QMS & Regulatory Compliance Specialist

Responsibilities

• Support the development, implementation, and maintenance of the quality management system (QMS) to ensure regulatory compliance and product quality
• Act as a Quality Systems subject matter expert (SME) to ensure consistent application of requirements across the organization
• Lead data analysis, systems evaluations, and product assessments to identify trends and implement improvements
• Investigate and resolve quality system nonconformances identified through internal and external audits
• Collaborate with product development and manufacturing teams to ensure quality deliverables like FMEA and Risk Management documentation are compliant
• Support compliance with ISO 13485 and 21CFR 820 regulations through gap assessments and remediation activities
• Utilize Six Sigma and other quality tools to implement process improvements and reduce variance
• Lead or participate in cross-functional teams to support quality system initiatives throughout the product lifecycle

Requirements

• Bachelor's Degree in Engineering, a Technical Field, or an equivalent combination of education and experience
• 2-5 years of technical experience, preferably in a Quality role using quality tools and methodologies
• Detailed knowledge of FDA, GMP, and ISO 13485 standards
• Strong project management and leadership skills with the ability to lead multi-departmental teams
• Advanced computer skills, including proficiency in gap analysis and report writing
• Ability to travel approximately 10-25%, including international travel

Preferred Qualifications

• Master's Degree
• Prior experience in the medical device industry
• Six Sigma certification
• ASQ CQE or CQA certification
• Experience working within a broad enterprise or cross-division business unit model

Benefits

• Career development opportunities within an international company
• Eligibility for free medical coverage via the Health Investment Plan (HIP) PPO plan
• Excellent retirement savings plan with high employer contributions
• Tuition reimbursement and specialized education programs including FreeU
• A diverse and inclusive work environment recognized by Fortune

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.