Director of Quality

2 days ago

Reading, United States Custom Processing Services Full time

Summary:

The Director of Quality will lead and oversee the QMS including Quality Culture, Quality Assurance (QA), Quality Control (QC), cGMP regulations, Food Safety, and ISO Certification functions within the manufacturing environment. This role ensures that all customer products meet their highest standards of safety, reliability, and compliance while maintaining industry regulations. The Director of Quality will work closely with Business Unit Leaders, cross-functional teams, including production, engineering, and supply chain, to drive continuous improvement initiatives in product quality, process efficiency, and customer satisfaction. The Director of Quality is the internal subject matter expert within the organization for cause and corrective action, defect and process error trend analysis, and statistical analysis.

People Focused:

Lead, mentor and develop all quality personnel.

Assure quality personnel work in a manner of safety always' - safe environment; safe process and methods; safe behaviors.

Establish, maintain/improve, and measure a culture of quality within the Business Units.

Utilize existing and help develop new quality training tools to ensure quality is integrated into all Business Units.

Foster a culture of quality engagement, accountability, teamwork, and continuous improvement for all employees within the Business Units.

Use information learned through quality employee engagement to create growth and developmental plans for all Quality employees, aligning with their personal aspirations.

Customer Focused:

Ensure all products meet customer specifications and requirements; and that they are understood, communicated, and implemented.

Provide profound, timely, and appropriate communications to customers and work closely with the sales and account management teams to provide quality support for customer interactions, including audits, inspections and other quality related items.

Lead root cause analysis and implement corrective actions for quality-related issues. Ensure the customer complaint management system is efficient and effective.

Optimize the release process to assure product is made available to customers when expected.

CPS Focused:

Measure and work with Business Unit Leaders to improve first pass quality.

Develop, implement, and continuously improve the company's QMS in alignment with applicable ISO standards, GMP requirements, and other relevant regulations (e.g., FDA, Kosher etc.)

Design and implement testing methodologies and best practices, share knowledge and expertise

Assure certifications are maintained and ensure compliance with industry standards, customer specifications, regulatory requirements, cGMP processes, and training programs to make certain all staff adhere to all of the above.

Introduce new or enrich existing processes to improve methodologies to enhance product quality, reduce defects, and improve departmental efficiencies.

Identify and execute opportunities for quality process optimization, working with other subject matter experts to reduce costs, improve lead times, and increase customer satisfaction.

Provide Risk Assessments and Avoidance Plans for the general business within the ISO platforms including data analysis, trending, and forecasting etc.

Oversee the management of internal audits, non-conformance reports, corrective and preventive actions, and deviations to ensure timely resolution and continuous improvement.

Assist with and assure the quality department operates within the financial budget.

Working with Quality Leaders, own the quality purchasing process to control supplies, needs etc.

Notable specific subsets of above:

Periodic evaluation of business needs as it relates to quality and communication of needs to corporate management if needs are not readily available within DoQ defined responsibility scope.

Sharing of your knowledge and expertise with others in the Business Units to improve business execution

Direct reporting and oversight of quality personnel

Responsible for quality information systems including Deacom (ERP) and Paycor operation.

Required Qualifications:

Bachelor's degree in Business, a Quality Engineering discipline, or a related field preferred.

10-20 years of experience in Quality Assurance, Quality Control, ISO oversight and 5-10 years of Organizational Quality Leadership experience

Strong experience with cGMP compliance and regulated industries

Proven knowledge of QMS's (e.g. ISO9001, FSSC22000) and experience with regulatory and customer audits

Understanding of Lean Six Sigma, or other process improvement methodologies preferred.

Excellent problem solving and root cause analysis skills

Champion and embodiment of CPS Core Values

Willingness to work as part of a collaborative team, promoting trust and respect.

Excellent communication skills, both written and oral, including proficiency in Office Suite applications including flow charting, graphs, and pivot tables etc.

Willingness to accept the demands of a 24/7 manufacturing operation

Establish priorities in an environment of competing expectations.

Willingness to continue education and personal development for the purposes of staying up to date with industry, technology, and regulatory requirements.

Desire to be a change agent, not getting discouraged, but persevering through times of conflict.

Flexible and openminded to change while at the same time being able to hold an unwavering position.

Previous experience in developing personnel.

Ability to analyze data, perform trend analysis, and draw conclusions from said data

Growth Opportunities:

Senior Management, Strategic initiatives

Travel Requirements:

To vendor locations as needed to support audits, learning, and equipment/process advancement

To industry or technical conferences to advance learning and understanding of new technologies

To customer sites for audits, corrective action follow up, or in support of business development

Between CPS manufacturing facilities and offsite warehouses will be required from time to time

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