Ensure efficient compliance with all applicable global regulatory requirements through the design and execution of a robust quality system. Ensure product safety, reliability, and quality through effective use of quality planning, risk analysis, statistical methods, and process controls across design and manufacturing stages. Support audit readiness and inspection excellence across the product portfolio. Build strong succession pipelines and foster a culture of accountability, collaboration, and continuous improvement. Guide teams through change in a fast‑paced, highly matrixed, global environment. Ensure clear communication and documentation of design quality assurance and compliance information across the division. Work mode: On‑site model, four days per week, in the Arbor Lakes office site. Minimum of a Bachelor's degree Minimum of 15 years of Design Quality engineering experience in a medical device or regulated environment or similar related work experience Minimum of 10 years of direct or indirect management experience Demonstrated ability to lead effectively across a broad set of cross functional partners/teams and diverse body of work/functions/sites in a highly matrixed environment 10% - 20% travel expectations Advanced degree. Experience supporting products that include software or embedded firmware. Proven ability to influence without authority and drive alignment across multiple stakeholders. Track record of applying industry standards and best practices to introduce new perspectives and improvements. High sense of urgency, strong execution focus, and comfort navigating change in dynamic environments.
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