Quality Engineer

Your Job

Our Clinton, MA location is seeking a Quality Engineer to support manufacturing of injection molded parts and assembly.

Successful candidates will have strong communication skills to collaborate with internal and external teams as well as problem-solving and analytical skills.

Our Team

Phillips-Medisize is a Medical Device Manufacturer that works with Plastic Injection Molding of the parts.

The Maintenance team has four team members and the supervisor.

They are very supportive group of both internal and external customers who enjoy learning and sharing knowledge with each other.

This role has a variety of tasks that offer new challenges and growing opportunities.

What You Will Do



* Responsible for QMS deliverables, including but not limited to: customer complaints, risk analysis, failure mode and effects analysis, CAPA, and process/equipment verification/validation


* Utilize quality tools such as process flowcharting, Pareto analysis, correlation and regression analysis, Design of Experiments (DOE), Gage Repeatability and Reproducibility (Gage R&R), Statistical Process Control (SPC), and trend analysis to address manufacturing quality issues.


* Create and implement required Verification and Validation plans, and develop and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV) for equipment, injection molding, and assembly processes.


* Communicate and coordinate validation activities and approvals, both internally and externally.


* Initiate and review change management requests and deviations.


* Complete the Production Part Approval Process (PPAP) as per the customer requirements.


* Collaborate with engineering, operations, customers, and vendors to meet all quality requirements.


* Assist with customer and third-party quality audits and represent quality in Advanced Quality planning (AQP) meetings.


* Review and approve engineering drawings and manufacturing instructions.


* Author and update work instructions and documents to ensure compliance with ISO 13485:2016 and current Good Manufacturing Practices (cGMP).


* Report product/process performance metrics to management quarterly and support Lean Six Sigma initiatives.


* Acknowledge and adhere to quality agreements and standards set by each customer.


* Develop and implement statistical incoming and in-process sampling/control plans.


* Serve as a communication liaison between customers and the manufacturing facility.

Who You Are (Basic Qualifications)



* Four (4) years or more Quality Engineering experience in a regulated industry


* Bachelor's degree in engineering or science


* Experience in quality management systems, CAPA, and validation processes


* Experience using Minitab


* Experience with ISO 13485:2016


* Experience with SAP or other ERP system

What Will Put You Ahead



* Experience with the injec...