Quality Manager, Molding Operations

Job Purpose:Responsible for day-to-day, hands-on, Quality Operations activities required to successfully complete molding and manufacturing activities with focus on compliance, continuous improvement, and resource efficiencies.Duties:Implement and sustain an effective quality management system (QMS) in compliance with ISO 9001 and 13485.Ensure released product meets or exceeds customer expectations, regulatory requirements, and complies with specifications, inspection requirements, standards, policies, contracts, etc.Foster good documentation practices in alignment with data integrity regulations, standards, and record retention policies.Continuously improve via effective root cause analysis, nonconformance management, material review, corrective and preventive action.Resolve customer complaints, feedback, and concerns.Manage audit program (customer, internal, registrar, regulatory body, etc.), always ensuring site readiness.Establish limits for and monitor quality controls, process capability, OEE metrics, feedback, and improvement opportunities for manufacturing and distribution.Collaborate with cross-functional teams to proactively solve issues based on quality data and metrics.Contribute to validation efforts (IQ/OQ/PQ), deviation management, change control, test method and inspection plan effectiveness, and technical report including authorship, review, execution, and/or approval as appropriate.Manage department activities, assignments, oversight responsibilities, and staff.Train, mentor, and coach site personnel as required.Ensure a safe and healthy work environment.Skills/Qualifications:Minimum:Bachelor's degree in a relevant field (e.g., Engineering, Technology, Quality Management etc.).Proven quality assurance experience in the plastic injection molding or related industries.External/internal auditing, training, and leadership experience.Strong knowledge of quality standards, ISO regulations, and best practices.Excellent communication and leadership skills.Ability to analyze data, identify trends, and drive continuous improvementPreferred:Lean Six Sigma certification.CQA, CQE ASQ or related certification.FDA 820 CFRs/ISO 13485/cGMP quality management system experience.Personal Attributes:Meets Gilero Core Values:

Collaboration, Innovation, Excellence, IntegrityProductive in a fast-paced, environment.Commits to excellence and quality service to external and internal customers.Adheres to established policies and procedures, while contributing to continuous improvements.