Quality Engineer - Plastic Injection Molding

EPTAM Precision is looking for a Quality Engineer, Plastic Injection Molding 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.

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)

PREFERRED CANDIDATE PROFILE

• 3+ years of experience in medical device manufacturing, preferably in injection molding environments
• Deep knowledge of measurement systems, metrology, and capability studies, including CMM programming and advanced gage usage
• Proven experience designing and executing validation protocols (IQ/OQ/PQ)
• Demonstrated ability to present technical findings and quality results to external customers and internal stakeholders
• Strong problem-solving skills with experience in root cause analysis and failure investigations (e.g., 5 Whys, Fishbone, FMEA)
• Comfortable working in cross-functional teams and regulated environments (ISO 13485, 21 CFR 820)

POSITION SUMMARY The Quality Engineer will play a hands-on role in supporting molding operations in a regulated medical device manufacturing environment. This individual must bring strong expertise in quality engineering, measurement systems, metrology, and validation (IQ/OQ/PQ)- from design through execution. The ideal candidate will be confident in leading failure investigations, communicating results to customers, and collaborating closely with cross-functional teams on continuous improvement.

• Execute principles and practices of metrology and measurement, in designing measurement methods/system in NPI into manufacturing and quality control to ensure that products meet design specifications, customer specifications and industry standards through creation of quality planning.
• Analyze process and product data, identify quality issues, and drive systemic improvements, which can involve conducting process capability studies
• Evaluating production processes to ensure they can meet customer requirements and specifications.
• Utilizing statistical methods, like Statistical Process Control (SPC), to analyze data and determine if a process is stable and capable.
• Driving process improvements to reduce variation and enhance product quality.
• Key partner with Operations for designing, executing, and documenting validation activities for equipment, processes, and systems within work cell(s), and write validation reports (IQ/OQ/PQ) for equipment and processes.
• 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.
• Investigate and resolve quality issues (CAPA/Complaints/NCMRs) to meet site procedures, FDA requirements as well as ISO-13485 and AS9100 requirements.
• Perform and support Quality Inspection and Documentation control Specialist duties as needed.

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

• Review new customers orders and specification to identify any changes to existing specification or note new specification and initiate and implement change control under Contract Review.
• Ensuring assignment, processing and execution of identified changes are approved on time (within 2 business days)
• Extremely adapt and super-user of eQMS in relation to document controls, NCMR and CAPA processes.
• Investigate and resolve quality issues through formal root cause analysis and failure investigation techniques, including CAPA, complaints, and NCMRs
• Present quality and validation results clearly and confidently in both internal team settings and external customer audits or meetings.
• Develop and evaluate calibration systems, perform routine maintenance and troubleshooting of measurement equipment, and analyze data to ensure accuracy and consistency. Perform CMM operation and programming
• Ensure Quality Management System documentation and reporting of all Quality-related issues and projects are maintained.
• Identify and support the 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.
• Measure components utilizing advanced measuring equipment (i.e., CMM, vision systems, etc.) and various hand gages such as calipers and micrometers.

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: 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. 1+ year(s) relevant quality assurance experience or training will be accepted with a Master’s degree in Mechanical or Quality Engineering. 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.

O-ADP-1581