About Intelliguard:
Intelliguard protects patients and hospitals by creating a continuously improving environment of safety around every medication decision through an advanced data platform, interoperable software architecture, and RFID-powered station and cabinets. Ours is a global, data-first company that delivers clinical, supply chain, and regulatory solutions to ensure safety and positive outcomes from supplier to patient.
We continue to expand our product lines and deploy groundbreaking solutions that enable safety across the healthcare supply chain. Join our team of engineers, developers, pharmacy professionals, quality control experts, and commercial team associates as we drive toward breakthroughs every day.
Ours is a history we’re proud of. And our future is one we look forward to. Come join us!
About The Role:
Intelliguard has an excellent opportunity for a Quality Manager to join our team in Columbus, Ohio reporting to the Senior Director of Operations. As a Quality Manager you will be responsible for working with in-house and contracted design teams, and our contract manufactures. This position shall be knowledgeable in Root Cause Analysis, Risk Analysis, writing test plans, documentation review and process improvement. This position provides leadership for the Quality department and executive team to ensure the successful development, implementation, and maintenance of all quality systems and functions, and assists in regulatory processes.
What You'll Be Doing:
- Serve as the primary Quality Management Representative for the company, representing the Quality Management System (QMS) internally and externally.
- Develop and implement quality procedures in collaboration with the operations and product development teams.
- Understand customer requirements to design and maintain effective quality processes that meet or exceed expectations.
- Oversee all aspects of Product Quality, Supplier Quality, and Contract Manufacturer Quality
- Support site investigations and ensure timely and effective completion of corrective and preventive actions (CAPAs).
- Prepare, maintain, and improve site QMS documentation, including SOPs, forms, equipment lists, calibration schedules, and other technical documents.
- Participate in internal and external audits to ensure accurate representation of quality systems and areas of responsibility.
- Implement in-process inspection and testing protocols based on manufacturing processes and quality risk assessments.
- Define standards and procedures for finished product evaluation and disposition through appropriate testing and inspection methods.
- Collaborate with cross-functional teams to support the development of new products, engineering designs, manufacturing processes, and training initiatives.
- Generate and maintain quality reports by collecting, analyzing, and summarizing product and process performance data and trends.
- Support or lead regulatory activities, including handling inquiries from regulatory agencies, preparing product registrations/submissions, and maintaining device listings and regulatory compliance documentation.
- Manage Document Control, ensuring effective control of QA documentation and maintaining the QA document archive.
- Lead validation and verification activities, ensuring compliance with applicable standards and company requirements.
- Manage the identification, investigation, and disposition of non-conforming materials and products.
- Coordinate and facilitate Management Review Meetings, providing updates on compliance metrics, QA initiatives, nonconformances, customer complaints, and supplier performance.
- Act as the Subject Matter Expert (SME) for Quality Assurance during regulatory audits and inspections (e.g., ISO audits, Notified Body inspections).
- Perform other duties as assigned in support of the Quality and Company objectives.
We Would Love To Hear From You, If:
- Bachelor’s degree in engineering, Quality, Life Sciences, or a related field (or equivalent experience).
- Must have experience in implementing new Quality Management Systems.
- At least 5 years of Quality Management experience in a regulated environment such as ISO 9001. (Preferred)
- Demonstrated expertise in designing, developing, and implementing Quality Management Systems (QMS) from inception, with a track record of successful deployment in divers operational environments.
- CQE and CMQ Trained/certification from an independent organization. (ASQ)
- Solid problem solving, organizational, analytical, and critical thinking skills.
- Demonstrates the ability to understand, interpret, and use statistical data and techniques.
- Excellent prioritization skills and multitasking.
- Direct leadership experience with a team of 2-5 direct reports.
- High level of initiative and self-motivation with a strong sense of urgency and accountability.
Why You Should Join Us:
- Generous Paid Time Off (Vacation, Sick, 10 Holidays, Floating Holiday Time)
- Medical, Dental, Vision Plans
- 401K with Employer Match
- Life/AD&D and Long-Term Disability (LTD)
- Flexible Spending Account (FSA)
- Voluntary Life/AD&D Optional Plans
- Pet Plan
- Parental Leave
- To play a part in helping hospitals and health systems continuously improve the environment of safety around every medication decision!
Other Information:
- Onsite role in Columbus, OH
- The essential functions of the job are usually performed in an office setting, in an indoor, temperature-controlled environment. The office environment noise level in the work environment is typically low to moderate. While performing the job duties, the employee is regularly required to sit for extended periods, standing and walking intermittently, reach with hands, arms, talk or hear. The employee is required to use office equipment such as a computer, mouse, keyboard, printer
- The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and the ability to adjust focus.
- We are committed to providing equal employment opportunities to all qualified individuals. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of the job, we will work with you to provide an appropriate accommodation in accordance with applicable laws.
- *Relocation assistance is NOT available for this role.
The pay range for this role is:
90,000 - 125,000 USD per year (Columbus, OH Office)
