Sr. Quality Engineer

Sr. Quality EngineerWe are seeking a highly motivated Sr. Quality Engineer to support global quality improvement initiatives across the company's medical device product portfolios. This role will serve as a key Design Quality representative on cross-functional projects focused on quality improvement, cost reduction, operational efficiency, and regulatory compliance.The ideal candidate will bring strong medical device quality experience, expertise in Design Assurance and Design Controls, and the ability to independently lead multiple projects while collaborating effectively with global stakeholders.Key ResponsibilitiesServe as the Quality Lead representative on global quality improvement, cost-down, and efficiency projects.Review, approve, and support design control documentation, qualification activities, protocols, validation deliverables, and quality processes.Ensure products, manufacturing processes, and quality systems remain compliant with applicable regulatory and quality requirements while achieving business objectives.Collaborate with engineering, manufacturing, operations, and cross-functional teams to establish and maintain quality standards.Develop, modify, implement, and maintain quality standards, protocols, and procedures for product and process quality.Support inspection, testing, and evaluation methods to verify product performance and compliance.Conduct quality investigations, root cause analysis, and corrective and preventive action activities as required.Perform risk-based assessments and statistical analysis to evaluate quality performance and drive continuous improvement.Ensure documentation, quality records, and corrective actions meet applicable regulatory and internal requirements.Contribute to Lean, Six Sigma, and continuous improvement initiatives to enhance product quality, efficiency, and cost effectiveness.Minimum Education RequiredBachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.Minimum Experience Required5-7 years of quality engineering experience within the medical device industry.Self-driven leadership with the ability to independently manage multiple projects and collaborate across cross-functional teams.Strong understanding of Design Assurance, Design Controls, and product development processes.Experience supporting regulated medical device products and quality systems.Demonstrated ability to work independently, manage multiple priorities, and influence cross-functional stakeholders.Experience reviewing and approving technical documentation, protocols, and validation deliverables.Strong problem-solving, communication, and project management skills.Preferred QualificationsExperience with Lean Manufacturing, Six Sigma, or continuous improvement methodologies.Knowledge of FDA, ISO 13485, and other applicable medical device regulatory requirements.Experience supporting quality initiatives across multiple product lines or global organizations.Lean Six Sigma Green Belt, Black Belt, or equivalent certification is a plus.ShiftFirst (Day)Number of Openings1Public Transportation AccessibleYesVeterans Encouraged to ApplyYesPhysical RequiredNoDrug Test RequiredYesCompensation$45.00 - $55.00 / HourlyPostal Code55432Job TypeContract (W2)Place of WorkOn-siteRequisition ID6770Job BenefitsHealth Insurance, Life Insurance, 401k retirement plan, paid sick time