You won’t just maintain quality systems; you’ll actively improve them.________________________________________What you’ll be doing• Develop and improve quality processes that ensure products meet customer and regulatory requirements• Create and maintain documentation such as SOPs, work instructions, control plans, PFMEAs, and inspection reports• Act as the primary point of contact for customer validation activities• Partner with Engineering and Operations to drive IQ/OQ/PQ and/or PPAP validation efforts• Lead root cause investigations and CAPA activities using structured methods like 8D, 5 Whys, and Fishbone• Support inspections, calibrations, audits, and production validations• Monitor process performance, identify issues, and ensure corrective actions are implemented• Analyze quality data and provide insights that drive real improvements• Lead Material Review Board (MRB) activities and manage nonconforming materials• Work cross-functionally to continuously improve processes and reduce defects________________________________________What we’re looking for• 2–4 years of experience in a manufacturing environment• Familiarity with ISO 9001 and/or ISO 13485• Strong problem-solving skills and attention to detail• Experience with measurement and inspection techniques• Comfortable working with data and drawing meaningful conclusions (Minitab is a plus)• Organized, self-driven, and able to manage multiple priorities in a fast-paced environment• Strong communication skills and ability to work across teamsNice to have• Experience with IQ/OQ/PQ or validation processes• ISO auditing experience or certification________________________________________What to expectThis role is a mix of desk work and time on the manufacturing floor. We’re looking for a Quality Engineer who enjoys solving problems, improving processes, and working closely with both engineering and production teams.