Manager, Quality Systems and Auditing - Medical Device
Location: Miami, FL
Working Situation: Onsite
Level: Senior Level
Our client is a global medical device company who is the industry leader of new product development. Our innovative company is actively searching for a new Manager, Quality Systems, for our manufacturing site. The Manager, Quality Systems will be leading our Internal Auditing program by developing and implementing the global Internal Auditing policy and strategies. The successful Manager, Quality Systems will also be leading a team.
The Manager, Quality Systems will be responsible for:
- Lead the QMS Audit Process, ensuring its effectiveness company-wide.
- Foster Internal Audit excellence, promoting collaboration and adherence to standards.
- Enhance digital support systems for Internal Audit processes.
- Ensure compliance with relevant regulations such as FDA and ISO standards.
- Collaborate with Quality Management to address complex quality and compliance issues.
- Train team members and peers on Internal Audit procedures and standards.
- Provide strategic oversight for Internal Audit programs at various sites.
- Develop comprehensive Internal Audit training materials and deliver training sessions.
- Report on Internal Audit metrics and insights to business leaders.
- Manage compliance data pertaining to Internal Audits.
- Offer technical support for Internal Audit problem-solving efforts.
- Present updates on Internal Audit status to regulatory authorities and senior leadership.
The Manager, Quality Systems will have the following qualifications:
- Bachelor's degree in Science, Engineering, or related field
- 6+ years of experience in Quality Assurance
- 3+ years with expertise in QMS auditing, team leadership, and leading transformational changes
- Familiarity with ISO 13485, FDA, and EU regulations
If you are interested in the Manager, Quality Systems opportunity, apply now!
