Location: Plymouth, MN
Job Summary:
Job Duties and Scopes
- Enforce and harmonize quality systems across global sites.
- Manage compliance with FDA regulations and relevant safety policies.
- Interact with stakeholders to establish and maintain safety risk acceptability.
- Monitor product safety risk management performance and report KPIs.
- Perform quality engineering tasks, including root cause analysis.
- Travel up to 15% annually for business needs.
Required Skills
- Extensive knowledge of QMS and Risk Management in the medical device field.
- Experience with ISO 13485 and ISO 14971 standards.
- Proficient in CAPA processes and conducting audits.
- Strong problem-solving and statistical analysis abilities.
- Ability to influence without authority and ensure accountability.
Required Experiences
- 10+ years of experience in Quality Management and Risk Management.
- Proven leadership in audits and compliance activities.
- Experience adapting quality processes in collaboration with local stakeholders.
- Bachelor's degree in a relevant scientific or engineering field preferred.
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