Quality Assurance Director- Healthcare jobs in Nevada

WHO WE ARE

For over 40 years, ProCaps Laboratories has understood that people are becoming more mindful of what they put into their bodies to improve their health. From its inception, the company’s goal has always been to manufacture and market the world’s most effective supplements, and to do so with the highest integrity, and in the most environmentally friendly way.

ProCaps Laboratories, founded in 1979 by Andrew Lessman, who remains the sole shareholder and CEO, has led the industry in research, development, and innovation, continuously advancing product formulations based on cutting-edge nutritional science and progressing technology. This unique company remains one of the few that actually develops and manufactures each of its products in its state-of-the-art, 100% solar-powered, zero carbon footprint, eco-friendly, award-winning facility.

Located in Henderson, Nevada, near the exciting and diverse community of Las Vegas, ProCaps Laboratories is a large and rapidly growing manufacturer with approximately 350 employees that markets several hundred dietary supplement SKUs, along with an expanding line of functional foods (bars, packets, bottles, etc.)

POSITION SUMMARY

As the Director of Quality, you will be responsible for directing excellence in quality during the production cycle by providing technical leadership within the quality discipline, driving adherence to established standard operating procedures. You will lead the Quality Assurance/Food Safety and Quality Control teams. Additional duties will be to work directly with internal departments, suppliers, and various agencies to effectively resolve problems and must be able to drive continuous improvement in the facility.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Quality Strategy and Leadership:

• Direct departmental operations for Quality Assurance, Quality Control, and Document Control
• Develop and implement a comprehensive food safety and quality strategy aligned with organizational goals and industry best practices.
• Provide strategic leadership to drive a culture of food safety and quality excellence throughout the organization.
• Establish quality policies, procedures, and standards to ensure compliance with regulatory requirements.
• Manage internal auditing of all applicable departments and submit reports to senior management.

Quality Management Systems:

• Oversee the development, implementation, and maintenance of robust food safety and quality management systems.
• Drive continuous improvement initiatives to enhance quality processes, product reliability, and customer satisfaction.
• Champion the use of quality tools and methodologies such as Six Sigma, Lean, and Statistical Process Control (SPC).
• Ensures all departments develop appropriate quality-related processes, standard operating procedures (SOPs), training materials, and documentation to ensure compliance with all federal regulations for the dietary supplement industry.

Supplier Quality Management:

• Collaborate with supply chain and procurement teams to establish and maintain robust supplier quality management processes.
• Conduct supplier audits, assess performance, and drive continuous improvement across the supply chain.
• Develop and nurture strong relationships with key suppliers to ensure high-quality inputs and components.

Customer Focus and Complaint Resolution:

• Lead customer-focused quality initiatives, ensuring timely and effective resolution of customer complaints and issues.
• Develop and maintain effective communication channels with customers to proactively address quality concerns.
• Implement customer feedback mechanisms and use insights to drive product and process improvements.
• Leads and/or supports investigations through effective Corrective Actions and Preventive Actions (CAPA) processes.

Quality Metrics and Reporting:

• Define and track key quality performance indicators (KPIs) to monitor the effectiveness of quality systems and processes.
• Prepare regular quality reports for senior management, highlighting trends, areas of improvement, and actionable insights.
• Utilize data analytics to drive informed decision-making and continuous improvement efforts.

Regulatory Compliance:

• Ensures required cGMP training for both new and existing staff is implemented as it relates to Title 21 Code of Federal Regulations, Part 110, 111 & 117 requirements.
• Leads and participates in audit preparation and inspections by certifying agencies and regulatory bodies, i.e. NSF and FDA
• Stay abreast of industry regulations and ensure compliance with relevant quality standards and certifications.
• Coordinate internal and external audits, ensuring adherence to regulatory requirements and industry best practices.
• Foster a culture of quality and compliance awareness throughout the organization.

MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS

• Bachelor's Degree in Engineering, Quality Management, or a related field. Advanced degree preferred.
• Minimum of 10 years experience in the area of Food Safety and Quality in an FDA-regulated manufacturing environment; to include a minimum of 5 years in a leadership capacity
• Minimum of 3 years of managing regulatory requirements that affect the dietary supplement and/or pharmaceutical manufacturing business
• In-depth knowledge of quality systems, standards, and methodologies such as ISO, FDA, and cGMP.
• Strong leadership abilities with the capacity to inspire and motivate cross-functional teams.
• Experience in driving continuous improvement initiatives and utilizing quality tools and methodologies.
• Excellent analytical and problem-solving skills, with the ability to make data-driven decisions.
• Effective communication and interpersonal skills to collaborate with diverse stakeholders.
• Strong project management abilities to drive quality initiatives and meet deadlines.
• Experience in leading and managing audits and regulatory inspections.
• Professional certifications in quality management (e.g., ASQ, Six Sigma) are highly desirable.

WORK ENVIRONMENT

• Duties are performed primarily in a smoke-free office and production environment

PHYSICAL REQUIREMENTS

• Frequent sitting
• Able to lift up to 25 lbs.

BENEFITS AND COMPENSATION

ProCaps Laboratories provides competitive compensation, commensurate with your experience and the position’s responsibilities, along with a comprehensive benefits package, which includes:

• Excellent Medical Insurance
• Excellent Dental Insurance
• Excellent Vision Insurance
• Paid Time Off, Holiday Pay
• 401K matching program after 60 days of employment
• 100% Company Life and Short-Term Disability Coverage
• Health & Wellness Program
• Reimbursement for Gym Membership Fee
• Vitamin Allowance/Discounts up to 90%
• Company Funded - Health Savings Account

ProCaps Laboratories is an equal opportunity employer and values diversity in our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Depending on the volume of interests and submissions, we will only be contacting applicants who meet all of the minimum requirements listed in the job description. Only those applicants who align most closely with our minimum and preferred qualifications will be contacted for an interview. ProCaps Laboratories will retain your application materials for one year and may contact you regarding future opportunities.

For more information please visit us at:

• www.ProCapsLabs.com
• The Andrew Lessman brand store on Amazon.com
• Andrew Lessman on HSN.com (Home Shopping Network)