Senior Quality Engineer

The Senior Quality Engineer is responsible for providing technical quality support to ensure customer, regulatory, and internal requirements are clearly understood and effectively implemented. This role works cross-functionally with engineering, operations, supply chain, and quality teams to support qualification, validation, and manufacturing readiness activities.The position plays a key role in nonconformance management, supplier quality, complaint handling, and corrective and preventive action (CAPA) processes. In addition, the Senior Quality Engineer provides leadership and oversight to inspection and quality control functions to ensure consistent, high-level performance and product quality.Work Location / Schedule This role is primarily onsite at a manufacturing facility and may require occasional travel to other operational locations. Relocation assistance is not provided.Key Responsibilities Support and/or lead qualification activities required for manufacturing process releaseSupport and/or contribute to process validation activities associated with manufacturing transfersPartner with manufacturing and engineering teams to drive effective nonconformance investigation and resolutionLead or support customer complaint handling and related CAPA activitiesSupport purchasing and receiving inspection activities to ensure raw material accuracy and timelinessSupport development and transition of manufacturing processes and controlled documentation from prototype through commercial productionPromote adherence to Quality Management System (QMS), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP)Contribute to and support the internal audit programParticipate in supplier, customer, and external audits as neededLead and direct quality inspection teams to ensure high product quality and throughputSupport production floor quality objectives, including in-line inspection, lean initiatives, and scrap reductionPerform other duties as assignedRequired Qualifications 5–8 years of experience in a regulated medical device manufacturing environment (ISO/FDA)Bachelor's degree in Engineering, Science, Manufacturing, or equivalent relevant experienceExperience with root-cause analysis, process and equipment qualification, validation, metrology, automation, and auditingStrong communication skills, collaborative mindset, and confidence working cross-functionallyProficiency with common business and quality software toolsAbility to sit or stand for extended periodsPreferred Qualifications Experience with Class II or Class III medical devicesBackground in contract manufacturing and extrusion processesCompensation and Benefits Competitive salary based on experience, education, and market factorsEligibility for an annual performance-based bonusComprehensive benefits package, including medical, dental, vision, disability coverage, and supplemental insurance optionsHealth savings account with employer contributionPaid time off, paid holidays, and sick leaveParental leaveRetirement savings plan with employer matchOpportunities for professional development and career advancement#J-18808-Ljbffr