Company Philosophy: The company has built its reputation in the marketplace

by demanding high standards for all of its employees. The company’s success is measured by its integrity, honesty, and quality products at a fair price with exemplary service to its customers.  This position requires an individual with a superb skill set that excels in service to internal customers, is a team player, demonstrates a strong sense of urgency, and can build and maintain strong relationships with suppliers.  Beyond the technical qualifications of the position, it is important that the individual demonstrates a character with strong family values and a willingness to build a solid working relationship with others with hands-on ownership.

Purpose and role of job:

The Quality Manager is responsible for the creation, implementation and monitoring of all corporate & site Quality practices within their site of operation.  Leading a team of quality professionals and driving a culture of continual improvement.  Play a pivotal role and work collaboratively within the site management team, and drive quality engagement through all levels of the organization.

Principal Accountabilities/ Responsibilities:

Provide leadership and planning to develop, implement and maintain quality systems to ensure compliance to regulatory, industry, and customer standards.Serves as the Management Representative for all site compliance and quality systemsSupervises the activities of assigned staff and monitor the activities of QA/QC personnel within the QA Department. Assure that all resources utilized for the quality functions are procured, maintained, and perpetuated in a cost effective and timely manner within the goals of the strategic business plan.Take the leadership role in maintaining/changing the quality culture of the company – serve as the visible model of Quality. Educate team members in the quality philosophy and practices, including improvement strategies.Represents the company to vendors, customers, and appropriate regulatory officials in matters related to quality.Administers the quality audit program.Provides training to team members, as required, for implementing quality initiatives.Work with cross-functional teams to prioritize key site projects and determine appropriate resources and timing; integrate lean six sigma activities with quality system activities such as Corrective and Preventive Action (CAPA) and Quality Improvements to assure effectiveness and compliance to customer and regulatory requirements.Develops annual quality plans and recommendations for continual improvement in conjunction with the Quality Leader and Operations ManagerDetermines methods and implements plans for professional development of personnel within the QA Department.Proposes budgets and monitors budget activity for the QA Department.Provides statistical analysis for evaluation of processes, and issue KPI reports to site leadership and divisional leaders at determined frequencies.Conducts lab tours and explains quality system to visitors.Understands competitive product features in comparison to products.Completes required reports and summaries for regulatory & industry agencies.Assists and substitutes for the Divisional Quality Leader, as needed.Observes all safety rules and always uses the proper safety equipment.Performs other duties as necessary when directed to do so.Follows necessary GMP, FDA, and ISO regulations.Manage master validation plan.Implement, monitor and review online Quality systems, including vision QMS Software, and SPC systems.

Qualifications/ education and experience requirements:

(e.g. degrees, certificates of specific trainings)

Bachelor’s degree in an Engineering, Technology, Mathematics, Business, or Science discipline.Three years minimum experience as a Quality Manager, Technical Manager, or QC Supervisor in a manufacturing environment (preferably FDA-regulated environment).Six sigma Green Belt certified, preferred.Supervisory experience.Auditing experience in GMP and/or ISO systems.ASQ Certification or equivalent training (CQE, CQA, CQT, or CQM).

Skills/ competencies requirements:

(e.g., analytical, teamwork, problem solving, ability to use certain equipment, etc.)

Advanced skills in oral and written communications.Standard skills in technical, business, and managerial fields.Standard skills in statistics, procedure implementation, and quality auditing.Competent in interactions with executive management, vendors, and customers.

Direct Reports (if applicable):

Quality Specialist, Quality Engineers, Document Control and Document Control Lead, Quality Operations Leaders

Disclaimer:

The above information on this job description has been described to indicate the general nature and level of work performed by incumbents.  Other duties and responsibilities not specifically described may be assigned from time to time, consistent with knowledge, skills, and abilities of the incumbent.

** The most qualified candidate will be selected for the position**

Number of Openings: 1

Req#: 9463

The closing date to apply will be: July 24th, 2025

First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations.  As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.

First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.