Quality Assurance Manager

Stryker is hiring a Manager, Quality Assurance to lead our Quality Assurance team within the Global Quality Organization, supporting the Endoscopy/Communications division in Flower Mound, TX! This role focuses on overseeing quality activities and ensuring the delivery of key quality and compliance outcomes for site operations.

What you will do:

• Quality Assurance Leadership: Leads a high performing QA team to drive product and process performance, focusing on continuous improvement and alignment with quality assurance programs.

• Performance and Compliance Initiatives: Implements programs to achieve product performance targets, reducing defects in areas like first pass yields, process defects per million (DPM), and manufacturing losses.

• Supplier Quality Partnerships: Collaborates with Supplier Quality (SQ) teams to reduce supplier DPM, working toward meeting established quality and compliance targets.

• Risk and Compliance Management: Supports risk analysis, production control, NC/CAPA activities, and audit readiness to ensure compliance with internal and external quality standards.

• KPI Management and Trend Analysis: Oversees the adherence to quality performance KPIs, taking timely actions to address adverse trends or deviations, and actively participates in global forums to identify improvement opportunities.

• Customer and Regulatory Conformance: Ensures that products meet or exceed customer requirements and comply with relevant regulatory standards, with an emphasis on proactive quality management and corrective actions.

• Continuous Improvement and Accountability: Promotes a culture of quality ownership across the organization, encouraging employees to prioritize quality in their roles and fostering an environment of continuous improvement.

• Talent Development and Team Building: Builds a high-performing QA team, emphasizing talent selection, training, performance management, and a positive work environment based on inclusiveness, trust, and teamwork.

• Quality Improvement Strategy: Develops and implements a quality planning pipeline focused on enhancing product quality, reducing costs, improving efficiency, and strengthening risk management processes.

• Global Collaboration and Process Improvement: Foster strong collaboration on a global scale by participating in and leading cross functional and global process improvement initiatives.

• Regulatory Certification and Audit Leadership: Ensures the site(s) maintains continued certification to all regulatory bodies. Plays a lead role in all internal and external audit programs such as Corporate, notified body & FDA audits.

• Management of Product/Process Deviations: Oversees the control and management of product and process deviations, ensuring timely corrective actions are implemented for non-conformances and managing product and patient risk.

• Strategic Global Alignment and Benchmarking: Identifies opportunities for global alignment and develops strategies to implement best-in-class practices, benchmarking Stryker’s processes against industry leaders and regulatory requirements to ensure top-tier quality management.

What you need:

Required:

• BS of Engineering, Science or equivalent related qualification.

• 8+ years of experience in Quality Assurance, Manufacturing, Engineering, or relevant experience.

• Regulated industry required. Preferably Medical Device or Pharma.

Preferred:

• 3+ years of people management experience, with success building and leading high-performing teams.

• Ability to implement organizational strategy and drive change effectively at both individual and team levels.

• Strong communication, project management, and leadership skills, with the ability to manage multiple projects and meet deadlines.

• Self-starter with excellent analytical, problem-solving skills, and the ability to work efficiently in a fast-paced environment.

• Knowledge of regulatory requirements and experience managing FDA and other audits/inspections.

• Proficient in quality tools (e.g., SPC, FMEA, Root Cause Analysis, Poka-Yoke, Six Sigma).

• Familiarity with ISO standards, including 13485, 14971, and 9001.