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Quality Engineering Manager
BD. Lead a team of quality engineers across the product lifecycle, including NPI, design validation, risk management, process validation, commercialization readiness, product and process transfers, change control, performance monitoring, continuous improvement, and QMS compliance .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading quality engineering teams, managing site validation activities, and ensuring compliance with quality management systems in a regulated manufacturing environment. Proficient in statistical analyses and continuous improvement initiatives to enhance product quality and operational performance.
Highest-signal resume keywords
Quality Assurance LeadershipSite Validation ManagementStatistical Analysis ExpertiseLean Six Sigma CertificationRegulatory Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Statistical AnalysisProcess Capability StudiesDesign of Experiments (DOE)Hypothesis TestingGage R&RRegression AnalysisQuality Management SystemsRisk ManagementCorrective and Preventive Actions (CAPA)Audits
Soft Skills
Team LeadershipProblem SolvingCommunicationContinuous Improvement MindsetCollaboration
Certifications & Qualifications
Bachelor’s Degree in EngineeringASQ-CQE CertificationLean Six Sigma Green Belt Certification
Industry Keywords
Medical DeviceRegulated ManufacturingNon-Conforming ProductsQuality Management Systems (QMS)Product LifecycleChange ControlPerformance MonitoringCommercialization ReadinessDesign ValidationProcess Validation
About the role
Key responsibilities & impact- Lead a team of quality engineers across the product lifecycle, including NPI, design validation, risk management, process validation, commercialization readiness, product and process transfers, change control, performance monitoring, continuous improvement, and QMS compliance
- Ensure proper disposition of non-conforming products through technical review and approval of use-as-is, rework, sort, or scrap decisions
- Plan and coordinate quality engineering activities and resources to meet plant goals and KPIs
- Oversee statistical analyses supporting process development and validation
- Manage the site validation program and Site Validation Lead, including IQ/OQ/PQ activities and revalidations
- Support multidisciplinary functions and approve validation activities
- Monitor plant-floor processes generating quality problems, initiate corrective actions, and follow up on complaints and quality rejections
- Evaluate products returned for alleged non-conformity
- Provide support during internal and external audits
- Prepare and support Management Review meetings and formal quality forums
- Lead continuous improvement initiatives involving inspection technologies, process capability, data reliability, and operational performance
- Lead customer complaints, DHR investigations, product risk documentation, complaint trends, and CAPAs
- Promote a culture of quality and support Business Excellence programs in the Juárez area
- Exercise authority to stop processes causing quality problems and release or retain suspected or defective products or materials
Requirements
What you’ll need- Bachelor’s degree in engineering or equivalent technical degree in sciences (biology, physics, etc.)
- Minimum 5 years of experience in a medical device company or in a high-volume regulated manufacturing environment
- Minimum 5 years of experience in Quality Assurance roles with impact on decision-making and/or in supervision/leadership or other related functions
- ASQ-CQE certification is desirable
- Lean Six Sigma Green Belt certification or higher is desirable
- Mandatory compliance with general and safety procedures applicable to the position
- Ability to lead quality engineers and manage site validation activities
- Knowledge of statistical analyses including process capability studies, Design of Experiments (DOE), hypothesis testing, Gage R&R, and regression analysis
- Experience with quality management systems, regulatory requirements, validation, risk management, CAPA, audits, and customer complaints
Benefits
Comp & perks- Face-to-face collaboration culture
- Learning, growth and development opportunities
- Equal Opportunity Employer