Engineer II, Quality

Changing lives. Building Careers.   Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Summary Description The Quality Engineer II (QE II) is responsible for independently supporting manufacturing and engineering operations to ensure the manufacture of safe, compliant, and high‑quality medical devices. This role maintains and improves quality system effectiveness through ownership of investigations, CAPAs, risk management activities, and validation support, while ensuring compliance with applicable regulatory requirements and corporate policies. The QE II operates with general supervision and increased technical depth compared to entry‑level Quality Engineers Job Description Ensure compliance with cGMP, FDA QSR, ISO 13485, ISO 9001, MDR/CMDR (as applicable), and internal Quality Management System procedures Independently own and close investigations, nonconformances, and CAPAs of moderate complexity, including root cause analysis and effectiveness checks Assist or lead nonconforming product activities, including investigations and coordination/management of MRB review and approval Review and approve quality records within established authority, including deviations, change controls, validation documentation, and risk management records Lead or support process, test method, and equipment validation activities, including protocol execution and report approval Execute and lead pFMEA and risk management activities in support of manufacturing and process changes, including pFMEA developments and updates Provide quality engineering support to manufacturing operations, including disposition of nonconforming material and process issue resolution Support new product introductions (NPI) and transfer activities as the Quality Engineering representative Work with project teams to develop DOEs and statistically sound tests for appropriate support of results. Apply statistical and risk‑based tools such as SPC, sampling plans, and data trending to identify and drive process improvements Participate in internal/external audits, supplier audits, and regulatory inspections (FDA, ISO), including preparation and response support Assist of lead customer complaint investigations and post‑market surveillance activities, as assigned. Collaborate cross‑functionally with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, and Operations Prepare quality data and metrics to support management review and continuous improvement initiatives Support corporate Regulatory Affairs by providing information for submissions and Annual Reports. Identify and implement opportunities for continuous improvement. Position is based on-site Required Qualifications Bachelor's degree in Engineering (Biomedical, Mechanical, Chemical, Electrical) or a Life Science discipline (Biology, Chemistry) or related technical field. Minimum 3 years of Quality Engineering experience in a regulated manufacturing environment (or 1-2 years with a Master's degree). Medical device industry experience. Experience applying FDA and ISO quality standards within a regulated medical device environment. Experience in Quality Engineering, Quality Assurance, or Quality Compliance within a regulated industry. Working knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, ISO 9001, cGMP, and risk management principles (ISO 14971). Experience owning and managing nonconformances, investigations, CAPAs, and nonconforming product processes. Experience supporting change control activities and process, test method, and equipment validations. Ability to analyze process and quality data, identify trends, and recommend improvements. Knowledge of statistical sampling and