• 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. (QA in FM COS would not oversee, may participate).
• Participate in and occasionally lead internal and external audit.
• 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.

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.

• 3+ years9 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).

 

Freudenberg Medical LLC