QMS & Regulatory Compliance Specialist

Abbott • Saint Paul, MN

18h • Onsite

About The Position

This position is responsible for supporting the development, implementation, and maintenance of the quality management system to ensure regulatory compliance and product quality. The position provides hands-on quality system support for commercialized products, new product development, manufacturing processes, and overall system compliance.

Requirements

• Bachelors Degree in Engineering or Technical Field or an equivalent combination of education and work experience.
• 2-5 years technical experience.
• Previous Quality experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
• Advanced computer skills, including gap analysis and report writing skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

• Masters Degree.
• Prior medical device experience.
• Six Sigma certification.
• ASQ CQE, CQA certification.
• Experience working in a broader enterprise/cross-division business unit model.

Responsibilities

• Provide day-to-day support as a Quality Systems subject matter expert (SME), to ensure consistent application of QMS requirements across the organization.
• Lead and execute data analysis, systems evaluations, and product assessments to ensure compliance with established standards and specifications; proactively identify trends and implement improvements.
• Investigate, document, and resolve quality system nonconformances identified through internal and external audits, ensuring timely and effective corrective and preventive actions.
• Collaborate with product development and manufacturing teams to ensure quality deliverables (e.g., FMEA, Control Plans, Risk Management documentation) are established and compliant prior to design transfer phase gates.
• Support compliance with applicable regulatory requirements, including ISO 13485 and 21CFR 820 Quality System Regulations by interpretating regulations, conducting gap assessments, and leading remediation and continuous improvement activities.
• Apply structured, risk-based problem-solving methodologies to identify, prioritize, communicate, and resolve quality and compliance issues.
• Utilize continuous as appropriate, utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.
• Analyze audit findings and quality metrics to recommend and implement improvements to processes, systems, and products standards.
• Lead or participate in cross-functional teams to support quality system initiatives, decision-making, and best practices across the product lifecycle.
• Support and/ or lead risk management activities related to quality systems, ensuring ongoing maintenance and compliance with applicable standards.
• Ensure adherence to FDA regulations, global regulatory requirements, company policies, and internal procedures.
• Maintain effective communication and collaboration with internal stakeholders, customers, contractors, and suppliers at all organizational levels.
• Performs additional duties as assigned.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level