EPTAM Precision Molding is looking for a Quality Engineer to join our team in Lancaster, MA

EPTAM Precision Molding is a trusted injection molding solutions partner. We are dedicated to supporting the complete product lifecycle in consumer products, healthcare, and defense industries. We're committed to helping our customers bring their products to market and streamline their supply chain.

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.

POSITION SUMMARY: Provide leadership to sustain a successful operation by managing all distribution, warehouse functions. Provides materials, equipment, and supplies by directing receiving, warehousing, and distribution services; and supervising staff.

JOB TITLE: Quality Engineer

POSITION SUMMARY: The Quality Engineer will be responsible for conducting the day-today validation activities in the manufacture of custom, plastic injection molded components used in the assemblies of various medical devices. This is a hands-on position with visibility on the manufacturing floor and quality lab and requires a high level of interaction with the production, product development, and quality teams. The engineer is responsible for supporting product development activities, injection mold validations, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives.

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

1. Draft validation protocols and writing validation reports (IQ/OQ/PQ)
2. Validate injection mold and work cell through IQ, OQ, PQ validation process.
3. Measure components utilizing vision systems and hand tools such as caliper’s and micrometers.
4. Support and oversee new process equipment validation and production.
5. Assist in corrective and preventive actions (CAPA) 
6. Implement statistical process analysis on new and existing products.
7. Assist in developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products
8. Assist workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
9. Participate in project meetings in order to keep projects on track until completion of validation into production.
10. Develop, review and maintain process documentation.
11. Ensures ISO and safety standards are adhered
12. Leverages industry practices and applies to internal systems and processes
13. Supports Lean Manufacturing and drives continuous improvement
14. Maintain contact with interdepartmental managers to provide feedback when dealing with process or material changes.
15. Understand and execute all plant policies and procedures.
16. Develop and maintain positive team member relations centered on mutual trust, dignity, respect, fairness, consistency, two-way communication, teamwork, and harmony.

OTHER RESPONSIBILITIES:

1. Responsible for identifying quality problems in products.
2. Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
3. Ability to define problems, collect data, establish facts, and draw valid conclusions
4. Ability to operate a personal computer including using a Windows based operating system and related software. Advanced PC skills, including training and knowledge of EPTAM’s software packages (IQMS).
5. Good housekeeping and safe working habits.
6. The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required.

MINIMUM JOB QUALIFICATIONS REQUIRED:

1. EDUCATION: Trade school graduate or associates degree or a combination of experience and education, Bachelor’s Degree in Plastics Engineering preferred. 
2. ISO 13485:2016 CFR, FDA, OSHA, environmental regulations
3. Equipment / process troubleshooting
4. Blue print reading
5. Design of Experiments / 6 Sigma
6. Knowledge of Scientific Molding principals
7. Medical device manufacturing experience
8. Experience: 5 years’ experience in an injection molding operation
9. Experience in a 24/7 manufacturing/molding operation
10. Proven success in maintaining positive employee relations
11. OTHER MINIMUM QUALIFICATIONS: Must possess good written and verbal communication skills with our internal and external customers. Basic knowledge of equipment. Advanced ability to read prints and use measuring equipment along with advanced math skills.
12. Demonstrates experience in performance development, teaching/leading, mentoring and/or organization development. Instills appropriate behavior in others in support of EPTAM values

ADP1166

ZZJ-240617-158