Senior Quality Systems Strategist
4 days ago
We are seeking a highly skilled Senior Quality Systems Strategist to lead the development, implementation, and maintenance of globally standardized Quality Management System (QMS) processes.
Key Responsibilities- Lead the strategic development and implementation of a robust QMS that aligns with regulatory requirements and organizational goals.
- Interpret and apply global regulations and standards, including FDA, ISO, EU MDR, and other relevant quality requirements for medical devices and combination products.
- Collaborate and influence global teams to drive alignment and best practices within the QMS framework.
- Manage and optimize electronic document management systems to ensure compliance and efficiency.
- Foster a culture of continuous improvement by challenging the status quo and implementing innovative solutions.
- Engage with stakeholders across all levels of the organization to promote open communication and collaborative problem-solving.
- Monitor industry trends and regulatory changes to ensure ongoing compliance and readiness.
- Bachelor's degree in a relevant engineering or scientific field.
- Minimum of 10 years in Quality, Regulatory Affairs, Manufacturing, or Engineering roles within regulated industries, specifically medical devices or pharmaceuticals.
- Proven ability to interpret and apply global quality regulations and standards. Significant experience in a manufacturing environment is highly preferred.
- In-depth knowledge of QMS frameworks and best practices.
- Strong strategic thinking skills with the ability to maintain a globally standardized QMS.
- Exceptional leadership, communication, and interpersonal skills.
- Growth mindset with a focus on driving continuous improvement.
- Ability to manage multiple projects and priorities effectively.
- Proficient in relevant PC software applications, including PowerBI.
We offer competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.
CompensationThe estimated salary range for this position is $105-130k annually, with a 7% bonus opportunity.
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