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- Toano, VA
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Manager, Regulatory & Quality Compliance
Owens & Minor, Inc. • Toano, VA
Posted 20 days ago
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This position 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.
ESSENTIAL JOB FUNCTIONS:
1. Develops, maintains and manages the Companys Quality system--ensuring that processes needed for the quality management system are effectively established, implemented and maintained.
2. Promotes the awareness of regulatory and customer requirements throughout the organization.
3. Reports to top management on the performance of the quality management system.
4. Responsible for determining if the Quality Management System is suitable and effective
5. Ensures that quality documentation is current and is properly authorized and controlled.
6. Ensures the quality testing and release of manufactured product in a timely fashion. Ensures the release of products comply with applicable internal requirements.
7. Ensures internal, key vendor and product quality audits are completed as prescribed.
8. Ensures Design Transfer is properly completed for product changes and new product implementation.
9. 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.
10. Ensures that all employees are trained in the Companys Quality system, as required.
11. 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.
12. Responsible for ensuring that processes are appropriately validated. Ensures that processes and procedures meet ISO 13485, FDA QSR and other regulatory requirements as well as the Corporate Quality Management System Requirements.
13. 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.
14. 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.
15. 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.
SUPPLEMENTAL JOB FUNCTIONS:
1. Performs additional duties as directed.
EDUCATION & EXPERIENCE REQUIRED:
Bachelors 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, SKILLS & ABILITIES:
Knowledge of FDA regulations.
Knowledge of cGMP regulatory compliance standards.
Knowledge of DEA regulations.
Working knowledge of aspects of distribution, regulatory and legislative environments.
Demonstrated skill in the design, development and interpretation of regulatory action plans.
Ability to independently identify compliance risks and make decisions independently and escalate when necessary.
Proven ability to liaise with Regulatory Agencies having served as lead in.
Excellent verbal communication, presentation, and facilitation skills.
Very strong negotiation, influencing and problem solving skills with the ability to interact effectively with agencies.
Computer Skills proficient with Microsoft Office, other Quality Software tools desired.
Ability to lead and coach others and to work as part of a team.
Customer first focus.
Travel is required (approximately 10%)