
Strategic Quality Leader
20 hours ago
Join us as we seek a visionary leader to spearhead our quality assurance efforts. Senior Manager, Quality Assurance is responsible for driving the execution of new product development strategy, ensuring that highly capable processes are developed, resulting in high yield and enabling scalability.
- Key Responsibilities:
- Develop and implement quality strategies to drive business growth and customer satisfaction.
- Cultivate a culture of quality excellence throughout the organization, fostering a collaborative environment where employees feel empowered to identify and address quality issues.
- Lead cross-functional teams to develop and execute process improvements, leveraging tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.
- Maintain up-to-date knowledge of industry trends, regulatory requirements, and emerging technologies, applying this expertise to inform strategic decisions and drive innovation.
- Develop and manage budgets, resource allocation, and project timelines to achieve business objectives.
- Analyze data and metrics to measure performance, identify areas for improvement, and inform decision-making.
- Foster strong relationships with internal stakeholders, including design divisions, advanced operations, and GQO functions, to ensure seamless collaboration and communication.
- Partner with regional NPI QA leaders to share best practices, leverage lessons learned, and drive consistency across the global NPI QA team.
- Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful new product introductions that meet project goals and regulatory requirements.
Qualifications
- Bachelor's degree in Engineering or Science discipline, or equivalent.
- Minimum 10+ years' experience in a regulated manufacturing environment, preferably in medical devices or pharmaceuticals.
- Proven track record of successfully leading cross-functional teams and driving process improvements.
- Expert knowledge of regulatory requirements, standards, and regulations, with experience managing inspections/audits by the FDA and other bodies.
- Demonstrated leadership ability to develop and implement organizational and functional strategy.
- Initiates, sponsors, and implements change with a demonstrated track record.
- Able to work in a team and across all functions, developing organizational relationships and building trust.
- Demonstrated ability to make timely and sound decisions, with a sense of urgency.
- Highly organized and disciplined, able to meet deadlines.
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