Staff Quality System Engineer
Primary Function of Position
Principal-level professional individual contributor leading enterprise-wide or global compliance initiatives. Drives policy, major risk assessments, remediation projects, compliance strategy, audit response, training programs, technology adoption, and business integration activities. Represents the organization in regulatory, client, industry, or executive interactions.
Qualifications
Minimum 12 years of compliance, quality systems, or regulatory program experience, or equivalent combination of education and experience.
Deep expertise in global or regional regulations and quality system requirements relevant to the business.
Demonstrated experience leading enterprise or global compliance programs, major risk assessments, remediation projects, audit responses, investigations, and cross-functional initiatives.
Mastery in strategic planning, policy writing, enterprise risk management, audit management, and regulatory interface activities.
Strong executive communication, training, talent development, change leadership, and program management capabilities.
Ability to influence senior leaders and represent the company in regulatory, client, or industry interactions.
Required Education And Training
Bachelor’s degree in a relevant field, or equivalent combination of education and experience.
Advanced degree preferred.
Training or certification in quality systems, auditing, enterprise risk management, regulatory compliance, project management, change leadership, or compliance program management preferred.
Working Conditions
Office or hybrid work environment.
Frequent interaction with executives, process owners, auditors, regulators, clients, industry representatives, and cross-functional teams.
Work may involve high-priority compliance issues, regulatory inspections, major remediation programs, and complex implementation schedules.
Requires the ability to support global teams, business needs, and time-sensitive compliance commitments across time zones.
Domestic and international travel required.
Preferred Skills And Experience
Experience leading enterprise QMS programs, global compliance harmonization, regulatory remediation, Class II or Class III medical device compliance, IVD or IVDR, post-merger integration, digital compliance transformation, regulatory agency interactions, and executive governance forums.
Advanced certifications such as ASQ CQA, CQE, CMQ/OE, RAC, Lean Six Sigma Black Belt, PMP, or enterprise risk management certification preferred.
Experience influencing executive leadership and representing the company externally preferred.