Job Description

Cordica Medical is a mission‑driven medical device company dedicated to advancing patient care through thoughtful innovation and clinical excellence. We specialize in developing and commercializing technologies that address meaningful unmet needs, with a focus on improving outcomes, efficiency, and quality of life for patients and providers alike.

Our team brings together experienced professionals from clinical, engineering, regulatory, and operational backgrounds who share a commitment to integrity, collaboration, and impact. At Cordica Medical, every role contributes directly to our purpose—translating smart ideas into practical solutions that make a real difference in healthcare.

If you’re looking to grow your career in an environment that values accountability, curiosity, and teamwork, Cordica Medical offers the opportunity to do meaningful work while helping shape the future of medical technology.

We are seeking a Quality Manager to join our Morristown, Tennessee manufacturing team. The successful candidate is responsible for maintaining an effective Quality Management System in accordance with FDA Regulations (Medical Device regulations - 21 CFR 820 and/or Pharmaceuticals 21 CFR 210-211) and ISO standards (ISO 13485:2016, ISO 9001:2015) as it pertains to Manufacturing, Engineering, Purchasing, and Customer Service. Supervise, train and assist personnel with inspections, complaint resolutions, documentation control, GMP compliance, risk analysis/mitigation, and product conformity. They are also responsible for working independently, monitoring KPI’s and implementing action plans for Continuous Improvement and Regulatory compliance.

Specific Duties:

• Ensures products are manufactured/packaged in accordance with FDA requirements, ISO standards, Customer Requirements and Supplier Quality Agreements.
• Review/resolve quality problems by leading Root Cause Analysis (RCA), determining Corrective Actions Preventative Actions (CAPA) and Verifying implementation.
• Manages Quality Laboratory and ensures testing is performed in support of QMS, regulations and business needs
• Ensures adherence to Standard Operating Procedures and Work Instructions
• Creates/updates procedures, work instructions and forms
• Dispositioning non-conforming product and customer returns
• Performs audits of sister sites and other departmental areas
• Trending and reporting complaints, non-conformances and manufacturing data related to nonconforming product and waste
• Reporting KPI’s and implementing processes to ensure KPI targets are met
• Leads Customer and third-party audits at respected plant
• Performs Mock Recalls
• Create/provide training for plant personnel
• Prepares reports and other documentation required by regulatory agencies and the head of quality
• Maintain Change Management program, performing risk analysis and ensuring changes are documented and approved
• Oversee Pest Management program
• Maintain Quality records both electronically and in hard copy, as required
• Perform/Assist with Machine Qualifications (IQ/OQ/PQ) and Process Validations
• Maintain nonconformance log and associated trending and charting
• Maintains a positive attitude and acts as cultural change agent
• Demonstrated ability to work independently with limited direction
• Address personnel issues, enlisting assistance as needed or required
• Make recommendations on employment decisions (e.g., hiring, disciplinary action, termination)
• Effectively communicate at all levels
• Maintain good attendance
• Perform other duties as assigned by the Sr. Quality Manager or Quality Director

Qualifications / Skills Required:

• Experience in a GMP regulated environment (Medical Device, Pharmaceutical, Cosmetic, Food or the Packaging thereof)
• Experience leading Root Cause Analysis/Investigations
• Ability to lead and coach various quality, improvement and investigational tools (e.g. 5 why’s, Process Mapping, FMEA, Control Plans, Fishbone, Lean Six Sigma, 8D, etc.)
• Experience or practical training in statistical process control
• Excellent communication skills, working with internal and external customers, suppliers, and auditors
• High proficiency in Microsoft Office suite (Excel, Word, PowerPoint)

Education / Experience:

• Bachelor's degree in Chemistry, Biology, related science or Engineering discipline
• Three years’ experience managing Quality Management Systems
• Proven record of performance to job requirements
• Experience with FDA audits, regulatory agency interaction, and/or ISO certification processes
• ASQ Certifications (e.g. LSSGB, CIA, CQA, CQM, etc.) - preferred

Cordica Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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