EPTAM Precision Plastics is looking for a Senior Quality Engineer 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 Plastics, 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 helps us bring the best to our customers and the world.

EPTAM Solutions, our parent Company, with locations nationwide, 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)

POSITION SUMMARY: The Senior Quality Engineer is primarily responsible for the following:

Act as the voice of the customer (VOC).
Lead Quality Assurance processes and ensure deliverables while mentoring Quality Engineers
Analyze quality processes for changes needed to assure standardization and consistency and report same.
Assist and train employees in quality and improvement methodologies.

ESSENTIAL FUNCTIONS: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Ensure the Document Control team is maintaining a physical filing system for DHRs, change notices, and other QMS documentation, and maintaining digital Quality System filing structure.
In addition to performing and executing these activities personally, train and mentor Quality Engineers on general quality processes, including, but not limited to:
1. Interpret specifications, blueprints, and job orders, and understand/interpret geometric dimensioning and tolerancing (GD&T)
2. Establishing and documenting inspection methodologies
3. Executing and documenting Gage Repeatability and Reproducibility
4. Executing and documenting Process Failure Modes and Effects Analyses
5. Executing and documenting Control Plans
6. Executing and documenting Capability Studies
7. Problem Solving
8. Technical Writing
9. Handling of nonconforming product
10. Scheduling and conducting cross-functional problem-solving collaborations.
11. Performing statistical analyses
CAPA/CARs / SCARs (Ownership through all phases with compliant documentation to CFR 820 and ISO 13485) – Responsible for assigned records through record closure, including documentation: Investigate situations including appropriate stakeholders/teammates, identify associated root causes, develop, and implement an action plan to address the root cause and problem statement, and verify effectiveness of actions executed to prevent recurrence.
Complaints (Ownership through all phases with compliant documentation to CFR 820 and ISO 13485) – Responsible for assigned records through record closure: understand customers’ expectations and meet them while considering suitability for escalation to a CAPA/CAR. Schedule and lead meetings to understand the situation, and address as per customer’s expectations.
Establish and adjust inspection documentation and procedures while coordinating with Engineering and Document Control to meet quality requirements.
Assist overall team to interpret specifications, blueprints, and purchase orders.
Perform first article, final inspections, and other inspection duties as required.
Perform Contract Review functions as requested such as reviewing customer requirements and specifications.
Perform review of Quality Agreements requested by customers considering impacts on other EPTAM functions.
Schedule and lead required Management Reviews
Supervise Quality Technicians and Quality Control team. *
Manage personnel with respect to performance reviews, hiring and orienting new employees, training, conflict resolution and disciplinary actions. *

* Essential function does not apply to all employees with the job title of Senior Quality Engineer.

OTHER RESPONSIBILITIES:

Identify, suggest, and lead changes to benefit the organization within the Quality System or Production
Ensure the promotion of awareness of customer requirements throughout the organization.
Ensure quality requirement flow down of customer purchase orders for products to be manufactured.
Identify quality system needs, including inspection materials, tools, and equipment necessary and convey to Quality Manager for strategic planning and budgeting purposes.
Work with Senior Quality Director and Engineering team to meet and exceed customer and ISO/FDA regulations.
Represent the company, as required, during customer, internal and ISO audits, as well as FDA inspections.
Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.

EDUCATION AND EXPERIENCE:

EDUCATION: High school diploma or general education degree (GED). Bachelor’s degree with a major in a relevant technical field (STEM) preferred, but not required.
EXPERIENCE: 5+ year(s) relevant quality assurance or managerial experience or training, equivalent combinations or education and experience accepted OR demonstrated ability to execute the Essential Functions for this position. Internships and PT experience may be considered . Experience with Software Engineering is preferred. Experience within a manufacturing, medical device company or other similarly regulated manufacturing environment preferred.
LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: Industry recognized Quality certification(s) preferred, but not required.

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ADP1485

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