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.
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.