Quality Manager

Summary:

Manages and directs the operations site toward its primary quality objectives, based on product and profitability goals, by performing the following duties personally or through subordinate managers.

Essential Duties and Responsibilities:

include the following. Other duties may be assigned.

• Guide the organization to follow the Quality Policy and Principles

• Actively communicate, support, and drive the quality goals and strategies, to motivate the organization towards a culture of continuous improvement and customer satisfaction

• Supervises and manages all quality-related activities at the site by showing active leadership (quality manual and harmonized quality processes), with the goal to continuously maintain and improve customer satisfaction

• Works and communicates actively with external and internal customers, as well as internal functions and members within the organization to drive quality improvements.

• Provides the voice of the customer (VOC) as needed to ensure customer satisfaction

• Supports the investigation of customer and internal customer complaints for appropriate customer issue resolution (CIR), based on the severity of the complaint and customer requirements, up to and including containment processes and corrective and preventive actions (CAPA). The goal being to provide a timely, effective, and professional response to the customer.

• Utilizes various root cause analysis (RCA) techniques and rational thinking skills (RTS).

• Supports the investigation of quality nonconformities relating to vendor product, process, and service issues.

• Supports the company strategies and leads and participates in site quality improvement process (QIP) teams, utilizing various tools including RCA and RTS to improve the cost of poor quality (COPQ).

• Training of quality tools, processes, and protocols across the organization to ensure a quality product and process.

• Participates actively with other site Quality Managers on related issues

• Leads and/or participates in customer, external, and vendor audits and improvement programs as required.

• Leads and/or participates in customer visits as required for issue resolution. This may include identification and clarification of complaints and/or determining alternate options for issue resolution.

• Responsible for facility cGMP, hygiene, and ISO controls and protocols.

• Responsible for maintaining all necessary product inspection equipment, including calibration and maintenance.

• Responsible for developing and managing key performance indicators (KPIs) for the on-site Quality team, including metrics aligned with operational performance, quality objectives, and financial goals.

Directly manages local quality team, as applicable, within a specific operations site. Review the structure of the quality organization and implement new ideas to lead the team towards RIGHT quality. Carries out managerial responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees;

addressing complaints and resolving problems.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Associate’s degree (A.S.) or equivalent; or three to five years related experience and/or training; or equivalent combination of education and experience. Training in Six Sigma principles,…