Quality Assurance Manager - Military veterans preferred

Job Summary:

The Quality Manager is responsible for building, leading and continually improving the quality assurance, quality control & regulatory structure and team to support brand protection/risk identification and reduction activities, improve process efficiency/cost containment and to support sales and operational activities throughout the manufacturing site(s). This position uses data-driven-decision making, quality principles, tools and key metrics to drive culture of quality (CoQ) and results-oriented improvements throughout the organization.

Position Objective:

This position leads and develops direct reports and cross-functional team members where applicable. The Manager combines expertise in quality management principles, tools, and techniques with high levels of business acumen to develop people, processes, and associated metrics for the improvement of the business. This position is responsible for the improvement and maintenance of the quality management system (QMS). Additionally, this position is responsible for overseeing and managing the quality assurance and quality control programs across two NC sites, which include implementing quality procedures and training, ensuring successful audits and certifications from regulatory bodies, managing site data integrity and stability programs, and overseeing the onsite laboratory. The Quality Manager will also play a key role in responding to customer complaints and coordinating with site operations and commercial teams to address issues and implement corrective actions.

Essential Job Responsibilities:

• Develop, implement, and maintain quality procedures and systems (electronic and manual) to ensure compliance with regulatory requirements and industry standards.
• Maintain and audit calendar and conduct regular audits to ensure compliance with quality standards.
• Ensure successful completion of audits and certifications by regulatory bodies.
• Manage the day to day onsite quality processes including incoming receipt and inspection, batch record management and issuance, label issuance, batch record review, supplier management, etc
• Communicate corrective action plans (CAPAs) to relevant stakeholders and ensure their implementation.
• Develop and maintain record systems for quality performance metrics, including global quality metrics.
• Provide oversight of the quality control laboratories including testing methodology, qualifications, stability and data integrity management and maintaining laboratory documentation to meet requirements.
• Work with cross functional teams to identify areas for improvement and implement processes to enhance quality.
• Stay up to date with industry developments and regulatory requirements and provide recommendations for continuous improvement of the quality program.
• Leads, develops, and continually upgrades skills and abilities of team.
• Promulgates culture of quality throughout the organization through interactions, teaching and by example.
• Accountable for risk identification and mitigation/brand protection.
• Supports sales and operational directives.
• Demonstrates both a process approach and data driven decision making/metric skills to improve company performance systematically and objectively.
• Actively manages the QMS to balance gain/capture of improvements with agility and lack of bureaucracy and waste.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Qualifications:

• Bachelor of Science or equivalent degree program in Engineering or other STEM field of study
• 8+ years’ experience in Quality Assurance/Quality Control in a regulated industry and 5 years’ experience specific to management responsibility.
• Proven successful ability in the following areas:
  1. Customer satisfaction/delight
  2. Leadership of direct reports and cross-functionally
  3. Influence without Authority
  4. Internal relationship-building cross-functionally
  5. Attention to detail
  6. Technical / Professional / Industry Knowledge
  7. Communications (written and oral both internal and with customer interfaces)
  8. Data-Decision Making and Ownership
  9. Development of systems, processes and metrics
  10. Initiating Action
  11. Contributing to Team Success
  12. Follow-up and Closure
• Demonstrates excellent written and oral communications
• Must have professional demeanor; ability to use appropriate levels of tact, diplomacy, and discretion
• Demonstrated strong time management skills; able to handle multiple tasks, set priorities and meet deadlines
• Ability to resolve conflicts; work well under pressure, act quickly and decisively using sound judgment

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to wet (non-weather); fumes or airborne particles; toxic or caustic chemicals. The employee is frequently exposed to work near moving mechanical, pneumatic, hydraulic, or pressurized parts. The noise level in the work environment is usually moderate.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee is regularly required to stand. The employee is frequently required to walk; use hands to finger, handle or feel and reach with hands and arms. The employee is regularly required to sit. The employee regularly lifts and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include Close vision, Color vision, Peripheral vision and Depth perception.

As an Equal Opportunity Employer, ILC Dover is committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.

Background Check & Drug Screening Required

E-Verify Used

EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran