Quality Engineer II

Freudenberg•Beverly, MA

73d

About The Position

Apply quality standards to support the development, qualification, and manufacturing of products to meet internal and external requirements. Apply statistical tools to analyze data, drive acceptance decisions, improve process capability, and support continuous improvement and lean initiatives. Lead Measurement System Analysis (MSA) and supporting product acceptance activities. Support and collaborate cross-functionally with engineering, operations, regulatory, customers, and suppliers to ensure all change-related items are adequately assessed, documented, and tested as required. Create Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, ensure sound start-up of new processes and equipment, and development of all quality-related documentation. Lead resolution of nonconformances, complaints, CAPAs, etc., to resolve quality issues for assigned projects. Support supplier quality activities such as supplier selection, qualification, documentation, audits, etc. Participate in and occasionally lead internal and external audits. Provide guidance to technicians ensuring effective daily support for ongoing tasks. Lead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.

Requirements

Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
3+ years’ experience in Medical Device or a related regulated industry.
Strong verbal and written communication skills with the ability to effectively collaborate across cross-functional teams, including Quality, Engineering, Operations, and customers, to drive problem-solving and continuous improvement initiatives.
Understanding of statistical methods, process control, internal/external audits, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&T and fixturing.
Demonstrated experience in metrology and quality inspection within a manufacturing environment, including Micro-Vu and Keyence measurement systems.
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.
Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States).

Responsibilities

Apply quality standards to support the development, qualification, and manufacturing of products to meet internal and external requirements.
Apply statistical tools to analyze data, drive acceptance decisions, improve process capability, and support continuous improvement and lean initiatives.
Lead Measurement System Analysis (MSA) and supporting product acceptance activities.
Support and collaborate cross-functionally with engineering, operations, regulatory, customers, and suppliers to ensure all change-related items are adequately assessed, documented, and tested as required.
Create Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, ensure sound start-up of new processes and equipment, and development of all quality-related documentation.
Lead resolution of nonconformances, complaints, CAPAs, etc., to resolve quality issues for assigned projects.
Support supplier quality activities such as supplier selection, qualification, documentation, audits, etc.
Participate in and occasionally lead internal and external audits.
Provide guidance to technicians ensuring effective daily support for ongoing tasks.
Lead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.