Opportunity for a Quality-Focused Engineer in Medical Manufacturing Our client is currently hiring a Quality Assurance Engineer to join their growing operations in the medical device sector. This full-time role is perfect for a mid-level professional with 3 to 5 years of relevant experience who enjoys collaborating across teams and ensuring excellence in product quality, compliance, and manufacturing support. This position plays a key role in maintaining high standards across the production and product development life cycle ensuring all activities meet applicable regulatory and internal quality standards. What Youll Take Ownership Of: Drive material review activities and help lead weekly meetings focused on nonconformance evaluation and resolution Follow up on vendor quality issues and coordinate disposition efforts Maintain calibration tracking systems to support precision in equipment usage Work closely with manufacturing engineers to develop and update documentation such as build records, process flows, BOMs, and manufacturing instructions Assist with transitioning new products from R&D into production environments Perform component-level reviews for incoming materials to verify conformance Write and update standard operating procedures, inspection criteria, and lab test methods Ensure all documentation and activities align with applicable regulations and company policies Support quality investigations involving customer complaints, internal deviations, and CAPA execution Participate in internal audits and supplier performance evaluations Apply structured problem-solving techniques to assess root causes and support corrective/preventive efforts Use data-driven analysis to recommend and implement risk-based quality decisions Who Were Looking For: 3-6 years of hands-on quality experience in a regulated medical manufacturing environment Solid understanding of FDA 21 CFR Part 820 and ISO 13485 standards Prior experience executing and managing CAPAs Knowledge of validation protocols, including equipment, process, and test method validations (including Gage R&R) Experience with FEMA's and Risk Management Comfortable using Microsoft Office Suite; proficiency in Excel is especially important Working familiarity with statistical analysis tools and methods; Minitab experience is a plus Excellent technical writing skills for protocol development and formal reporting This Role Is a Fit If You: Thrive in a collaborative team environment Can manage multiple priorities with attention to detail Enjoy troubleshooting and using data to guide decisions Are driven to maintain the highest standards in product quality and compliance If you're seeking a role where your input matters, your expertise is valued, and your impact is visible across the organization, we encourage you to apply.