Senior Quality Systems Engineer

Primary Function of Position:

This position involves coordinating regulatory compliance activities understanding and mitigating potential noncompliance risks and participating in strategic planning meetings to ensure compliance with global regulatory requirements as well as company policies. This role is responsible for interpreting relevant regulations and implementing practical compliance solutions.

Essential Job Duties:

• 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 noncompliance
• Maintain accurate records of compliance activities and findings
• Understand and provide guidance and training to employees on compliance related matters
• Investigate and resolve compliancerelated 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.

Qualifications :

Required Skills and Experience:

• Minimum 10 years in a quality compliance or regulatory role in the medical device or other regulated manufacturing environment
• At least 5 years of experience managing/leading QMS for a Class III devices
• At least 5 years of experience working with Clinical Regulatory and Organizations on compiling and reviewing PMAs
• Experience hosting and leading PAI (PreApproval Inspection) for PMA
• Responsible to work in office at least 80% of the time.
• Experience as an FDA inspector is a Plus.
• Experience with Technology medical devices products such as robotics software mechanical and electrical is a Plus.
• Ability to understand applicable industry regulations
• Working knowledge of implementing and providing guidance on domestic and international regulations
• Proven organizational written and verbal communication skills

Required Education and Training:

• Minimum Bachelors degree in relevant field

Preferred Skills and Experience:

• 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 compliancerelated 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

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

EEO and AA Policy

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime