Quality Engineer - Plastic Injection Molding

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Full Time MA STERLING, Lancaster, MA, US

Salary Range: $80,000.00 To $ Annually

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…