ethics, and conducting self in a professional manner.
- Proper handling of all materials, parts, and equipment to prevent damage and loss of finished product.
- Represent the company as required during customer, internal and ISO audits, as well as FDA inspections.
- Understand the sensitivity of the data handled by the systems under your control and take appropriate measures to protect it.
EDUCATION: High School diploma, general education degree (GED) and/or trade school graduate preferred.
EXPERIENCE: Three (3) years’ experience in a manufacturing environment, equivalent combinations of education and experience accepted OR demonstrated ability to execute the Essential Functions for this position. Internships and PT experience acceptable.
LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: None
EPTAM Precision is looking for a Quality Specialist - 1st Shift to join our team in Northfield, NH, join us as we create devices being used in all facets of the medical industry. Our parts are seen in the following areas including; biopharma, molecular diagnostics, robot assisted surgeries, implantable devices, and much more. We look forward to sharing more about how we help the world around us.
Since its founding in 1981, EPTAM Precision, a Northfield, New Hampshire-based company, has been a leader in solving the most difficult challenges in plastic component manufacturing and CNC machining. EPTAM Plastics is the largest North American manufacturer of machined plastic products and assemblies. The professional team comprises over 285 engineers, production specialists, and dedicated quality control experts.
The FDA-registered, ISO 13485 center also features comprehensive automated inspection. With 10+ probe and vision coordinate-measuring machines (CMM), EPTAM Plastics can support you with metal-to-plastic conversions, material design support, and design for manufacturability using FMEA practice. EPTAM Plastics is the leader in complex multi-axis plastic machining using 3-, 5-, and 7-axis machine centers, CNC turning, Swiss, milling, routing, sawing, and drilling. We believe that the key to our success is combining world-class machining with our world-class metrology. Partnering those components with our proven processes and exceptional team help us bring the best to our customers and the world.
EPTAM Solutions, our parent company, is at the heart of manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep. Join our incredible team at any one of our locations and reap the benefits of an employee focused company. We excel at what we do for our customers, our employees, and the world.
- Professional Development/On the Job Training
- Health and Wellness Benefits
- Clean, Friendly, Safe work Environment
- Recognition and Rewards Program
- Tuition Re-imbursement
- Competitive Pay/Merit Increases
- 401k w/ Company Match
- Employee Assistance Program (EAP)
1 st shift - 7:00 AM to 3:30PM (Monday through Friday)
The Quality Specialist is primarily for the following:
· Supporting our customers’ Quality paperwork shipping requirements.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Compare print requirements with parts produced to determine the final quality of part for customer requirements of Quality Shipping paperwork.
- Perform FAI (First Article Inspection) reviews and the completion of the applicable FAI requirements based on customer requirements. *
- Work with applicable Sales team members to assist with FAI submittals, if required. *
- Develop, review, and approve Quality document packages for shipping purposes.
- Organize, compile, complete, and approve all necessary MDHR (Medical Device History Records)/DHR (Device History Records) for conformance before product shipment and scanning electronically to file and logging for storage purposes.
- Ability to work with outside storage facilities to recall and request services in relation to our company’s MDHR/DHR needs.
- Assist with customer and system related audits as it relates to raw material RTI (Receive to Inspect), FAI, MDHR/DHR requirements and Quality Shipping Paperwork.
- Compile, complete, and understand CTQ (Critical to Quality) data requirements, if required.
- Review customer PO for proper adherence to all requirements prior to shipment.
- Perform in-depth review of all paperwork, marked parts, bagged parts, etc. for accuracy prior to shipment.
- Generate daily report of GDP (Good Documentation Practice) errors identified within MDHR/DHR ‘s for notification to appropriate value stream.
- Achieve a classification of Independent or higher on all Quality Specialist competencies identified on the Quality Specialist Competency Checklist (enter form #).
- Employees must be able to relate to other people beyond receiving instructions. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.
- Essential function does not apply to all employees with the job title of Quality Specialist.
- Aid inspectors with Quality administrative duties when necessary.
- Training of individuals on the requirements of customer Quality Shipping paperwork.
- Training of individuals on the requirements and completion of MDHR/DHR.
- Training of individuals on the requirements of FAI.
- Good housekeeping, safe work ethics, and conducting self in a professional manner.
- Proper handling of all materials, parts, and equipment to prevent damage and loss of finished product.
- Represent the company as required during customer, internal and ISO audits, as well as FDA inspections.
- Understand the sensitivity of the data handled by the systems under your control and take appropriate measures to protect it.
EDUCATION: High School diploma, general education degree (GED) and/or trade school graduate preferred.
EXPERIENCE: Three (3) years’ experience in a manufacturing environment, equivalent combinations of education and experience accepted OR demonstrated ability to execute the Essential Functions for this position. Internships and PT experience acceptable.
LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: None
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