Job Description: Regulatory & Quality Compliance Manager has accountability for Regulatory, Quality and Compliance issues, including state, federal and local regulatory issues, risk management issues, training and development, product compliance, special handling regulations and related information technology requirements. Accomplishes goals through matrix management and oversight of resources and teammates supporting 3PL logics and value-added services for medical device manufacturers.

The anticipated salary for this position is $115,000-$120,000 annually with a 10% AIP eligibility.  The actual compensation offered may vary based on job-related factors such as experience, skills, education, and location. This position is onsite at the Owens & Minor distribution center in Louisville, Kentucky.

Core Responsibilities:

• Develops, maintains and manages the Company’s Quality system--ensuring that processes needed for the quality management system are effectively established, implemented and maintained.

• Promotes the awareness of regulatory and 3PL client requirements throughout the organization.

• Reports to top management on the performance of the quality management system.

• Responsible for determining if the Quality Management System is suitable and effective

• Ensures that quality documentation is current and is properly authorized and controlled.

• Ensures the quality testing and release of manufactured product in a timely fashion. Ensures the release of products comply with applicable internal requirements.

• Ensures internal, key vendor and product quality audits are completed as prescribed.

• Ensures Design Transfer is properly completed for product changes and new product implementation.

• Establishes and maintains an adequate organizational structure with sufficient personnel to ensure conformance with quality systems requirements. Manages personnel activities including hiring, training, development and performance management

• Ensures that all employees are trained in the Company’s Quality system, as required.

• Represents the site for all audits conducted by the FDA, notified bodies, partner companies and corporate audits. Acts as the quality management representative on behalf of the facility.

• Responsible for ensuring that processes are appropriately validated. Ensures that processes and procedures meet ISO 13485, ISO 9001, FDA QSR and other regulatory requirements as well as the Corporate Quality Management System Requirements.

• Provides direction and coordination of efforts of the Quality Assurance Resources to ensure overall effectiveness in Quality Assurance support of the manufacturing departments and to proactively identify and execute quality improvement programs.

• Supports the EHS policy. Complies with all local EHS legislation and codes. Identifies reports, investigates and addresses any EHS substandard acts and/or conditions. Drives the setting of EHS objectives and evaluate the effectiveness of the EHS Management System.

• Contributes to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve results.

Qualifying Experience:

• Bachelor’s degree required, in engineering or other science-related disciplinary area.

• Minimum, seven (7) years of experience in a QSR (GMP) manufacturing environment involving the regulations, standards, development, assembly and packaging of medical device hardware and/or software, supply chain strategies, operations, project management or an equivalent combination of education and experience, required.

• Minimum, two (2) years of supervisory experience, required.

• Knowledge of FDA regulations.

• Knowledge of cGMP regulatory compliance standards.

• Knowledge of DEA and human tissue regulations a plus

• Working knowledge of aspects of distribution, regulatory and legislative environments.

• Demonstrated skill in the design, development and interpretation of regulatory action plans.

• Proven ability to liaise with Regulatory Agencies, having served as lead in conversations.

• Proficient in Microsoft products such as Word, Excel, PowerPoint, and Outlook

• Travel is required (approximately 25 - 40%)

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If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.