Quality Specialist - 1st Shift

Regulatory Jobs; Northfield (NH); On-site; USD 45,000 - 62,000; Full time

Benefits offered by this job

Professional Development/On the Job 培训

Health and Wellness Benefits

Clean, Safe work Environment

Recognition and Rewards Program

Tuition Re-imbursement

Competitive Pay/Merit Increases

401k w/ Company Match

Employee Assistance Program (EAP)

Job summary

EPTAM Precision in Northfield, NH, is seeking a Quality Specialist for 1st shift to support our medical industry manufacturing. The role focuses on quality paperwork, FAI reviews, and ensuring conformance of MDHR/DHR before shipment, with involvement in audits and CTQ data analysis.

The ideal candidate has 3+ years in manufacturing, with strong documentation control and experience in regulatory paperwork for shipping.

Qualifications

• High School diploma or GED required; trade school preferred.
• 3+ years in a manufacturing environment; internships/PT acceptable.

Responsibilities

• Support customer Quality paperwork and shipping requirements.
• Perform FAI (First Article Inspection) reviews as per customer requirements.
• Develop, review, and approve Quality document packages for shipping.
• Organize and log MDHR/DHR for conformance before shipment.
• Assist with customer/system audits related to quality paperwork.
• Review CTQ data requirements when needed.
• Review customer POs for adherence to requirements.
• Ensure accuracy of paperwork, parts, and labeling prior to shipment.
• Generate daily GDP error reports for quality control.

Skills

Quality Assurance

FAI Reviews

Quality Documentation

MDHR/DHR

Audits

FDA Inspections

Data Analysis

Documentation Control

Education

High School Diploma/GED

Trade School Preferred

Tools

Document Control Software

MS Office

Spreadsheets

Job description

EPTAM Precisionis looking for a Quality Specialist - 1st Shiftto 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.

Benefits Include:

• 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)

Shift and Pay Details

1st shift - 7:00AM to 3:30PM (Monday through Friday)

POSITION SUMMARY:

The Quality Specialist is primarily for the following:

• Supporting our customers’ Quality paperwork shipping requirements.

ESSENTIAL FUNCTIONS:

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.

OTHER RESPONSIBILITIES:

• 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 AND EXPERIENCE:

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

O-B301ADP1570