Job Description
Stryker is hiring an Associate Manager, Quality Assurance to lead the Quality Assurance team for our Global Quality Organization supporting our Endoscopy/Communications division in Flower Mound, TX that focuses on Quality activities with responsibility for delivering key quality and compliance results for the site operations.
What you will do:
Β Quality Assurance Leadership: Leads the QA team to drive product and process performance, focusing on continuous improvement and alignment with quality assurance programs.
Β 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.
Β Supplier Quality Partnerships: Collaborates with Supplier Quality (SQ) teams to reduce supplier DPM, working toward meeting established quality and compliance targets.
Β Risk and Compliance Management: Supports risk analysis, production control, NC/CAPA activities, and audit readiness to ensure compliance with internal and external quality standards.
Β 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.
Β 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.
Β 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.
Β Quality Improvement Strategy: Develops and implements a quality planning pipeline focused on enhancing product quality, reducing costs, improving efficiency, and strengthening risk management processes.
What you need:
Required:
Β BachelorΒs degree or higher in an engineering-related field.
Β Minimum of 6 years of experience in a highly regulated environment, with a preference for medical device industry experience.
Β At least 2 years of experience in a quality engineering role, with exposure to lean manufacturing principles and continuous improvement practices.
Preferred
Β 1-2 years of experience in people leadership within a highly matrixed environment.
Β Familiarity with ISO standards, including 13485, 14971, and 9001.
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