Manager, Quality Engineering ADD

Summary of Objective:

The position is responsible for leading and directing the Quality Engineers for the Advanced Drug Delivery segment at the Rockford, IL site. The position is responsible for balancing client and product timeline commitments, ensuring the product is produced according to the established control plan, design and product specifications, and driving continual improvement to ensure ongoing standardization, simplification, and optimization of the product manufacturing-assembly and final packaging processes. This role will interact and collaborate with internal team members, customers, suppliers, and contract service providers.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Provides leadership over the Quality Engineering (QE) team that is involved in supporting design transfer, risk management, statistical analysis of data, deviations, complaints, change management, and quality improvement projects.

• Direct oversight over Quality Engineers responsible for Advanced Drug Delivery business segment

• Leads QE team to support New Product Introduction and tech transfer for product launches as well as supporting the sustaining commercialized products

• Accountable for overall management, reviewing, planning, and administering of resource allocation and workload planning for the Quality Engineering staff.

• Oversee and administer site risk management program aligned to ISO 14971

• Oversee and approve PCI investigations including consumer complaints, trend investigations, calibration OOS, and laboratory or environmental monitoring product impact investigations.

• Oversee and approve site supplier non-conformances and supplier-related quality metrics

• Oversee generation of documentation such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R, test requirements, and Test Method Transfer/Validation.

• Technical evaluation of change controls including risk assessment/implementation of risk mitigation strategies.

• Apply scientific statistical analysis techniques to proactively identify trends, identify root causes, and implement actions to mitigate reoccurrence.

• Statistical assessment of data to drive improvements.

• Supports and maintains quality assurance programs and systems, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.

• Participates as a member in various steering committees to guide and influence the company's focus on new products, new customers, and strategic initiatives.

• Prepares reports to company management detailing the status of open projects that support the capacity, regulatory, and quality improvement requirements of the plant.

• Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.

• Establishes and ensures the Quality Engineering team achieves the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPIs.

• Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.

• Partners with internal teams (Business Unit, Quality, Operations, Engineering, Validation) to achieve company goals

SUPERVISORY RESPONSIBILITIES:

• Leads a group of up to 10 direct reports.