Staff Quality Systems Engineer

Minimum 12 years in a quality, compliance, or regulatory role in the medical device or other regulated manufacturing environment
Ability to understand applicable industry regulations
Working knowledge of implementing and providing guidance on domestic and international regulations
Strong organizational, written and verbal communication skills
Bachelor’s degree in relevant field

Develop and implement comprehensive compliance programs and policies
Conduct regular audits and assessments to ensure adherence to regulatory requirements and internal controls
Maintain compliance with global regulatory requirements
Proactively identify and strategize ways to mitigate risks of non-compliance
Maintain accurate records of compliance activities and findings
Provide guidance and training to employees on compliance related matters
Investigate and resolve compliance-related issues, including potential violations
Stay informed about industry best practices and emerging compliance trends
Prepare and submit reports on compliance activities
Collaborate with cross functional teams to integration compliance requirements in other processes
Other duties as required.

Experience conducting research, analyzing information and data, and presenting findings in a clear and concise format
Knowledge of applicable laws, regulations, and statutes related to employment, benefits, and HR compliance globally
Experience designing and administering scalable compliance-related processes and programs
Experience working directly with agencies like FDA, Notified Bodies, or others, as applicable
Knowledge of validation methodologies pertaining to computer system, process, and equipment preferred
Six Sigma Greenbelt certification or other professional certification (e.g., ASQ certification)
Solid judgment abilities and skills
Ability to engage in constructive dialogue