Sr. Quality Process Specialist

Job Summary

Under minimal supervision responsible for independent review of CAPA/investigation content for adequacy and compliance, including comprehensive ability to use critical thinking to evaluate events and the CAPA author team’s responses, root cause analysis, and corrective action planning. Responsible for generating direct feedback to investigation authors and their management structures, as needed, and for working with author teams to produce compliant, complete, comprehensive investigation records that adhere to Medline and industry regulatory requirements and expectations.

Additionally responsible for Quality process design, integration, implementation, and maintenance. Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements. Support Quality Systems related activities, analyzes problems related to quality/regulatory information, and provides systems, and technical support in solving these problems. Support design, development, implementation, and testing of quality solutions and business acquisition integration as required to meet customer/regulatory requirements, and works with internal and external inputs to develop these solutions

Responsibilities:

• Review, advise on, and approve CAPAs and other major investigations as independent reviewer and QMS advisor.
• Provide feedback and drive adherence to investigation content requirements and expectations.
• Administer and maintain quality systems.
• Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures.
• Identifies and advises opportunities to improve quality systems and develop long-term strategies that support the success of the business.
• Determine and create key quality metrics/indicators to track performance and compliance
• Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities.
• Implement and coordinate use of electronic documentation systems and training personnel.
• Collaborate with cross-functional teams to deploy quality processes and systems. Consult and provide guidance to business partners.
• Execute individual responsibilities as CRB team member. Lead CRB team in systems analysis and effectiveness measures.
• Train and coach personnel to deliver optimal results based on the department’s goals.
• Support hosting Notified body/ Registrar Quality Systems audits. Supports in customer and regulatory audits.
• Provide project guidance, training, and coaching.

• Bachelor’s degree in a technical or scientific discipline.
• At least 4 years of experience with medical device or pharma Quality.
• Knowledge of FDA, Quality System Regulations (QSR) and ISO.
• Proficiency in Microsoft Suite, MS Visio, MS Project, Minitab.
• Position requires travel up to 10% of the time for business purposes (within state and out of state).
• Experience with Medical Device and Pharma, multiple product types, and regulatory jurisdictions.
• Experience with quality systems development and implementation.
• Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
• Experience hosting FDA/ISO GMP inspections.
• Experience with SAP.
• Experience with ETQ Reliance.

LI-Hybrid

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$85,000.00 - $ Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please . For roles…