Quality Engineer

EPTAM Precision Molding is looking for a Quality Engineer at our Phillipsburg, NJ facility

EPTAM Precision Molding hosts a tightly controlled facility with ISO Class 7 and 8 cleanrooms. Our commitment to exceptional service is reflected in our continuous investment in operational upgrades and the utilization of advanced Toyo and Arburg molding machines. We take great pride in our ISO 13485:2016 and ISO 9001:2015 certifications.

EPTAM Solutions, our parent company, with locations nationwide, is at the heart of manufacturing. As a medical device manufacturer with locations throughout the United States, 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: The Quality Engineer is primarily for the following:

• Assisting with monitoring and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485 and 21 CFR part 820 (Quality System Regulation).
• Providing focused, Quality Engineering support via communication to department managers of the Quality Management System including Complaint, CAPA, Risk Management, Supplier Quality and Document Control processes.

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

• Ensure Quality Management System documentation and reporting of all Quality-related issues and projects are maintained.
• Identify and support Quality Manager by executing plans and actions to achieve assigned quality goals.
• Coordinate the tracking and closure of Quality issue-related documentation and Change Control related to RMA, NC, CAPA, and MRB System.
• Support process owners and department managers/value stream leaders in methods of process improvement and process control related to RMA, NC, CAPA, and other Quality Management issues or concerns.
• Monitor customer requests and ensure successful execution of customer-driven acceptance activities.
• Develop, vet, and maintain inspection plans.
• Draft IQ, OQ, and PQ protocols, execute validations within work cell(s), and write validation reports (IQ/OQ/PQ) for equipment and processes.
• Measure components utilizing advanced measuring equipment (i.e., CMM, vision systems, etc.) and various hand gages such as calipers and micrometers.
• 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.

OTHER RESPONSIBILITIES:

• Represent the company, as required, during customer, internal and ISO audits, as well as FDA inspections.
• Support communication that ensures management and employee understanding of current Good Manufacturing Practices (cGMP).
• Leverage industry practices and apply to internal systems and processes.
• Ensure quality requirement flow down of customer purchase orders for products to be manufactured.
• Identify quality system needs and convey same to Quality Manager for strategic planning and budgeting purposes.
• Implement statistical process analysis on new and existing products as needed.
• Identify, suggest, and lead changes to benefit the organization within the Quality System or Production.
• Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.

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.

EDUCATION AND EXPERIENCE:

• EDUCATION: High School diploma or general education degree (GED). A bachelor’s degree with a major in a relevant technical field (STEM) is preferred, but not required.
• EXPERIENCE: 3+ year(s) relevant quality assurance 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 acceptable. 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.

ADP1127

2X9-240227-110

Job Type: Full-time

Pay: $85,000.00 - $95,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

People with a criminal record are encouraged to apply

Experience:

• Plastics injection molding: 1 year (Preferred)
• Quality Assurance: 3 years (Preferred)

Ability to Relocate:

• Phillipsburg, NJ 08865: Relocate before starting work (Required)

Work Location: In person