Job Summary:

The Quality Director is responsible for the overall quality assurance, quality control and regulatory strategy and performance of the organization. They will develop and implement policies and procedures related to quality and ensure compliance with national and international standards and regulations. The Quality Director will lead a team of quality professionals and ensure that the organization meets customer requirements, while also ensuring the efficient use of resources. The Quality Director will also review and analyze quality data to identify trends and develop improvement strategies. This role requires strong leadership and communication skills, as well as a solid understanding of quality management principles.

Duties/Responsibilities:

• Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.

• Collaborates with management and senior staff across production departments and roles to draft acceptable quality standards.

• Develops and implements quality standard testing and evaluation processes.

• Facilitates communication among production divisions and management.

• Assesses test results and approves recommended changes.

• Reviews quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance.

• Conducts random inspections, internal quality audits and quality control checks.

• Periodically reports status of quality control and operations to executive leadership and, when required, regulatory agencies.

• Performs other related duties as assigned.

• Directs and oversees the quality department and supervisory staff.

• Conducts performance evaluations that are timely and constructive.

• Handles discipline and termination of employees in accordance with company policy. Develop and implement quality systems and procedures.
• Ensure compliance with relevant legal and regulatory requirements.
• Monitor and review product quality.
• Analyze and report on product and process performance.
• Identify and investigate customer complaints.
• Develop corrective actions where necessary.
• Liaise with other departments to ensure quality standards are being met.

Required Skills/Abilities:

• Excellent verbal and written communication skills with the ability to train staff.

• Thorough understanding of quality control standards and methodologies.

• Thorough understanding of manufacturing and production in the industry.

• Prior experience in working with regulatory agencies such as FDA.
• Excellent organizational skills and attention to detail.

• Strong analytical and problem-solving skills.

• Strong supervisory and leadership skills.

• Proficient with Microsoft Office Suite or related software.

Education and Experience:

• Bachelors degree in Engineering or related industrial, scientific, or business field required; Masters degree preferred.

• Eight to 10 years of related experience required with at least five years as a quality engineer or similar role highly preferred.

Job Type: Full-time

Pay: $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person