Supervisor, Quality Compliance

What Quality Systems contributes to Cardinal Health

Quality Systems ensures the integrity compliance and continuous improvement of Cardinal Healths Quality Management System (QMS) across manufacturing and distribution operations. This function plays a critical role in maintaining product quality patient safety and regulatory compliance by managing core quality processes such as CAPA nonconformance handling change control document control and audit readiness.

Quality Systems partners cross-functionally with Operations Regulatory Affairs and Supply Chain to ensure all products meet applicable regulatory requirements (FDA ISO MDSAP) and are released in a timely and compliant manner. Additionally the function drives continuous improvement initiatives supports regulatory inspections and ensures effective responses to internal and external audit observations.

Responsibilities

• Leads and maintains the site Quality Management System (QMS) to ensure compliance with FDA (21 CFR Part 820) ISO 13485 and other applicable regulations

• Manages CAPA processes including investigations root cause analysis corrective actions and effectiveness checks

• Oversees Nonconformance Reports (NCRs) ensuring proper documentation investigation and timely resolution

• Ensures effective execution of Change Control and Document Control processes

• Oversees product release activities and ensures compliance prior to distribution

• Manages product holds including investigations and coordination of product detentions in Distribution Centers (DCs)

• Serves as a key contact during regulatory inspections including FDA interactions and product reviews

• Leads and supports internal external and customer audits ensuring audit readiness and timely closure of findings

• Ensures compliance with training requirements and monitors training effectiveness for regulated activities

• Oversees calibration programs and supports environmental and process control requirements

• Coordinates and supports customer technical visits and quality-related inquiries

• Supervises coaches and develops Quality Technicians ensuring team performance and engagement

• Drives continuous improvement initiatives using quality data metrics and trend analysis

• Supports Management Review processes and execution of related action plans

Qualifications

• Bachelors degree in Engineering Life Sciences or related field preferred

• 35 years of experience in the medical device industry with strong focus on Quality Systems preferred

• Minimum 2 years of leadership or supervisory experience preferred

• Strong knowledge of FDA regulations (21 CFR Part 820) ISO 13485 and MDSAP preferred

• Experience with CAPA NCRs Change Control audits and product release processes preferred

• Experience in sterile and/or non-sterile manufacturing environments preferred

• Strong root cause analysis and problem-solving skills preferred

• Ability to work cross-functionally and communicate effectively with internal and external stakeholders preferred

• Proficiency in Microsoft Office applications preferred

• Advanced English communication skills (written and verbal) and Spanish (advanced) preferred

What is expected of you and others at this level

• Applies working knowledge of quality systems and regulatory requirements to manage day-to-day operations and solve moderately complex problems

• Leads a small team providing direction coaching and performance feedback to ensure alignment with organizational goals

• Exercises judgment within defined procedures and practices to determine appropriate actions

• Collaborates cross-functionally to ensure quality and compliance objectives are met

• Supports and drives continuous improvement initiatives within the quality system

• Ensures adherence to policies procedures and regulatory requirements escalating issues as needed

• Communicates effectively with internal teams and external stakeholders including auditors and customers

• Demonstrates accountability attention to detail and a strong compliance mindset Contributes to building a positive quality-focused culture within the organization

Anticipated salary range:$70400 - $90450

Bonus eligible:No

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical dental and vision coverage

• Paid time off plan

• Health savings account (HSA)

• 401k savings plan

• Access to wages before pay day with myFlexPay

• Flexible spending accounts (FSAs)

• Short- and long-term disability coverage

• Work-Life resources

• Paid parental leave

• Healthy lifestyle programs

Application window anticipated to close:8/21/2026 *if interested in opportunity please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including but not limited to a candidates geographical location relevant education experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work people with disabilities without a college degree and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin ancestry age physical or mental disability sex sexual orientation gender identity/expression pregnancy veteran status marital status creed status with regard to public assistance genetic status or any other status protected by federal state or local law.

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