Site Subject Matter Expert on numerous ISO elements and champion site-wide standardization and continuous improvement initiatives. Has the ability to balance compliance with lean systems to support business.
Apply statistical tools (Minitab, Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, improve process capability, and support lean manufacturing and risk reduction initiatives.
Utilize statistical tools to support the optimization of processes.
Create and ensure project quality planning documentation, required, sampling plan, process controls, early launch activities, monitoring activities to ensure compliance with customer project requirement.
Lead and collaborate cross-functionally with engineering, operations, quality /regulatory affairs, customers and suppliers to address quality related issues.
Ability to manage CAPA Review Board, provide working solutions that meets compliance and business needs & provide summary of issues to senior management.
Lead and mentor Quality Engineers and Technicians, providing technical guidance, developing junior talent, and ensuring effective daily support for production, process improvement, and customer satisfaction.
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.
Known by the site as the go to person to address the specific area.
Ability to use current site knowledge and support other sites helping them to address their site concerns.
Lead supplier quality activities such as supplier selection, qualification, documentation, audits, quality agreement, coordination of supplier-driven product/process changes.
Lead internal and external audits, manage external auditors, oversee internal audit program and report on quality system compliance to site leadership with recommendation for area requiring improvements.
Lead 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.
Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
8+ years’ quality engineering experience in the medical device industry.
Understanding of statistical methods, process control, 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 with formal problem-solving methodologies, critical thinking, and deductive skills.
Advanced understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.
Extensive 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, MDSAP).
Demonstrated ability to lead internal and external audits and inspections effectively, including leading preparations and addressing findings.
Expertise in conducting thorough root cause analyses for complex quality issues and developing effective CAPAs.
Experience with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.
The expected salary range for this position is $95,000 to $115,000 annually, depending on skills, experience, and qualifications.
